Our company provides internationally approved and accredited testing, inspection and inspection services to the following standards.
TS EN 27740 Surgical instruments, removable head scalpels - Connection sizes
TS 3521-1 EN 20594-1 Conical fittings% 6 (luer) syringes used in tapered medicine needles and other medical supplies section 1-General specifications
TS EN 61206 Ultrasound-Continuous wave doppler sratems-Test methods
TS EN 61168 Radiotherapy simulators, functional performance characteristics
TS EN 61223-2-4 Evaluation and routine testing in medical imaging departments-Section 2-4: Stability tests-Printing cameras
TS EN 61223-2-5 Evaluation and routine trial in medical imaging departments-Section 2-5: Stability tests-Display screens
TS EN 61262-2 Electrical medical devices - Electro-Optics x- Characteristics of the image intensifiers section 2: Determination of the conversion factor
TS EN 61266 Ultrasonic-Doppler fetal heartbeat detectors with hand probes-Performance characteristics and measurement methods and reporting
TS EN 60601-3-1 Medical electrical equipment - Part 3-4: Basic performance rule for oxygen and carbon dioxide partial pressure monitoring equipment passing through the skin
TS EN ISO 11985 Ophthalmic optics - Contact lenses - Aging of contact lenses with UV and visible radiation (in vitro method)
TS EN 60601-2-40 Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and call answering equipment
TS EN ISO 7886-2 Disposable hypodermic syringe - Part 2: Syringes for use with force-driven syringe pump
TS EN 1617 (Former no: TS prEN 1617) Disposable sterile drainage catheters and ancillary equipment
TS EN 60522 Determination of permanent filtration of X-ray tube system
TS EN 13014 Gas samples for anesthetics and breathing apparatus tube connections
TS EN 1618 Catheters other than intravenous catheters - Test methods for common properties
Surgical implants - Metallic materials - Part 5832: Non-alloy titanium TS EN ISO 2-9371 (Former number: TS 5832 ISO 2-2)
TS EN 60526 Cables - Plug and socket connections for high-voltage cable for medical x-ray machine
TS EN ISO 14729 Optics - Eye care - Contact lens care products - Microbiological rules and test methods for hygienic systems and products
TS EN ISO 11985 Optics - Eye - Contact lenses - Aging by exposure to UV and visible radiation (in vitro method)
TS EN 60522 Determination of permanent filtration of X-ray tube systems
TS EN ISO 14729 Optical and optical instruments - Contact lenses and contact lens care products - Antimicrobial activity of products for disinfection of contact lenses
TS EN 14820 Sample cups for collecting human venous blood samples - One time
TS EN 61828 Ultrasonic - Focusing transducers - Definitions and measurement methods for transmitted areas
TS EN 61828 Ultrasonic - Focusing transducers - Definitions and measurement methods for transmitted areas
TS EN ISO 16054 Surgical implants - Minimum data sets for surgical implants
TS EN 45502-2-1 Active implantable medical devices - Part 2-1: Specific features for active implantable medical devices designed for the treatment of bradyarrhythmia (pacemakers)
TS EN 60806 Determination of the largest symmetrical radiation field from a rotating anode x-ray tube for medical diagnosis
TS EN ISO 8871-2 Elastomeric parts for devices for parenteral and pharmaceutical use - Part 2: description and characteristics
TS EN ISO 8871-3 Elastomeric parts for devices for parenteral and pharmaceutical use - Part 3: Determination of the number of particles released
TS EN 13014 / AC Gas samples for anesthesia and breathing apparatus tube connections
tst EN ISO 5840 Cardiovascular implants - Heart valve prostheses
Pressure regulators for medical gases - Section 10524: Pressure regulators and flow fast pressure regulators
TS EN ISO 21647 / tst AC Electrical medical equipment - Specific requirements for the essential performance and essential safety of respiratory gas monitors
Pressure regulators for use with medical gases - Section 10524: Manifold and line pressure regulators
Pressure regulators for use with medical gases - Section 10524: Integrated pressure regulators with cylinder valves
TS EN ISO 10993-2 Biological evaluation of medical devices - Part 2: Animal health characteristics
TS EN ISO 19054 Supporting rail systems for medical equipment
TS EN ISO 19106 Geographical information-Profiles
TS EN ISO 11979-5 Ophthalmic implants - Interocular lenses - Part 5: Biocompatibility
TS EN ISO 11979-10 Optics - Eye implants - Intraocular lenses - Part 10: Phakic intraocular lenses
TS EN 14931 Pressure vessels for human use (pvho) - Pressure chamber systems with multiple seats for hyperbaric treatment - Performance, safety requirements and tests
TS EN 60601-1 Electrical medical equipment - Part 1: General rules for basic safety and required performance
TS EN ISO 8871-4 Elastomeric parts for devices for parenteral and pharmaceutical use - Part 4: Biological properties and test methods
TS EN ISO 18369-3 Optics - Eye-related - Contact lenses - Part 3: Measurement methods
TS EN ISO 18369-4 Optics - Eye-related - Contact lenses - Part 4: Physicochemical properties of contact lens materials
TS EN ISO 8980-1 / AC Optics - Eye-related - Uncut, ready-to-use eyeglass lenses - Part 1: Technical specifications of single and multifocal lenses
TS EN ISO 8980-2 / ACOptic - Eye-related - Uncut, ready-to-use eyeglass lenses - Part 2: Technical specifications of improved power lenses
TS EN 60601-1 Electrical medical equipment - Part 1: General rules for basic safety and required performance
TS EN ISO 7396-2 Medical gas piping systems - Part 2: Anesthetic gas release systems
TS EN 62464-1 Magnetic resonance equipment for medical imaging - Part 1: Determination of the required image quality parameters.
TS EN 60601-1-8 Electrical medical equipment - Part 1-8: General rules for basic safety and required performance - Supplementary standard: General specifications, tests and guidance for electrical medical equipment and warning systems in electrical medical systems
TS EN ISO 9170-1 Terminals for medical gas pipeline systems - Part 1: Terminals for compressed medical gases and vacuum
End units for medical gas pipeline systems - Part 9170: End units for anesthetic gas cleaning systems
Flow meters for connection to terminal units of medical gas pipeline systems TS EN ISO 15002
TS EN ISO 8536-3 Infusion equipment for medical use - Part 3: Aluminum caps for infusion bottles
Flow meters for connection to terminal units of medical gas pipeline systems TS EN ISO 15002
Optics - Eye - Contact lenses - Part 18369: Recommendations for terms, classification system and labeling specifications TS EN ISO 1-1 / A1
TS EN ISO 14889 Optics - Eye - Eyewear lenses - Basic requirements for uncut, ready-to-use lenses
TS EN ISO 7944 / tst AC Optical and optical instruments - Reference wavelengths
60601-2-20 Electrical medical equipment - Part 2-20: Specific requirements for the basic safety and performance of infant transport incubators
TS EN 12312-16 + A1 Aircraft ground support equipment - Special requirements - Part 16: Air start equipment
TS EN ISO 8185 Humidifiers for medical use - General features for humidification systems
Breathing system filters for inhalation and anesthesia use - Part 23328: Non-filtration properties
TS EN ISO 21649 Needle-free syringes for medical use - Specifications and test methods
TS EN ISO 21536 Inactive surgical implants - Joint implants - Specific features for knee joint implants
TS EN ISO 21535 Non-active surgical implants - Joint replacement - Specific features for hip replacement
TS EN ISO 21534 Inactive surgical implants - Joint replacement - Specific features
TS EN ISO 18778 Breathing equipment - Newborn monitors - Specific features
TS EN ISO 11981 Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lenses and contact lens care products
TS EN ISO 8536-3 Infusion equipment for medical use - Part 3: Aluminum caps for infusion bottles
TS EN ISO 18777 Breathing equipment - Newborn monitors - Specific features
Optics - Eye - Contact lenses - Part 18369: Recommendations for terms, classification system and labeling specifications TS EN ISO 1-1 / A1
TS EN 60601-2-31 Electrical medical equipment - Part 2-31: Specific features for the safety of external pacemakers with an internal power supply
TS EN ISO 18777 Portable liquid oxygen systems for medical use - Specific features
TS EN 60601-2-54 Electrical medical equipment - Part 2-54: Particular requirements for the basic safety and required performance of x-ray equipment used in radiography and radioscopy
TS 3521-1 EN 20594-1 / AC Tapered fittings,% 6 (luer) taper - For syringes, needles and other medical supplies used in medicine - Part 1: General specifications
TS EN ISO 9360-2 Anesthetics and breathing equipment - Temperature and humidity changers (IDs) - Humidification of inhaled gases for humans - Part 2: Inds for use in patients undergoing tracheostomy with a minimum TNC volume of 250
Lung ventilators for medical use - Particular requirements for basic safety and performance - Part 10651: Respiratory support devices for home care
Sleep apnea breathing therapy - Part 17510: Sleep apnea respiratory therapy equipment
Sleep apnea breathing therapy - Part 17510: Masks and application accessories TS EN ISO 2-2
TS EN 20594-1 / AC Conical fittings% 6 (luer) syringes used in tapered medicine needles and other medical supplies section 1-General specifications
TS EN 301489-29 V1.1.1 Electromagnetic compatibility and radiospectrum issues (erm) Electromagnetic compatibility (emu) standard for radio equipment; Part 29: Special requirements for medical data service devices (meds) operating in the 401 mhz to 402 mhz and 405 mhz to 406 mhz bands
TS EN 80601-2-59 Medical electrical equipment - Part 2-59: Characteristics related to the basic safety and performance of the screen thermal graphics for monitoring human fever (IEC 80601-2-59: 2008 + corrected 2009)
tst EN ISO 8836 Suction catheters for use in the respiratory tract
TS ISO 7206-10 Surgical implants - Partial and full hip joint prostheses - Part 10: Determination of static load resistance of modular femoral heads
tst ISO 7206-8 Surgical implants - Partial and full hip joint prostheses - Part 8: Durability performance of rotating applied femoral components
TS ISO 7206-6 Surgical implants - Partial and full hip joint prostheses - Part 6: Test of the strength characteristics of the neck region of the stalked femoral components and performance rules
TS ISO 7206-1 Surgical implants - Partial and full hip joint prostheses - Part 1: Classification and indication of dimensions
TS ISO 7206-4 Surgical implants - Partial and full hip joint prostheses - Part 4: Determination of strength characteristics and performance of stem femoral components
TS ISO 7206-2 Surgical implants - Partial and full hip joint prostheses - Part 2: Movable surfaces made of metal, ceramic and plastic materials
TS EN ISO 14971 Medical devices - Applying risk management to medical devices (ISO 14971: 2007; Revised edition 2007-10-01)
TS EN 60601-1-6 Medical electrical equipment - Part 1-6: General rules for basic safety and required performance - Subsidiary standard: Ease of use
TS EN 60601-1-6 Medical electrical equipment - Part 1-6: General rules for basic safety and required performance - Subsidiary standard: Ease of use
TS EN 60613 Electrical, thermal and loading characteristics of rotary anode x-ray tubes for medical diagnosis
TS EN ISO 8536-2 Infusion equipment for medical use - Part 2: Caps for infusion bottles
TS EN ISO 9360-1 Anesthetic and breathing equipment - Temperature and humidity changers (IDs) - For humidification of breathing gases by humans - Section 1: Intds for use with minimum Tidal volumes of 250 ml
Lung ventilators for medical use - Part 10651 - Specific features for operator-operated resuscitators
X NUMX-60601-2 Electrical medical equipment - Part 19-2: Specific requirements for the basic safety and performance of baby incubators
60601-2-21 Electrical medical equipment - Part 2-21: Specific requirements for the basic safety and performance of radiant baby heaters
TS EN 60601-2-50 Electrical medical equipment - Part 2-50: Specific requirements for essential safety and required performance of baby phototherapy equipment
Tracheostomy tubes - Part 1282: Pediatric tubes (ISO 2-1: 2, modified)
TS EN ISO 7886-3 Syringes - Sterile hypodermic - Disposable Section 3: Self-unavailable syringes for fixed dose immunization
TS EN ISO 7886-4 Syringes - Sterile hypodermic - Disposable - Part 4: Disposable syringes
TS EN 60601-2-2 Electrical medical equipment - Part 2 - 2: Specific requirements for essential safety and required performance of high-frequency surgical equipment and high-frequency surgical accessories
TS EN 60601-2-44 Electrical medical equipment - Part 2-44: Specific requirements for the essential safety and required performance of X-ray equipment for computed tomography (IEC 60601-2-44: 2009)
TS EN ISO 8536-4 Infusion equipment for medical use - Part 4: Disposable infusion sets operated by gravity (ISO 8536-4: 2010)
TS EN ISO 9187-1 Injection equipment for medical use - Part 1: Ampoules for injectable medicines (ISO 9187-1: 2010)
TS EN ISO 9187-2 Injection equipment for medical use - Part 2: Single-point (TNK) ampoules (ISO 9187-2: 2010)
794-3 + A2 Lung ventilators - Part 3: Specific features for emergency use and patient transport ventilators
TS EN 1060-1 + A2 Non-invasive sphygmomanometer - Part 1: General features
TS EN 1060-3 + A2 Non-invasive sphygmomanometers - Part 3: Complementary features for electromechanical blood pressure measurement systems
TS EN 1820 + A1 Anesthetic reservoir balloons (ISO 5362: 2000, mod.)
Respiratory therapy devices - Part 13544: Piping system and fittings
Respiratory therapy devices - Part 13544: Air distribution devices
TS EN 60601-2-2 Electrical medical devices - Part 2-2: Specific features for the safety of diagnostic and therapeutic laser devices
60601-2-21 Electrical medical devices - Part 2: Special rules for the safety of baby radiant heaters
TS EN ISO 7886-4 Syringes-Sterile-Hypodermic-Disposable-Part 4: Syringes with anti-reuse properties
TS EN ISO 10342 Optics - Eye Devices - Eye refractometers
TS EN 61223-3-2 Routine testing and evaluation in medical imaging departments - Part 3 - 2: Acceptance tests - Imaging performance of mammography x-ray device
TS EN 60601-2-33 Electrical medical equipment - Part 2-33: Specific features for the safety of extracorporeal medical diagnostic magnetic resonance equipment
TS EN ISO 14729 / A1Optics - Eye care - Contact lens care products - Microbiological rules and test methods for hygienic handling systems and products -Edit 1 (ISO14729: 2001 / AM 1: 2010)
TS EN 45502-2-2 / AC Active implantable medical devices - Part 2-2: Specific features for implantable active medical devices designed to treat bradyarrhythmia (implantable defibrillators)
TS EN 60601-1 / AC Electrical medical equipment - Part 1: General rules for basic safety and performance required
TS EN 60601-1-8 / AC: 2010 Electrical medical equipment - Part 1-8: General rules for basic safety and required performance - Supplementary standard: General specifications, tests and guidance for electrical medical equipment and warning systems in electrical medical systems
TS EN ISO 11986 Optics - Eye - Contact lenses and contact lens care products - Determination of uptake and release of preservatives
Breathing system filters for inhalation and anesthesia use - Section 23328: Salt test method to assess filtration performance
Small probe fittings for liquids and gases in healthcare applications - Part 80369: General specifications
TS EN ISO 7886-3 Syringes-Sterile-Hypodermic-Disposable-Section 3: Automatic syringes that cannot be used automatically for fixed dose immunization
Electrical medical equipment - Part 60601-2: Particular requirements for the essential safety and required performance of external pacemakers with internal power supply (IEC 31-1-2: 31: 60601)
TS EN 62464-2 Magnetic resonance equipment for medical imagery - Part 2: Classification criteria for pulse sequences "
TS EN ISO 8362-6 Injection containers and accessories-Part 6: Caps for injection vials made of aluminum-plastic connections
TS EN 60601-2-52: 2010 / AC: 2011Electrical medical equipment - Part 2-52: Specific features for the basic safety and necessary performance of patient beds
TS EN ISO 9187-1 Injection equipment for medical use - Part 1: Ampoules for injectable medicines
TS EN ISO 9187-2 Injection equipment for medical use - Part 2: Single-point (opc) ampoules
TS EN 80001-1: 2011 Application of risk management for IT networks for medical devices - Part 1: Roles, responsibilities and activities
60601-2-21 / A11 Electrical and medical equipment - part 2-21: Particular requirements for basic safety and performance of radiant baby heaters
TS EN 60601-2-50 / A11 Electrical medical equipment - Part 2-50: Specific requirements for essential safety and required performance of baby phototherapy equipment
TS EN 16082 Airport and aviation security services
TS EN 60601-2-4 Electrical medical equipment - Part 2-4: Specific features for basic safety and significant performance of heart defibrillators
TS EN 60601-2-46 Medical electrical equipment - Part 2 - 46: Specific features for basic safety and significant performance of operating tables
TS EN ISO 10943 Ophthalmic instruments - Indirect ophthalmoscopes
Electrical medical equipment - Part 60601-2: Particular requirements regarding the basic safety and required performance of luminaires used in surgical interventions and diagnostics: TS EN 41-11-2 / A41
Electrical medical equipment - Part 60601-2: Particular requirements regarding the basic safety and required performance of luminaires used in surgical interventions and diagnostics: TS EN 41-11-2 / A41
Electrical medical equipment - Part 60601-2: Particular requirements regarding the basic safety and required performance of luminaires used in surgical interventions and diagnostics: TS EN 41-11-2 / A41
TS EN ISO 8362-4 Injection containers and accessories - Part 4: Injection vials made of molded glass
TS EN ISO 8536-1 Infusion equipment for medical use - Part 1: Glass infusion bottles
TS EN ISO 15747 Plastic containers for intravenous injection
80601-2-35 / A11 Medical electrical equipment - Part 2-35: Particularly relevant for the necessary performance and basic safety of heating devices intended for heating in medical use using blankets, pillows and mattresses
TS EN ISO 14602 Inactive (fixed) surgical implants - Implants for osteosynthesis - Specific features
TS EN ISO 11117 Gas cylinders - Valve protection caps and valve housings - Design, construction and testing
60601-2-2 / A11 Electrical medical equipment - Part 2-2: Specific requirements for basic safety and required performance of high-frequency surgical equipment and high-frequency surgical accessories
TS EN ISO 11608-2Pen injectors-for medical use-Part 2: Needles-Specifications and test methods
TS EN 61217 Radiotherapy equipment - Coordinates, motions and scales
TS EN 60731 Medical equipment - Ion chamber dosers for radiotherapy
TS EN ISO 8624 Optics - Eye - Eyeglass frames - Measuring system, terms and recipes
Optics - Eye - Contact lens care products - Microbiological rules and test methods for hygienic systems and products TS EN ISO 14729: 2001 / A1
TS EN ISO 7944: 1998 / AC Optical and optical instruments - Reference wavelengths
TS EN ISO 24598 Welding consumables - Solid wire electrodes for submerged arc welding of creep resistant steels, tubular flux cored electrodes and electrode powder / combinations - Classification
TS EN ISO 10685-1 Electronic catalog and identification of ophthalmic optical eyeglass frames and sunglasses-Part 1: Product description and electronic catalog product ranking
TS EN ISO 25539-3 Cardiovascular implants-Endovascular devices-Part 3: Vena cava filters
80601-2 Electrical medical equipment - Part 55-2: Specific requirements for basic safety and performance of respiratory gas monitors
TS EN ISO 8536-2 Infusion equipment for medical use - Part 2: Caps for infusion bottles
TS EN ISO 19980 Ophthalmic Instruments - Corneal topography
TS EN ISO 11608-3 Pen injectors - for medical use - Specifications and test methods - Part 3: Ready-made containers
TS EN ISO 11608-5 Pen injectors - for medical use - Specifications and test methods - Part 5: Automatic functions
Optics - Eye-related implants - Intraocular lenses - Part 11979: Labeling and information TS EN ISO 4-2008: 1 / A2012: 4
Electrical medical devices - Part 60601 -2: Particular requirements for the safety of X-ray equipment in computed tomography: TS 44-2009-1: 2 / A44
TS EN ISO 14971 Medical devices - Risk management application to medical devices
TS EN ISO 5356-2 Anesthetic and respiratory equipment - Tapered fittings - Part 2: Weight-bearing fasteners with screw heads
TS EN ISO 11980 Ophthalmic optics - Contact lenses and contact lens care products - Guide for clinical examinations
TS EN ISO 23907 Protection against cutting injuries - Properties and test methods - Part 3: Cutting containers
TS EN ISO 11979-3 Ophthalmic implants - Interocular lenses - Part 3: Mechanical properties and test methods
TS EN ISO 14630 Inactive surgical implants - General features
TS EN ISO 22665 Ophthalmic optics and instruments - Tools for measuring eye axial distances
TS EN ISO 25539-2 Heart and vascular implants-Section 2: Vascular stents
TS EN ISO 80601-2-13Electrical medical devices - Part 2-13: Particular requirements for basic performance and basic safety of anesthesia workstations
18369-2: Ophthalmic optics - Contact lenses - Part 2012: Tolerances
TS EN ISO 11987: 2012 Ophthalmic optics - Contact lenses - Determination of shelf life
TS EN ISO 10685-3: 2012 Ophthalmic optics-Electronic catalog and identification of spectacle frames and sunglasses-Part 3: Technical information
TS EN ISO 10341 Ophthalmic instruments - Refractory heads
Pressure regulators for use with medical gases - Section 10524: Pressure regulators with cylinder valves integrated in 3-1 / A3
TS EN 60601-2-65 Electrical medical devices - Part 2-65: Particular requirements for basic safety and required performance of dental intra-oral X-ray equipment
TS EN ISO 8536-4 Infusion equipment for medical use section 4: Disposable infusion sets operated by gravity
TS EN ISO 8536-5 Infusion equipment for medical use - Section 5: Disposable burette-type infusion sets operating under gravity
TS EN ISO 20072 Design verification of the Aeresol drug delivery device -Features and test methods
TS EN ISO 23908 Cutter injury protection - Characteristics and test methods - Disposable hypodermic needles, needles used for blood collection and catheters
TS EN ISO 5840-3 Cardiovascular implants - Cardiac valve prosthesis - Transcatheter replacement of heart valves
TS EN ISO 8536-4 / A1Infusion equipment for medical use part 4: Disposable infusion sets operated by gravity
TS EN ISO 19001 Extracorporeal medical diagnostic devices - Information provided by the manufacturer with extracorporeal medical diagnostic reagents for staining in biology
TS EN 61157 / A1 Ultrasonic devices - used in medical diagnosis - Acoustic output declaration rules
TS EN 61689 Ultrasonic-Physical Therapy Systems-Field characteristics and measurement methods in the frequency range 0,5 mhz to 5 mhz
TS EN ISO 11117 Gas cylinders - Valve protection caps and valve casings - Design, construction and testing
TS EN 80601-2-30 Electrical medical equipment - Part 2-30: Specific features for safety, including the required performance of noninvasive automatic repeated blood pressure monitoring equipment
tst EN ISO 13666 Ophthalmic optics - Glasses lenses - Terms (ISO 13666: 2012)
TS EN ISO 11979-1 Eye implants - Intraocular lenses - Part 1: Terms and descriptions (ISO 11979-1: 2012)
TS EN 61676 / A1 Electrical medical devices - Dosimetric instruments for non-invasive measurement of X-ray tube voltage in diagnostic radiology (IEC 61676: 2002 / A1: 2008)
TS EN ISO 3826-1 Plastic collapsible bags for human blood and blood components - Part 1: Conventional blood bags
TS EN ISO 10555-1 Intravenous catheters - Sterile disposable - Section 1: General specifications (ISO 10555-1: 2013, Adjusted edition 2013-07-01) 31.12.2014
TS EN ISO 10555-3 Intravenous catheters - Sterile, single-use - Part 3: Central venous catheters
60601-2-45-2 Electrical medical devices - Part 45-XNUMX: Specific requirements for the safety of mammographic x-ray equipment and mammographic stereotactic devices and their required performance
TS EN ISO 3826-1 Plastic foldable bags for human blood and blood components - part 1: Conventional blood bags
TS EN ISO 10555-1 Intravenous catheters - Sterile, single-use - part 1: General features
TS EN ISO 10555-3 Intravenous catheters-Sterile, single-use-Section 3: Central venous catheters
TS EN ISO 10555-4 Intravenous catheters-Sterile, single-use-Section 4: Balloon expansion catheters
TS EN ISO 10555-5 Intravenous catheters-Sterile, single-use-Part 5: Peripheral catheters with needle
TS EN 60601-1-3 / A1Electrical medical devices section 1: General rules for safety - Part 1.3 standard for general diagnostic purposes for the protection of radiation in the x-ray device for diagnostic purposes
60601-2-20 / A11 Electrical and medical equipment - Part 2-20: Specific requirements for the basic safety and performance of the baby transport incubators
60601-2-33 / A11 Electrical medical equipment - Part 2-33: Specific features for the safety of extracorporeal medical diagnostic magnetic resonance equipment
TS EN ISO 80601-2-12Electrical medical equipment - Part 2-12: Specific features for the safety of lung ventilators - Intensive care ventilators
TS EN 16081 + A1 Pressure Chambers - Special requirements for fire fighting systems - performance, application and testing
Electrical medical equipment - Part 60601-2: Particular requirements regarding the basic safety and required performance of surgical luminaires used in surgical interventions and diagnostics TS EN 41-2009-11: 2 / A41
Electrical medical equipment - Part 60601-2: Particular requirements regarding the basic safety and required performance of surgical luminaires used in surgical interventions and diagnostics TS EN 41-2009-11: 2 / A41
Electrical medical equipment - Part 60601-2: Particular requirements regarding the basic safety and required performance of surgical luminaires used in surgical interventions and diagnostics TS EN 41-2009-11: 2 / A41
TS EN 1041 + A1 Information supplied by the manufacturer with medical devices
TS EN ISO 15798 Ophthalmic Implants - Ophthalmic Visco Surgical Instruments
TS EN ISO 8980-3 Ophthalmic optics - Uncut glasses lenses - Part 3: Permeability characteristics and test methods
TS EN ISO 14889 Optics - Eye - Eyeglass lenses - Basic rules for uncut, ready-to-use lenses
TS EN 1041 + A1 Information provided by medical device manufacturers
TS ISO 7206-10 Surgical implants - Partial and full hip joint prostheses - Part 10: Determination of the resistance of modular femoral caps to static loads
TS EN ISO 11499 Dentistry - disposable cartridges for local anesthetics
Non-invasive blood pressure monitor - Section 81060: Clinical investigation of the types of automated measurement
TS EN ISO 10079-2 Medical aspirators (suction equipment) - Part 2: Manually operated aspirators
Medical aspirators (suction equipment) - Part 10079: aspiration equipment supplied by vacuum or pressure source
TS EN ISO 8871-2 / A1 Elastomeric parts for devices for pharmaceutical and pharmaceutical use - Part 2: Description and characteristics-Amended 1
TS EN ISO 18082 Anesthesia and breathing equipment - NIST low pressure connectors for medical gases
TS EN ISO 10343 Ophthalmic Instruments - Ophthalmometers
80601-2-69 Electrical and medical equipment - Part 2-69: Particular requirements for the basic safety and performance of the oxygen concentrator
11979-2 Optics - Eye implants - Intraocular lenses - Part 2: Optical properties and test methods
Optics - Eye implants - Intraocular lenses - Part 11979: Multifocal intraocular lenses TS EN ISO 9-1 / A9
11979-2 Optics - Eye implants - Intraocular lenses - Part 2: Optical properties and test methods
Optics - Eye implants - Intraocular lenses - Part 11979: Multifocal intraocular lenses TS EN ISO 9-1 / A9
TS EN 60601-2-43 / ACElectrical medical devices - Part 2-43: Particular requirements for the safety of x-ray equipment for interfering methods
TS EN 60601-2-27 Medical electrical equipment - Part 2-27: Specific requirements for the required performance and safety of electrocardiographic monitoring equipment
TS EN ISO 8598-1 Optics and optical instruments - Fucometers - Part 1: General-purpose instruments for measuring spectacle lenses
TS EN ISO 11979-7 Optics - Eye-related - Implants - Intraocular lenses - Part 7: Clinical trials
TS EN ISO 13212 Ophthalmic optics - Contact lens care products - Guidance for determination of shelf life
TS EN ISO 5359 Anesthesia and breathing equipment - Low pressure hose fittings for use with medical gases
TS EN ISO 5367 Anesthesia and Respiratory Equipment - Breathing sets and fittings
Suction catheters used in respiratory tract TS EN ISO 8836
Suction catheters used in respiratory tract TS EN ISO 8836
TS EN ISO 11978 Ophthalmic optics - Contact lenses and contact lens care products - Labeling
TS EN ISO 11979-6 Optics - Eye - Implants - Intraocular lenses - Part 6: Shelf life and transport stability test
TS EN ISO 12870 Ophthalmic optics - Spectacle frames - Rules and test methods
TS EN ISO 14730 Optics - Eye care - Contact lens care products - Antimicrobial protection efficacy test and expiry date determination guide
TS EN 60601-1 / A12 Electrical medical equipment - Part 1: General rules for basic safety and required performance
TS EN 61331-1 X-ray protective devices for diagnostic purposes in medicine Section 1: Determination of the attenuation properties of materials
TS EN 61331-2 X-ray protection devices for medical diagnosis - Part 2: Translucent protective plates
TS EN 61331-3 X-ray protective devices for medical diagnosis - Part 3: Protective clothing, goggles and protective patient armor
TS EN 62353 Electrical medical equipment - Retest and test after repair of electrical medical equipment
TS EN 13718-1 Medical instruments and equipment - Air ambulances - Part 1: Characteristics of medical devices used in air ambulances
TS EN ISO 11990-1 Lasers and laser-related equipment - laser resistance determination in tracheal tubes - Part 1: Tracheal tube shaft
TS EN ISO 11990-2 Lasers and laser-related equipment - laser resistance determination of tracheal tubes - Part 2: Tracheal tube cuffs
TS EN ISO 21536 / A1 Non-active surgical implants - Joint implants - Specific features for knee joint implants-Amended 1 (ISO 21536: 2007 / Amd 1: 2014)
tst EN ISO 11979-10 Optics - Eye implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-10: 2006)
Optics - Eye implants - Intraocular lenses - Part 11979: Phakic intraocular lenses (ISO 10-1: 10 / Amd 11979: 10)
tst EN ISO 11979-2 Optics - Eye implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2: 2014)
tst EN ISO 11979-9 Ophthalmic implants - Interocular lenses - Part 9: Multifocal interocular lenses (ISO 11979-9: 2006)
Ophthalmic implants - Interocular lenses - Part 11979: Multifocal interocular lenses (ISO 9-1: 9 / Amd 11979: 9)
tst EN ISO 8871-5 Elastomeric parts for devices for parenteral and pharmaceutical use - Part 5: Functional requirements and tests
TS EN 61675-1 Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomography devices (IEC 61675-1: 2013)
TS EN ISO 8638 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for hemodializers, hemodiafilter and hemofiltres
Elastomeric parts for devices for pharmaceutical and pharmaceutical use - Part 8871: Identification and characteristics - Amended 2 (ISO 1-2: 1 / Amd 8871: 2)
TS EN ISO 10079-2 Medical aspiration equipment - Section 2: Hand-operated aspiration equipment (ISO 10079-2: 2014)
10079-3 Medical aspiration equipment - Part 3: aspiration equipment supplied by vacuum or positive pressure source (ISO 10079-3: 2014)
TS EN ISO 10343 Ophthalmic instruments - Ophthalmometers (ISO 10343: 2014)
TS EN ISO 18082 Anesthesia and breathing equipment - Interchangeable thread (NIST) low pressure connectors for medical gases
S EN ISO 80601-2-69 Electrical medical equipment - Part 2-69: Specific requirements for basic safety and required performance of oxygen concentrator equipment (ISO 80601-2-69: 2014)
Non-invasive sphygmomanometers - Part 81060: Clinical investigation of the automatic measuring type (ISO 2-2: 81060)
TS EN 60601-2-43 Electrical medical equipment - Part 2-43: Specific requirements for essential safety and required performance of the X-ray equipment for interventional procedures (IEC 60601-2-43: 2010)
TS EN 60601-2-43 / AC Medical electrical equipment - Part 2-43: Specific requirements for essential safety and required performance of X-ray equipment for interventional procedures
tst EN 60601-2-34 Electrical medical devices - Part 2-34: Particular requirements for the safety of interventional blood pressure monitoring equipment including the required performance (IEC 60601-2-34: 2011)
TS EN 60601-2-27 Medical electrical equipment - Part 2-27: Specific features for the essential safety and required performance of electrocardiography monitoring equipment (IEC 60601-2-27: 2011 + Correction May 2012)
tst EN 60601-1-9 Electrical medical equipment - Part 1-9: General specifications for basic safety and performance required - Supplementary standard: Specification for environmentally conscious design (IEC 60601-1-9: 2007)
Electrical medical equipment - Part 60601-1: General requirements for basic safety and performance - Auxiliary standard: Specifications for environmentally conscious design (IEC 9-1-1: 9 / A60601: 1 )
tst EN 60601-1-8 Electrical medical equipment - Part 1-8: General rules for basic safety and required performance - Supplementary standard: General specifications, tests and guidance for electrical medical equipment and warning systems in electrical medical systems (IEC 60601-1-) 8: 2006)
Electrical medical equipment - Part 60601-1: General rules for basic safety and required performance - Supplementary standard: General specifications, tests and guidance for electrical medical equipment and warning systems in electrical medical systems (IEC 8) -1-1: 8 / A60601: 1)
TS EN 60601-1-8 / A1 Electrical medical equipment - Part 1-8: General rules for basic safety and required performance - Subsidiary standard: General specifications, tests and guidance for warning systems in electrical medical equipment and electrical medical systems
Electrical medical equipment - Part 60601-1: General requirements for basic safety and required performance - Supplementary standard: General specifications, tests and guidance for electrical medical equipment and warning systems in electrical medical systems
Electrical medical equipment - Part 60601-1: General rules for basic safety and required performance - Supplementary standard: General specifications, tests and guidance for electrical medical equipment and warning systems in electrical medical systems
60601-1 / tst A12 Electrical medical equipment - Part 1: General rules for basic safety and required performance
tst EN 60601-1-3 Electrical medical devices section 1: General rules for safety - Part 1.3 standard for general diagnostic purposes for radiation protection in the x-ray device (IEC 60601-1-3: 2008)
Electrical medical devices section 60601: General rules for safety - Part 1 general standard for the protection of radiation in the standard diagnostic x-ray device for diagnostic purposes (IEC 3-1-1.3: 60601)
Electrical medical devices section 60601: General rules for safety - Part 1 standard for general diagnostic purposes for the protection of radiation in the x-ray device (IEC 3-1-1: 1.3)
60601-1-3 / A1 / tst AC Electrical medical devices section 1: General rules for safety - Part 1.3 standard for general diagnostic purposes for radiation protection in the x-ray device for diagnostic purposes
TS EN ISO 8637 Cardiovascular implants and extracorporeal systems - Hemodializers, hemodiafiltrers, hemofiltrers, hemoconcentrators (ISO 8637: 2010 and Modified 1: 2013-04-01)
60601-2-44 / A1Electrical medical equipment - Part 2-44: Particular requirements for basic safety and required performance of X-ray equipment for computed tomography
TS EN ISO 11608-1 Pen syringes for medical use - Part 1: Pen syringes - Specifications and test methods
11979-8 Ophthalmic implants - Intraocular lenses - Part 8: Key features
TS EN ISO 14534 Optical and optical instruments - Contact lenses and contact lens care products - Key features
TS EN ISO 11070 Intravenous catheters - Sterile - Disposable catheter servers
TS EN 61910-1 Electrical medical equipment - Radiation dose documentation - Part 1: Formatted radiation dose report for radiography and radioscopy
TSE CEN / CLC / TR 14060: 2014 Ensuring traceability of medical devices with unique device identification (UDI)
TS EN 60731 Medical equipment - Ion chamber dosers for radiotherapy
Pressure regulators used in conjunction with medical gases - Section 10524: Manifold and line pressure regulators
Pressure regulators used in combination with medical gases - Section 10524: Pressure regulators integrated in cylinder valves
TS EN ISO 10524-3 / A1 Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves - Amendment 1: Filtering and information to be provided by the manufacturer
TS EN ISO 10524-4 Pressure regulators for use with medical gases - Part 4: Low pressure regulators
TS EN 60601-1-8 Electrical medical equipment - Part 1-8: General rules for basic safety and required performance - Supplementary standard: General specifications, tests and guidance for electrical medical equipment and warning systems in electrical medical systems
TS EN ISO 5356-1 Anesthesia and breathing equipment - Tapered fasteners - Section 1: Cones and sockets
TS EN 13718-2 Medical instruments and equipment - Air ambulances - Part 2: Technical and operating rules for air ambulances
TS ISO 5832-9 Surgical implants - Metallic materials - Part 9: Formable high nitrogen stainless steel
TS ISO 5832-12 Surgical implants- Metallic materials- Part 12: Formable cobalt- Chromium- Molybdenum alloy
TS ISO 10936-2 Optical and optical devices - Surgical microscopes - part 2: Dangerous radiation caused by surgical microscopes used in eye surgery
TS ISO 5832-11 Surgical implants - Metallic materials section 11: Formable titanium 6-Aluminum 7-Niobium alloy
TS ISO 11040-3 Pre-filled syringes - Section 3: Caps for local anesthesia cartridges of dentistry
TS ISO 11040-3 Pre-filled syringes - Section 3: Caps for local anesthesia cartridges of dentistry
TS ISO 8536-7 Infusion equipment for medical use - Part 7: Aluminum-plastic combination caps for infusion bottles
TS ISO 10985 Caps made of aluminum plastic combinations for infusion bottles and injection vials - Specifications and test methods
TS ISO 13405-1 Prostheses and orthoses - Classification and description of prosthetic components - Part 1: Classification of prosthetic components
TS ISO 13405-2 Prostheses and orthoses - Classification and description of prosthetic components - Part 2: Identification of lower limb prosthetic components
TS ISO 13405-3 Prostheses and orthoses - Classification and description of prosthetic components - Part 3: Identification of upper limb prosthetic components
TS 9371 ISO 5832-2 / T1 (Number Modification: TS EN ISO 5832-2) Surgical Implants-Metallic materials-Part 2: Titanium without alloy
TS EN ISO 5840-1 Cardiovascular implants - Heart valve prostheses - Part 1: General features
Cardiovascular implants - Heart valve prostheses - Part 5840: Surgically implanted heart valve substitutes TS EN ISO 2-2
TS EN ISO 16061 Instruments used with inactive surgical implants - General features
TS EN ISO 16061 Instruments used with inactive surgical implants - General features
TS EN ISO 8536-8 Infusion equipment for medical use - Part 8: Disposable infusion equipment for use with a pressure infusion device
TS EN ISO 8536-9 Infusion equipment for medical use - Part 9: Disposable fluid pathways for use with pressure infusion equipment
TS EN ISO 8536-10 Infusion equipment for medical use - Part 10: Accessories for disposable fluid pathways used in conjunction with pressure infusion equipment
TS EN ISO 8536-11 Infusion equipment for medical use - Part 11: Disposable infusion filters for use with pressure infusion equipment
TS EN 45502-1 Surgical implants - Active implantable medical devices - Part 1: General rules on safety, marking and information to be provided by the manufacturer
TS EN ISO 3826-4 Plastic collapsible bags for human blood and blood components - Part 4: Apheresis blood bag systems integrated with other components
TS EN ISO 8624 / A1 Ophthalmic optics - Spectacle frames - Measuring system, terms and descriptions
TS EN ISO 16671 Ophthalmic implants - Washing solutions for ophthalmic surgery
TS EN ISO 16672 Ophthalmic implants - Ocular inner pads
TS EN ISO 23747 Anesthetics and respiration related equipment - Peak exhalation flow meter for the assessment of lung function in spontaneous breathing
Electrical medical equipment - Part 60601-1: General rules for basic safety and required performance - Auxiliary standard: Ease of use TS EN 6-1-1 / A6
TS EN 60601-1-10 / A1Electrical medical equipment-Section1-10: General specifications for basic safety and required performance-Auxiliary standard: Features for the development of physiological closed-loop controllers
TS EN 60601-1-11 Electrical medical equipment - Part 1-11: General rules for basic safety and required performance - Subsidiary standard: Specifications for medical electrical equipment and medical electrical systems used in the domestic health environment
TS EN 60601-2-3 Electrical medical equipment - Part 2-3: Specific features for basic safety and required performance of short-wave therapy equipment
TS EN 60601-2-6 Electrical medical equipment - Part 2-6: Specific requirements for basic safety and required performance of microwave treatment equipment
TS EN 60601-2-10 Electrical medical equipment - Part 2-10: Specific requirements for essential safety and required performance of nerve and muscle stimulators
TS EN 60601-2-24 Electrical medical devices - Part 2-24: Specific requirements for essential safety and required performance of infusion pumps and controllers
TS EN 60601-2-26 Electrical medical devices - Part 2-26: Specific requirements for the essential safety and required performance of electroencephalography devices
TS EN 60601-2-26 Electrical medical devices - Part 2-26: Specific requirements for the essential safety and required performance of electroencephalography devices
60601-2-33 / A1 Electrical medical equipment - Part 2-33: Specific requirements for basic safety and required performance of medical diagnostic magnetic resonance equipment
TS EN 60601-2-33 / ACElectrical medical equipment - Part 2-33: Specific requirements for essential safety and required performance of extracorporeal medical diagnostic magnetic resonance equipment
TS EN 60601-2-36 Electrical medical equipment - Part 2-36: Specific features for the basic safety and required performance of the equipment used for the external and external fractures of the kidney and gallbladder
60601-2-41 / A1Electrical medical equipment - Part 2-41: Specific requirements for the basic safety and required performance of lighting fixtures used in surgical interventions and diagnostics
60601-2-41 / A1Electrical medical equipment - Part 2-41: Specific requirements for the basic safety and required performance of lighting fixtures used in surgical interventions and diagnostics
60601-2-41 / A1Electrical medical equipment - Part 2-41: Specific requirements for the basic safety and required performance of lighting fixtures used in surgical interventions and diagnostics
TS EN 60601-2-47 Electrical medical equipment - Part 2-47: Particular requirements concerning the essential safety and required performance of portable electrocardiograph systems
Electrical medical equipment - Characteristics of digital x-ray imaging devices - Part 62220-1: Determination of sensor quantum yield - Detectors used in radiographic imaging
TS EN 60601-2-37 / A1Electrical medical devices - Part 2-37: Specific requirements for the essential safety and required performance of ultrasonic medical diagnostic and imaging equipment
TS EN 60601-2-54 / A1Electrical medical equipment - Part 2-54: Particular requirements concerning the essential safety and required performance of x-ray equipment for radioscopy and radiography
TS EN 60601-2-62 Electrical medical equipment - Part 2-62: Specific requirements for the essential safety and required performance of high-intensity therapeutic ultrasound (HITU) equipment
TS EN 60601-2-63 Medical electrical equipment - Part 2-63: Specific requirements for the essential safety and necessary performance of the extra-oral x-ray equipment used in dentistry
TS EN 60601-2-64 Electrical medical equipment - Part 2-64: Specific features for the basic safety and required performance of light ion beam medical electrical equipment
TS EN 60601-2-68 Electrical medical equipment - Part 2-68: Specific features for the essential safety and required performance of X-ray based image guided radiotherapy equipment, light ion beam treatment equipment and radionuclide radiation treatment equipment used in conjunction with electron accelerators
TS EN 60627 Diagnostic x-ray imaging device - Characteristics of general-purpose and mammography-related anti-scatter gratings
TS EN 62570 Standard practice for safety marking of medical devices and other goods in a magnetic resonance environment
TS EN 62570 Standard practice for safety marking of medical devices and other goods in a magnetic resonance environment
TS EN 80601-2-58 Electrical medical equipment - Part 2-58: Specific features for basic safety and required performance of lens removal devices and vitrectomy devices for ophthalmic surgery
TS EN 80601-2-60 Medical electrical equipment - Part 2-60: Specific requirements for essential safety and necessary performance of dental equipment
TS EN 60601-2-8 Electrical medical equipment - Part 2-8: Specific requirements for essential safety and required performance of therapeutic x-ray equipment operating in the 10 kV to 1 MV range
TS EN 60601-2-16 Electrical medical devices - Part 2-16: Specific requirements for basic safety and required performance of hemodialysis, hemodiafiltration and hemofiltration devices
TS EN 60601-2-16 Electrical medical devices - Part 2-16: Specific requirements for basic safety and required performance of hemodialysis, hemodiafiltration and hemofiltration devices
TS EN 60601-1-12 Electrical medical equipment - Part 1-12: General rules for basic safety and required performance - Supplementary standard: Specification for medical electrical equipment and medical electrical systems used in the emergency medical service environment
TS EN 60601-2-11 Electrical medical equipment - Part 2-11: Particular requirements for basic safety and required performance of gamma ray therapy equipment
TS EN 60601-2-17 Electrical medical equipment - Part 2-17: Specific features for the essential safety and required performance of automatic controlled brachytherapy equipment
TS EN 62366-1 Medical devices - Part 1: Application of availability technique to medical devices
TS EN 80601-2-30 / A1Electrical medical equipment - Part 2-30: Specific features for the essential safety and essential performance of noninvasive automatic repeated blood pressure monitoring equipment
TS EN ISO 80369-20 Small binders for liquids and gases in health care applications - Part 20: Common test methods
TS EN ISO 12417-1 Cardiovascular implants and extracorporeal systems - Vascular device-pharmaceutical combined products - Part 1: General features
TS EN ISO 23500 Guidelines for the preparation and quality management of fluids used in hemodialysis and related treatments
TS EN ISO 18490 Non-Destructive Testing - Measurement of visual acuity of NDT personnel
TS EN ISO 11663 Quality of dialysis fluid for hemodialysis and related treatments
TS EN 60601-1 / A1 / ACElectrical medical equipment - Part 1: General rules for basic safety and required performance (IEC 60601-1: 2005 / A1: 2012 / Revision July 2014)
TS EN ISO 13958 Concentrated solutions for hemodialysis and hemodialysis-related treatments
TS EN ISO 13959 Properties of water used in hemodialysis and hemodialysis-related treatments
TS EN ISO 26722 Water treatment equipment for hemodialysis applications and related treatments
TS EN 60601-1 / A1 / ACElectrical medical equipment - Part 1: General rules for basic safety and required performance (IEC 60601-1: 2005 / A1: 2012 / Revision July 2014)
TS EN ISO 1135-4 Transfusion equipment for medical use - Part 4: Gravity-operated disposable transfusion sets
TS EN ISO 1135-5Transfusion equipment for medical use - Part 5: Disposable transfusion sets used with pressure infusion equipment
TS EN 60601-2-8 / A1Electrical medical equipment - Part 2-8: Particular requirements for the essential safety and required performance of therapeutic x-ray equipment operating in the 10 kV to 1 MV range
TS EN 60601-2-45 / A1Electrical medical equipment - Part 2-45: Particular requirements and safety requirements for the safety of mammographic x-ray equipment and mammographic stereotactic devices
TS EN 60601-2-33 / A2Electrical medical equipment - Part 2-33: Specific requirements for essential safety and required performance of extracorporeal medical diagnostic magnetic resonance equipment
Particular requirements for the basic safety and required performance of electron accelerators in the range 60601 MeV - 2 MeV: Part 1-2 Electrical medical equipment - Part 1-1
TS EN 60601-2-18 Electrical medical equipment - Part 2-18: Specific features for basic safety and required performance of endoscopic devices
TS EN 60601-2-49 Electrical medical equipment - Part 2-49: Specific features for basic safety and required performance of the multifunctional patient monitoring device
TS EN 60601-2-5 Electrical medical equipment - Part 2-5: Specific requirements for basic safety and required performance of ultrasonic physiotherapy equipment
TS EN 60601-2-23 Medical electrical equipment - Part 2-23: Key features for the basic safety and required performance of partial pressure monitoring devices through the skin
TS EN 62467-1 Electrical medical equipment - Dosimetric devices for brachytherapy - Part 1: Devices based on well-type ionization chambers
TS EN 62467-1 Electrical medical equipment - Dosimetric devices for brachytherapy - Part 1: Devices based on well-type ionization chambers
TS EN 60601-2-25 Medical electrical equipment - Part 2-25: Specific requirements for essential safety and required performance of electrocardiographs
TS EN 60601-2-25 Medical electrical equipment - Part 2-25: Specific requirements for essential safety and required performance of electrocardiographs
TS EN 62366-1 / AC Medical devices - Part 1: Application of availability technique to medical devices
tst EN 61223-3-5 Evaluation and routine tests in the medical imaging department - Part 3-5: Acceptance tests- Image performance for X-ray computed tomography (IEC 61223-3-5: 2004)
tst EN 61267 Medical diagnostic x-ray equipment - Radiation requirements for use in determining specifications (IEC 61267: 2005)
tst EN 60806 Determination of the largest symmetrical radiation field from a rotating anode x-ray tube for medical diagnosis
tst EN 60601-2-65 Electrical medical devices section 2-65: Particular requirements for basic safety and necessary performance of dental intra-oral X-Ray equipment (IEC 60601-2-65: 2012)
tst EN 60627 Diagnostic x-ray imaging device - Characteristics of general-purpose and mammography-related anti-scatter gratings (IEC 60627: 2013)
tst EN 60601-2-45 Electrical medical devices - Part 2-45: Particular requirements and performance for the safety of mammographic x-ray equipment and mammographic stereotactic devices (IEC 60601-2-45: 2011)
Electrical medical equipment - Part 60601-2: Particular requirements for the safety of mammographic x-ray equipment and mammographic stereotactic devices (IEC 45-1-2: 45)
tst EN 60601-2-33 Electrical medical equipment - Part 2-33: Specific requirements for the safety of extracorporeal medical diagnostic magnetic resonance equipment (IEC 60601-2-33: 2010)
Electrical medical equipment - Part 60601-2: Particular requirements for basic safety and required performance of medical diagnostic magnetic resonance equipment (IEC 33-1-2: 33 / 60601)
Electrical medical equipment - Part 60601-2: Specific features for the safety of extracorporeal medical diagnostic magnetic resonance equipment TS EN 33-11-2 / tst A33
Electrical medical equipment - Part 60601-2: Particular requirements for the essential safety and required performance of external medical diagnostic magnetic resonance equipment (IEC 33-2: 2: 33)
Electrical medical equipment - Part 60601-2: Specific requirements for basic safety and required performance of extracorporeal medical diagnostic magnetic resonance equipment TS EN 33-2-33
tst EN 62570 Standard practice for safety marking of medical devices and other goods in a magnetic resonance environment (IEC 62570: 2014)
tst EN 62570 Standard practice for safety marking of medical devices and other goods in a magnetic resonance environment (IEC 62570: 2014)
tst EN 62464-1 Magnetic resonance equipment for medical imaging - Part 1: Determination of the required image quality parameters (IEC 62464-1: 2007)
tst EN 60601-2-37 Electrical medical devices - Part 2-37: Specific requirements for the safety of ultrasonic medical diagnostic and imaging equipment (IEC 60601-2-37: 2007)
Electrical medical devices - Part 60601-2: Particular requirements for the essential safety and required performance of ultrasonic medical diagnostic and imaging equipment (IEC 37-1: 2: 37)
tst EN 60601-2-26 Electrical medical devices - Part 2-26: Specific properties for basic safety and required performance of electroencephalography devices (IEC 60601-2-26: 2012)
tst EN 60601-2-26 Electrical medical devices - Part 2-26: Specific requirements for the essential safety and required performance of electroencephalography devices (IEC 60601-2-26: 2012)
tst EN 60601-2-47 Electrical medical equipment - Part 2-47: Particular requirements relating to the essential safety and required performance of portable electrocardiograph systems (IEC 60601-2-47: 2012)
tst EN 60601-2-25 Medical electrical equipment - Part 2-25: Specific requirements for the essential safety and required performance of electrocardiographs (IEC 60601-2-25: 2011)
tst EN 60601-2-25 Medical electrical equipment - Part 2-25: Specific requirements for the essential safety and required performance of electrocardiographs (IEC 60601-2-25: 2011)
tst EN 80601-2-30 Electrical medical equipment - Part 2-30: Specific features for safety, including the required performance of noninvasive automatic repeat blood pressure monitoring equipment (IEC 80601-2-30: 2009 + Corrigendum 2010-01)
Electrical medical equipment - Part 80601-2: Particular requirements for the essential safety and required performance of noninvasive automatic repeated blood pressure monitoring equipment (IEC 30 / 1: 2)
tst EN 60601-2-10 Electrical medical equipment - Part 2-10: Specific requirements for essential safety and required performance of nerve and muscle stimulators (IEC 60601-2-10: 2012)
Electrical medical equipment - Part 60601-2: Specific requirements for the essential safety and required performance of extracorporeal medical diagnostic magnetic resonance equipment TS EN 33-2-2 / tstAC-33
EN ISO 80601-2-55 Electrical and medical equipment - Part 2-55: Specific requirements for basic safety and required performance of respiratory gas monitors (ISO 80601-2-55: 2011)
XBX-80601: Particular requirements for the basic performance and basic safety of anesthesia workstations (ISO 2-13-2: 13)
EN ISO 80601-2-12 Electrical and medical equipment - Part 2-12: Specific requirements for the safety of lung fans - Intensive care fans (ISO / IEC 80601-2-12: 2011)
tst EN 60601-2-24 Electrical medical devices - Part 2-24: Specific requirements for essential safety and required performance of infusion pumps and controllers (IEC 60601-2-24: 2012)
tst EN 60601-2-16 Electrical medical devices - Part 2-16: Particular requirements for essential safety and required performance of hemodialysis, hemodiafiltration and hemofiltration devices (IEC 60601-2-16: 2012)
tst EN 60601-2-16 Electrical medical devices - Part 2-16: Particular requirements for essential safety and required performance of hemodialysis, hemodiafiltration and hemofiltration devices (IEC 60601-2-16: 2012)
tst EN 60601-2-39 Electrical medical devices - Part 2-39: Particular requirements for the safety of peritoneal dialysis devices (IEC 60601-2-39: 2007)
tst EN 62464-2 Magnetic resonance equipment for medical imaging - Part 2: Classification criteria for pulse sequences (IEC 62464 2: 2010)
60601-2-37 / tst A11 Electrical medical devices - Part 2-37: Specific features for the safety of ultrasonic medical diagnostic and imaging equipment
tst EN 61157 Ultrasonic devices - used in medical diagnosis - Acoustic output declaration rules (IEC 61157: 2007)
TS EN 61157 / tst A1 Ultrasonic devices - used in medical diagnosis - Acoustic output declaration rules (IEC 61157: 2007 / A1: 2013)
Electrical equipment - Part 60601-2: Particular requirements for basic safety and performance of heart defibrillators (IEC 4-2-4: 60601)
Electrical medical equipment - Part 60601-2: Specific requirements for essential safety and required performance of extracorporeal medical diagnostic magnetic resonance equipment TS EN 33-2-2 / AC-33
TS EN ISO 13356 Surgical implants - Tetragonal zirconium oxide stabilized ceramic materials stabilized with yttrium oxide (Y-TZP)
tst EN ISO 5840-1 Cardiovascular implants - Heart valve prostheses - Part 1: General features
TS EN ISO 80601-2-61Electrical medical equipment - Part 2-61: Specific requirements for the essential performance and essential safety of the pulse oximetry equipment for
X-TRX 80601-2 61-2: Specific features for the required performance and basic safety of pulse oximetry equipment (ISO 61-80601-2: 61)
80601-2-12 / tst AC Electrical equipment - Part 2-12: Particular requirements for the safety of lung fans - Intensive care fans - Technical Correction
80601-2-12 / AC Electrical medical equipment - Part 2-12: Specific requirements for the safety of lung fans - Intensive care fans
Electrical medical devices - Part 60601-2: Particular features for the safety of peritoneal dialysis devices
Electrical medical devices - Part 60601-2: Particular features for the safety of peritoneal dialysis devices TS EN 39-11-2 / tst A39
tst EN 61847 Ultrasound-Surgical systems-Measurement and notification of basic output characteristics
tst EN 60601-2-57 Electrical medical equipment - Part 2-57: Specific requirements for basic safety and required performance of laser-free devices for treatment, diagnosis, imaging and cosmetic / anesthetic use
tst EN 60601-2-57 Electrical medical equipment - Part 2-57: Specific requirements for basic safety and required performance of laser-free devices for treatment, diagnosis, imaging and cosmetic / anesthetic use
tst EN 60601-2-22 Electrical medical devices - Part 2-22: Specific requirements for the safety of diagnostic and therapeutic laser devices (IEC 60601-2-22: 2007 + A1: 2012)
TS EN 60601-2-22 Electrical medical devices - Part 2-22: Specific features for the safety of diagnostic and therapeutic laser devices
EN ISO 81060-1 Non-Invasive Sphygmomanometer Section 1: General Specifications (ISO 81060-1: 2007)
TS EN ISO 81060-1 Non-Invasive Sphygmomanometer Section 1: General Features
TS EN ISO 8362-2 Injection containers and accessories - Part 2: Stoppers for injection vials
TS EN ISO 8362-1 / A1Injection cups and accessories - Part 1: Injection vials made of glass tubing
TS EN ISO 10079-1 Medical aspiration equipment - Section 1: Electrically operated aspiration equipment
TS EN 16128 Ophthalmic optics - Reference method for nickel release experiments of spectacle frames and sunglasses
TS EN 60601-1-2 Electrical and medical equipment - Part 1-2: General specifications for basic safety and performance - Complementary standard: Electromagnetic disturbances - Characteristics and tests
TS EN 62304 / A1 Medical device software - Software lifecycle processes
TS EN 61675-2 Radionuclide imaging devices - Characteristics and test conditions - Part 2: Gamma cameras for imaging with whole body and single photon emission computed tomography (SPECT)
TS EN ISO 8362-5 Injection containers and accessories - Part 5: Freeze-drying plugs for injection vials
TS EN ISO 80601-2-72Electrical medical equipment - Part 2-72: Specific requirements for the essential safety and required performance of ventilators for home patient care for ventilator-dependent patients
TS EN ISO 11810 Lasers and laser-related equipment - Classification and test method of laser resistance for surgical drapes and / or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition
TS 13702 Authorized Services - Devices Used in Dental Prosthesis Laboratory - Rules
TS EN ISO 8537 Insulin syringes - Disposable, sterile - with or without needles
TS 13713Authorized services - Medical imaging devices - Rules
TS EN ISO 5360 Anesthetic evaporators - Material-specific filling systems
TS EN ISO 14408 Trachea tubes designed for laser surgery - Features for marking and accompanying information
TS EN ISO 7396-1 Medical gas piping systems - Part 1: Compressed medical gases and piping systems for vacuum
TS EN ISO 11197 Feeding units for medical environments
TS ISO 5832-4 Surgical implants - Metallic materials - Section 4: Cobalt-Chromium-Molybdenum casting alloy
TS ISO 5832-5 Surgical implants - Metallic materials - Part 5: Formable cobalt-chromium-tungsten-nickel alloy
TS EN 62563-1 / A1 Electrical medical equipment - Medical imaging display systems - Part 1: Evaluation methods
TS EN 60601-2-44 / A2Electrical medical equipment - Part 2-44: Specific requirements for basic safety and required performance of X-ray equipment for computed tomography
TS EN ISO 10322-1 Ophthalmic optics - Semi-processed spectacle lenses - Part 1: Technical specifications for single and multifocal lenses
TS EN ISO 10322-2 Ophthalmic optics - Semi-processed spectacle lenses - Part 2: Technical specifications for lenses with increasing strength and decreasing strength
TS EN ISO 10685-2 Ophthalmic optics - Electronic catalog and identification of spectacle frames and sunglasses - Part 2: Business information (ISO 10685-2: 2016, Revised edition 2016-05-15)
TS EN ISO 7376Anesthesia and breathing equipment - Laryngoscopes for tracheal intubation
TS EN ISO 7376 Anesthesia and breathing equipment - Laryngoscopes for tracheal intubation (ISO 7376: 2009)
Tst EN ISO 7396-1 Medical gas piping systems - Part 1: Compressed medical gases and piping systems for vacuum (ISO 7396-1: 2016)
tst EN ISO 11197 Feed units for medical environments (ISO 11197: 2016)
TS EN ISO 10328 Prosthetics - Structural testing of lower limb prostheses - Requirements and test methods
TS EN ISO 22675 Prosthetics - Testing of ankle devices and foot units - Requirements and test methods
TS ISO 5832-1 Surgical implants - Metallic materials - Part 1: Machined stainless steel
TS EN 61303 / AC Electrical medical devices - Radionuclide calibration devices - Specific methods for performance definition
TS ISO 5832-12 / Cor 1Surgical implants - Metallic materials - Part 12: Formable cobalt - Chromium-Molybdenum alloy
TS ISO 5832-14 Surgical implants - Metallic materials - Part 14: Formable titanium 15-molybdenum 5-zirconium 3-aluminum alloy
TS ISO 12891-1 Retrieval and analysis of surgical implants - Part 1: Retrieval and handling
TS ISO 12891-2 Retraction and analysis of surgical implants - Part 2: Analysis of retracted surgical implants
TS EN ISO 7864 Disposable sterile hypodermic needles - Requirements and test methods
TS EN ISO 6009 Disposable hypodermic needles - Color coding for identification
TS EN ISO 9626 Stainless steel needle tubes used in the manufacture of medical devices - Requirements and test methods
TS EN ISO 14971 / D1Medical devices - Applying risk management to medical devices (ISO 14971: 2007; Revised edition 2007-10-01)
TS EN ISO 8536-13 Infusion equipment for medical use - Part 13: Disposable grade flow regulators with liquid contact
TS EN ISO 5361 Anesthesia and breathing equipment - Trachea tubes and fittings
TS EN ISO 5364 Anesthesia and breathing apparatus - Oropharyngeal tubes
TS EN ISO 5366 Anesthesia and breathing apparatus - Tracheostomy tubes and fittings
TS EN 60601-2-3 / A1Electrical medical equipment - Part 2-3: Specific requirements for basic safety and required performance of short-wave therapy equipment
60601-2-6 / A1Electrical medical equipment - Part 2-6: Specific requirements for basic safety and required performance of microwave treatment equipment
TS ISO 13779-1 Surgical implants - Hydroxyapatite - Part 1: Ceramic hydroxyapatite
TS ISO 7206-2 / A1 Surgical implants - Partial and full hip joint prostheses - Part 2: Movable surfaces made of metal, ceramic and plastic materials
TS ISO 5835 Surgical implants - Metal bone screws with hexagonal head groove, spherical bottom face, asymmetrical thread - Dimensions
TS ISO 5838-1 Surgical implants - Metal bone nails and wires - Part 1: General requirements
TS ISO 8536-12 Infusion equipment for medical use - Part 12: Control valves
TS ISO 8536-12 / A1 Infusion equipment for medical use - Part 12: Control valves - Modified 1
TS EN ISO 5832-3 Surgical implants - Metallic materials - Part 3: Formable titanium 6-Aluminum 4-Vanadium alloy
TS EN ISO 7153-1 Surgical instruments - Materials - Part 1: Metals
TS EN ISO 80601-2-56Electrical medical equipment - Part 2-56: Specific requirements for basic safety and required performance of clinical thermometers for body temperature measurement
TS EN ISO 80369-3 Small diameter fasteners for liquids and gases in health care applications - Part 3: Fasteners for enteral applications
TS EN 60601-1-3 / A11Electrical medical devices - Part 1-3: General requirements for basic safety and required performance - Supplementary standard: Radiation protection in diagnostic x-ray equipment
Electrical medical equipment - Part 60601-2: Specific requirements for basic safety and required performance of medical diagnostic magnetic resonance equipment TS EN 33-12-2 / A33
TS EN ISO 8871-5 Elastomeric parts for devices for parenteral and pharmaceutical use - Part 5: Functional requirements and tests
TS EN ISO 15223-1 Medical devices - Symbols to be used on medical device labels, labeling and information provided - Part 1: General requirements
TS ISO 6474-1 Surgical implants - Ceramic materials - Part 1: High purity alumina based ceramic materials
TS ISO 6474-2 Surgical implants - Ceramic materials - Part 2: Zirconia reinforced high purity alumina matrix based composite materials
TS EN ISO 21535 / A1 Non-active surgical implants - Joint implants - Specific features for hip joint implants - Modified 1
TS EN ISO 19054 / A1 Supporting rail systems for medical equipment
TS EN ISO 11381 Ophthalmic optics - Spectacle frames - Screw threads
TS EN ISO 10938 Ophthalmic optics - Chart indicators for visual acuity measurement - Printed, mirrored and electronic
TS ISO 5832-7 Surgical implants - Metallic materials - Part 7: Malleable and cold formed cobalt-chromium-nickel-molybdenum-iron alloy
TS ISO 7206-4 / A1 Surgical implants - Partial and full hip joint prostheses - Part 4: Determination of strength characteristics and performance of stem femoral components - Modified 1
TS EN 60601-2-44 / A2Electrical medical equipment - Part 2-44: Specific requirements for basic safety and required performance of X-ray equipment for computed tomography
TS EN ISO 10322-1 Ophthalmic optics - Semi-processed spectacle lenses - Part 1: Technical specifications for single and multifocal lenses
TS EN ISO 10322-2 Ophthalmic optics - Semi-processed spectacle lenses - Part 2: Technical specifications for lenses with increasing strength and decreasing strength
TS EN ISO 10685-2 Ophthalmic optics - Electronic catalog and identification of spectacle frames and sunglasses - Part 2: Business information (ISO 10685-2: 2016, Revised edition 2016-05-15)
TS EN ISO 7376 Anesthesia and respiration related equipment - Laryngoscopes for trachea intubation
TS EN ISO 7376 Anesthesia and breathing equipment - Laryngoscopes for tracheal intubation (ISO 7376: 2009)
Tst EN ISO 7396-1 Medical gas piping systems - Part 1: Compressed medical gases and piping systems for vacuum (ISO 7396-1: 2016)
tst EN ISO 11197 Feed units for medical environments (ISO 11197: 2016)
TS 12426Authorized services - Medical devices - Rules
TS 13703Special services - Medical devices - Rules
TS EN ISO 10328 Prosthetics - Structural testing of lower limb prostheses - Requirements and test methods
TS EN ISO 22675 Prosthetics - Testing of ankle devices and foot units - Requirements and test methods
TS ISO 5832-1 Surgical implants - Metallic materials - Part 1: Machined stainless steel
TS EN 61303 / AC Electrical medical devices - Radionuclide calibration devices - Specific methods for performance definition
TS ISO 5832-12 / Cor 1Surgical implants - Metallic materials - Part 12: Formable cobalt - Chromium-Molybdenum alloy
TS ISO 5832-14 Surgical implants - Metallic materials - Part 14: Formable titanium 15-molybdenum 5-zirconium 3-aluminum alloy
TS ISO 12891-1 Retrieval and analysis of surgical implants - Part 1: Retrieval and handling
TS ISO 12891-2 Retraction and analysis of surgical implants - Part 2: Analysis of retracted surgical implants
TS EN ISO 7864 Disposable sterile hypodermic needles - Requirements and test methods
TS EN ISO 6009 Disposable hypodermic needles - Color coding for identification
TS EN ISO 9626 Stainless steel needle tubes used in the manufacture of medical devices - Requirements and test methods
Medical devices - Applying risk management to medical devices (ISO 14971: 1; revised edition 14971-2007-2007)
TS EN ISO 8536-13 Infusion equipment for medical use - Part 13: Disposable grade flow regulators with liquid contact
TS EN ISO 5361 Anesthesia and breathing equipment - Trachea tubes and fittings
TS EN ISO 5366 Anesthesia and breathing apparatus - Oropharyngeal tubes
TS EN ISO 5366 Anesthesia and breathing apparatus - Tracheostomy tubes and fittings
TS EN 60601-2-3 / A1Electrical medical equipment - Part 2-3: Specific requirements for basic safety and required performance of short-wave therapy equipment
60601-2-6 / A1Electrical medical equipment - Part 2-6: Specific requirements for basic safety and required performance of microwave treatment equipment
TS ISO 13779-1 Surgical implants - Hydroxyapatite - Part 1: Ceramic hydroxyapatite
TS ISO 7206-2 / A1 Surgical implants - Partial and full hip joint prostheses - Part 2: Movable surfaces made of metal, ceramic and plastic materials
TS ISO 5835 Surgical implants - Metal bone screws with hexagonal head groove, spherical bottom face, asymmetrical thread - Dimensions
TS ISO 5838-1 Surgical implants - Metal bone nails and wires - Part 1: General requirements
TS ISO 8536-12 Infusion equipment for medical use - Part 12: Control valves
TS ISO 8536-12 / A1 Infusion equipment for medical use - Part 12: Control valves - Modified 1
TS EN ISO 5832-3 Surgical implants - Metallic materials - Part 3: Formable titanium 6-Aluminum 4-Vanadium alloy
TS EN ISO 7153-1 Surgical instruments - Materials - Part 1: Metals
TS EN ISO 80601-2-56Electrical medical equipment - Part 2-56: Specific requirements for basic safety and required performance of clinical thermometers for body temperature measurement
TS EN ISO 80369- Small diameter fasteners for liquids and gases in healthcare applications - Part 3: Fasteners for enteral applications
TS EN 60601-1-3 / A11Electrical medical devices - Part 1-3: General requirements for basic safety and required performance - Supplementary standard: Radiation protection in diagnostic x-ray equipment
Electrical medical equipment - Part 60601-2: Specific requirements for basic safety and required performance of medical diagnostic magnetic resonance equipment TS EN 33-12-2 / A33
TS EN ISO 8871-5 Elastomeric parts for devices for parenteral and pharmaceutical use - Part 5: Functional requirements and tests
TS EN ISO 15223-1 Medical devices - Symbols to be used on medical device labels, labeling and information provided - Part 1: General requirements
TS ISO 6474-1 Surgical implants - Ceramic materials - Part 1: High purity alumina based ceramic materials
TS ISO 6474-2 Surgical implants - Ceramic materials - Part 2: Zirconia reinforced high purity alumina matrix based composite materials
TS EN ISO 21535 / A1Active surgical implants - Joint implants - Specific features for hip joint implants - Modified 1
TS EN ISO 19054 / A1Supportive rail systems for medical equipment
TS EN ISO 11381 Ophthalmic optics - Spectacle frames - Screw threads
TS EN ISO 10938 Ophthalmic optics - Chart indicators for visual acuity measurement - Printed, mirrored and electronic
TS ISO 5832-7 Surgical implants - Metallic materials - Part 7: Malleable and cold formed cobalt-chromium-nickel-molybdenum-iron alloy
TS ISO 7206-4 / A1 Surgical implants - Partial and full hip joint prostheses - Part 4: Determination of strength characteristics and performance of stem femoral components - Modified 1
TS ISO 11418-5 Containers and accessories for pharmaceutical preparations - Part 5: Droppers
TS EN 60601-1 / AC Electrical medical equipment - Part 1: General rules for basic safety and performance required
TS EN 80369-5 / AC Small hole connectors for liquids and gases for healthcare applications - Part 5: Connectors for law enforcement inflation applications
TS EN ISO 407 Small gas cylinders-Portable-For the gases used in medicine, pin-coded yoke-type valve connections
Electrical medical equipment - Part 60601-2: Specific requirements for basic safety and required performance of medical diagnostic magnetic resonance equipment TS EN 33-12-2 / tst A33
Electrical medical equipment - Part 80601-2: Particular requirements for the basic safety and required performance of heating devices for the use of blankets, pillows and mattresses and for the use of medical heating devices in accordance with TS EN 35-1-2 / A35
Electrical medical equipment - Part 60601-2: Specific requirements for basic safety and required performance of baby phototherapy equipment TS EN 50-1-2 / A50
TS EN 60601-2-10 / A1Electrical medical equipment - Part 2-10: Specific requirements for basic safety and required performance of nerve and muscle stimulators
TS EN 60601-2-19 / A1Electrical medical equipment - Part 2-19: Specific requirements for basic safety and required performance of baby incubators
TS EN 60601-2-20 / A1Electrical medical equipment - Part 2-20: Specific requirements for basic safety and required performance of baby transport incubators
TS EN 60601-2-21 / A1Electrical medical equipment - Part 2-21: Specific requirements for basic safety and required performance of radiant baby heaters
Electrical medical equipment - Part 60601-2: Specific requirements for the essential safety and required performance of nerve and muscle stimulators (IEC 10-1-2: 10 / 60601)
TS EN ISO 15225 Medical devices - Quality management - Medical device naming data structure
TS EN 80369-5 Small diameter fasteners for liquids and gases in healthcare applications - Part 5: Fasteners for blood pressure applications
TS EN ISO 7199 Cardiovascular implants and artificial organs - Blood gas exchangers (oxygenator)
TS ISO 8536-6 Infusion equipment for medical use - Part 6: Freeze-drying plugs for infusion bottles
TS EN ISO 1135-3 Transfusion equipment for medical use - Part 3: Disposable blood collection kits
TS EN 50527-1 Procedure for the evaluation of electromagnetic fields to which workers with exposed active medical devices are exposed - Part 1: General
TS EN 50527-2-1 Procedure for the assessment of electromagnetic fields exposed to workers with active implantable medical devices - Part 2-1: Specific assessment for pacemaker workers
TS EN ISO 13485 / AC Medical devices - Quality management systems - Requirements for regulatory purposes
TS EN ISO 7198 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
Electrical medical equipment - Part 60601: General rules for basic safety and required performance (IEC 1-1: 1 / A60601: 1)
TS EN 60601-1-8 / A11Electrical medical equipment - Part 1-8: General requirements for basic safety and required performance - Supplementary standard: General requirements, tests and guidance for electrical medical equipment and warning systems in electrical medical systems
TS EN ISO 25539-1 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
Electrical medical equipment - Part 60601-1: General requirements for basic safety and required performance - Subsidiary standard: General requirements, tests and guidance for warning systems in electrical medical equipment and electrical medical systems
TS ISO 27427 Anesthesia and breathing equipment - Nebulizing systems and components
tst EN 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices
Medical devices - Part 62366: Application of usability engineering to medical devices TS EN 1-1 / tst ACT
tst EN ISO 1135-3 Transfusion equipment for medical use - Part 3: Disposable blood collection kits
tst EN ISO 1135-4 Transfusion equipment for medical use - Part 4: Disposable transfusion sets operating by gravity
tst EN ISO 11608-2 Pen injectors - for medical use - Specifications and test methods - Part 2: Needles
tst EN ISO 15223-1Medical devices - Symbols to be used on medical device labels, labeling and information to be provided - Part 1: General requirements
tst EN ISO 3826-2 Plastic collapsible bags for human blood and blood components - Part 2: Graphic symbols used on labels and operating instructions
tst EN ISO 3826-3Plastic collapsible bags for human blood and blood components - Part 3: Blood bag systems integrated with other components
tst EN ISO 5359 Anesthesia and respiratory equipment - Low pressure hose fittings for use with medical gases
tst EN ISO 5364 Anesthesia and breathing equipment - Oropharyngeal tubes
EN ISO 8185 Humidifiers for medical use - General characteristics for humidification systems
tst EN ISO 9626 Stainless steel needle tubes for medical devices - Requirements and test methods
tst ENV 737-6 Medical gas piping systems - Part 6: Dimensions and allocation of probes for compressed medical gases and vacuum end units
tst ISO 27427 Anesthesia and breathing equipment - Nebulizing systems and components
TS ISO 11418-1 Containers and accessories for pharmaceutical preparations - Part 1: Glass dropping bottles
TS ISO 11418-2 Containers and accessories for pharmaceutical preparations - Part 2: Glass vials with screw cap for syrups
TS ISO 11418-3 Containers and accessories for pharmaceutical preparations - Part 3: Screw neck glass bottles for solid and liquid dosage forms (veral)
TS ISO 11418-7 Containers and accessories for pharmaceutical preparations - Part 7: Screw neck bottles made of glass tubing for liquid dosage forms
Safety regulations of electrical equipment used in measurement, control and laboratory - Part 61010-2: Particular requirements for in vitro diagnostic equipment
TS ISO 11418-5 Containers and accessories for pharmaceutical preparations - Part 5: Droppers
TS EN 60601-1 / AC Electrical medical equipment - Part 1: General rules for basic safety and performance required
TS EN 80369-5 / AC Small hole connectors for liquids and gases for healthcare applications - Part 5: Connectors for law enforcement inflation applications
TS EN ISO 407 Small gas cylinders-Portable-For the gases used in medicine, pin-coded yoke-type valve connections
TS EN 794-3 + A2 Lung ventilators - part 3: Specific features for emergency use and patient transport ventilators
TS EN ISO 8612 Ophthalmic instruments - Tonometers
TS EN 1615 Disposable enteral feeding catheters, enteral administration kits and fasteners - Design and testing
TS EN 1616 Disposable sterile urinary system catheters
TS EN 1616 / A1 Disposable sterile urinary system catheters
TS prEN 1617: 1997 / T1 (Number modification, TS EN 1617) Modification of disposable sterile drainage catheters and ancillary equipment
Tst EN 1733 (Priority 6) Suction catheters - Used in the respiratory tract
Tst EN 1733 (Priority 6) Suction catheters - Used in the respiratory tract
TS EN 1820 + A1 Anesthetic reservoir balloon (iso 5362: 2000, modified)
TS 3521-2 EN 1707% 6 (luer) tapered conical fittings for syringes, needles and other specific medical equipment-Lock connections
TS 3521-1 EN 20594-1 / A1 Tapered fittings, conical 6 (luer) - For syringes, needles and other medical supplies used in medicine - Part 1: General specifications
TS EN ISO 26782 / ACAnesthesiology and breathing apparatus - Spirometers designed to measure difficult exhalation volumes over time in humans
TS EN ISO 3826-3 Plastic collapsible bags for human blood and blood components - Part 3: Blood bag systems integrated with other components
TS EN ISO 3826-2 Plastic collapsible bags for human blood and blood components - Part 2: Graphic symbols used on labels and operating instructions
TS EN ISO 7885 Dentistry - Needles for dentistry - Sterile - Disposable
tst EN ISO 7197 Neurosurgical implants - Sterile, disposable hydrocephalus shunts and components
TS EN ISO 7197 Neurosurgery related implants - Sterile, disposable hydrocephalus shunts and components
TS EN ISO 7885: 2010Dentals used in dentistry-Sterile-Disposable
TS EN ISO 7886-1 Syringes-Hypodermic-Disposable sterile section 1: Syringes-For manual use
TS EN ISO 7886-2 Syringes - Hypodermic - Disposable sterile - Part 2: For use with a power-driven syringe pump
TS EN ISO 7886-1 / T1 Syringes-Hypodermic-Disposable sterile section 1: Syringes-Amended for manual use 1
TS EN ISO 7944 Optical and optical instruments - Reference wavelengths
TS EN ISO 7998 Optics - Eye - Eyeglass frames - Equivalent term lists and recipes
TS EN ISO 8362-1 Injection containers and accessories - Part 1: Injection vials made of glass tubing
TS EN ISO 8429 Optics and optics - Ophthalmology - Graduated dial
TS EN ISO 8871-1 Elastomeric parts for devices for parenteral and pharmaceutical use - Part 1: Extractable substances in aqueous autoclaves
TS EN ISO 8872 Aluminum caps for transfusion, infusion and injection vials - General specifications and test methods
TS EN ISO 8980-2 Optics - Eye-related - Uncut, ready-to-use eyeglass lenses - Part 2: Technical specifications of improved power lenses
TS EN ISO 8980-5 Ophthalmic optics - Uncut finished eyeglass lenses - part 5: Minimum requirements for eyeglass lens surfaces reported to be wear resistant "
TS EN ISO 8980-1 / ACOptic - Eye-related - Uncut, ready-to-use eyeglass lenses - Part 1: Specifications of single and multifocal lenses
TS EN ISO 8980-4 Ophthalmic optics - Finished spectacle lenses ready for cutting - Part 4: Requirements and test methods for anti-reflective coatings
TS EN ISO 9170-1 Terminals for medical gas piping systems - Part 1: Compressed medical gases and end units for use in vacuum
TS EN ISO 9170-2 Terminals for medical gas piping systems - part 2: Terminals for anesthetic gas discharge systems
TS EN ISO 9342-1 Optical and optical instruments - Test lenses for calibration of focal meters - Part 1: Test lenses for focal meters used for measuring spectacle lenses
TS EN ISO 9342-2 Optical and optical instruments - Test lenses for calibrating focal meters - Part 2: Test lenses for focal meters used in measuring contact lenses "
TS EN ISO 9360-1 Anesthesia and breathing equipment - Temperature and humidity changers (IDs) - For humidification of breathing gases by humans - Section 1: Intds for use with minimum Tidal volumes of 250 ml
TS EN ISO 9360-2 Anesthesia and breathing equipment - Temperature and humidity changers (IDs) - For humidification of breathing gases by humans - Section 2: Inds for use in patients undergoing tracheostomy with a minimum TNC volume of 250
tst EN ISO 9363-1 Optical and optical instruments - Contact lenses - Determination of cytotoxicity of contact lens material - Part 1: Agar coating and inhibition of growth - Tests
tst EN ISO 9713 Neurosurgical implants - Self-closing intracranial aneurysm clamps (iso 9713: 2002)
TS EN ISO 9713 Neurosurgical implants - Self-closing intracranial aneurysm clamps
TS EN ISO 9801 Ophthalmic instruments - Test box lenses
Lung ventilators for medical use - Part 10651 - Specific features for operator-operated resuscitators
Lung ventilators for medical use - Particular requirements for basic safety and performance - Part 10651: Respiratory support devices for home care
TS ISO 10936-1 Optical and optical instruments - Operating microscopes - Part 1: Specifications and test methods
TS EN ISO 10939 Ophthalmic instruments - Slit lamp microscopes
TS EN ISO 10940 Ophthalmic Instruments - Fundus cameras
TS EN ISO 10942 Ophthalmic instruments - Direct ophthalmoscopes
TS EN ISO 11380 Optics and optics - ophthalmic optics - Templates
tst EN ISO 11608-4 Pen injectors - Part for medical use - 4: Electronic and electromechanical pen injectors - Specifications and test methods
TS EN ISO 11979-9 Ophthalmic implants - Interocular lenses - Blum 9: Multi-focus interocular lenses
tst EN 12006-2 + A1 Inactive (fixed) surgical implants - Specific rules for heart and vascular implants - Part 2: Vascular prostheses involving the heart valve canals
tst EN 12006-3 + A1 Inactive (fixed) surgical implants - Particular requirements for heart and vascular implants - Part 3: Endovascular devices
TS EN 12439 Rectal Catheters-Sterile Disposable
tst EN 12563 Fixed (inactive) surgical implants - Mobile implants - Particular requirements for mobile hip implants
TS EN ISO 12865 Ophthalmic instruments - Retinoscopes
TS EN ISO 12866 + AC Ophthalmic Instruments - Perimeters
TS EN ISO 12866 / A1 Ophthalmic instruments - Perimetric instruments
TS EN ISO 12867: Ophthalmic instruments - frames
TS EN 13014 / AC Connection of the gas sampling tubes to anesthesia and breathing equipment
tst EN 13221 High pressure flexible connections - used with medical gases
TS EN ISO 13230 Ophthalmic optics - Barcode specifications
Respiratory system filters for anesthesia and respiratory use - Part 23328: Salt test method for assessing filtration performance
Respiratory therapy equipment - Part 13544: Nebulizer systems and components
TS EN 13544-1 / tst A1Breathing therapy devices - Part 1: Nebulizer systems and components
Respiratory therapy devices - Part 13544: Piping system and fittings
Respiratory therapy devices - Part 13544: Air distribution devices
TS EN 13868 Catheters - Single lumen catheters and test methods for bending medical tubing
tst EN 13868 Catheters - Single lumen catheters and test methods for bending medical tubing
TS EN 13976-1: 2011 Rescue systems - Transport of incubators - Part 1: Interface requirements
TS EN 13976-2: 2011 Rescue systems - Incubators - Part 2: System features
TS EN 14139 Optical - Eyewear - Technical specifications for ready-to-wear glasses
TS EN 14348 Chemical disinfectants and antiseptics - Quantitative suspension assay for the evaluation of the mycobacterial killing efficacy of chemical disinfectants used in medicine including device disinfectants
tst EN ISO 14607 Inactive surgical implants - Breast implants - Specific features
TS EN ISO 14607 Inactive surgical implants - Breast implants - Specific features
TS EN ISO 15004-2 Ophthalmic instruments - Basic features and test methods - Part 2: Protection against light damage
TS EN ISO 15253 Ophthalmic optics and instruments - Optical devices for strengthening the weak image
TS EN ISO 15253 / AC Ophthalmic optics and instruments - Optical instruments for strengthening poor vision
TS EN ISO 15254 Ophthalmic optics and instruments - Electro-Optical instruments for strengthening poor visibility
TS EN 15333-1 Respiratory equipment - Open circuit, gas supply at hub level - Section 1: Device for flow
TS EN 15333-1 / AC Breathing apparatus - Open circuit, gas supply at hub level - Section 1: Equipment for flow
TS EN ISO 15752 Ophthalmic instruments - Endo illuminators - Basic rules and test methods for optical radiation safety
tst EN ISO 16061 Instruments used with inactive surgical implants - General features
tst EN ISO 16061 Instruments used with inactive surgical implants - General features
tst EN ISO 16061 Instruments used with inactive surgical implants - General features
TS EN ISO 16284 Ophthalmic optics-Information exchange on ophthalmic optics
Sleep apnea respiratory therapy - part 17510: Sleep apnea respiratory therapy equipment
TS EN ISO 17510-2 Respiratory therapy for sleep apnea - part 2: Masks and application accessories
TS EN ISO 18369-1 Optics - Eye-contact - Contact lenses - Part 1: Recommendations for terms, classification system and labeling specifications
TS EN ISO 18369-2 optics - Eye-related - Contact lenses - Part 2: Tolerances
Medical devices for the protection of oxygen and oxygen mixtures
TS EN ISO 21534 Inactive surgical implants - Joint implants - Specific features
TS EN ISO 21535 Inactive surgical implants - Joint implants - Specific features for hip joint implants
TS EN ISO 21536 Inactive surgical implants - Joint implants - Specific features for knee joint implants
TS EN ISO 21969 High pressure flexible fasteners for use with medical gas systems
TS EN ISO 21987 Ophthalmic instruments - Eyeglass lenses
TS EN ISO 23328-2 Respiratory system filters for anesthesia and respiratory use - Part 2: Non-filtering considerations
TS EN ISO 24157 Ophthalmic optics and instruments - Reporting conditions for the human eye
TSE ISO / TS 24348 Optical - Eye - Spectacle frames - Method for simulating the determination of wear and nickel release in metal and combined spectacle frames
tst EN ISO 25539-1 / AC Heart and vascular implants - Part 1: Vascular prostheses
tst EN ISO 25539-1 Heart and vascular implants - Part 1 vascular prostheses
tst EN ISO 25539-2 Heart and vascular implants-Section 2: Vascular stents
tst EN ISO 25539-2 / AC Cardiovascular implants-Endovascular devices-Part 2: Vascular stents
TS EN ISO 26782 Anesthesia and breathing equipment - Spirometers designed to measure time-dependent exhalation volumes in humans
TS EN 27740 / A1 Surgical instruments - Scalpels with removable head - Connection sizes
TS EN 27740 / AC Surgical instruments, removable head scalpels - Connection sizes
TS EN ISO 8362-3 Injection containers and accessories - part 3: Aluminum caps for injection vials
TS EN 45502-2-2 Active medical devices that can be implanted in the body - Part 2-2: Specific features for implantable active medical devices intended to treat bradyarrhythmia (implantable defibrillators)
TS EN 45502-2-3 Implantable active medical devices - Part 2-3: Particular requirements
TS EN 45502-2-1 Active implantable medical devices - Part 2-1: Specific features for implantable active medical devices (pacemakers) designed to treat bradyarrhythmia
TS EN 60336 Electrical medical equipment - X-ray tube equipment for medical diagnostics - Characteristics of focus spots
TS EN 60580 Electrical medical devices - Dose area multiplication meters
TS EN 60601-2-9 Electrical medical devices part 2: Particular requirements for the safety of patient contact dosimeters used in radiotherapy as an electrical connection with radiation detectors
TS EN 60601-1-3 Electrical medical devices section 1: General rules for safety - Part 1.3 standard for general diagnostic purposes for radiation protection in the x-ray device for diagnostic purposes
tst EN 60601-2-7 (Priority 7) Electrical medical devices section 2-7: Particular requirements for the safety of high-voltage generators of diagnostic x-ray generators
TS EN 60601-2-29 Electrical medical devices - Part 2-29: Particular requirements for the safety of radiotherapy simulators
TS EN 60601-1-9 Electrical medical equipment - Part 1-9: General specifications for basic safety and required performance - Supplementary standard: Specification for environmentally conscious design
TS EN 60601-2-44 Electrical medical devices - Part 2-44: Particular requirements for the safety of x-ray equipment in computed tomography
TS EN 60601-1-10 Electrical medical equipment - Part 1-10: General specifications for basic safety and required performance-Auxiliary standard: Specification for the development of physiological closed-loop controllers
Electrical medical devices - Part 60601-1: Basic safety and required performance requirements - Part 2: Complementary standard: Electromagnetic compatibility - Rules and tests TS EN 1-2-1 / tst A2
tst EN 60601-2-23 Electrical medical devices - Part 2-23: Particular features for the safety of the skin pressure monitoring devices including basic performance
TS EN 60601-2-40 Electrical medical equipment - Part 2- 40: Particular requirements for the safety of electromyographs and excited response equipment
TS EN 60601-2-41 Electrical medical equipment - Part 2-41: Specific requirements for the basic safety and required performance of lighting fixtures for surgical interventions and diagnostics
TS EN 60601-2-41 Electrical medical equipment - Part 2-41: Specific requirements for the basic safety and required performance of lighting fixtures for surgical interventions and diagnostics
TS EN 60601-2-41 Electrical medical equipment - Part 2-41: Specific requirements for the basic safety and required performance of lighting fixtures for surgical interventions and diagnostics
TS EN 60601-2-54 Medical electrical equipment - Part 2-54: Specific requirements relating to the basic safety and required performance of x-ray equipment for radioscopy and radiography
60601-2-43: Electrical devices 2010-Part 2-43: Particular requirements for the safety of x-ray equipment for interfering methods
TS EN 60601-2-31 Electrical medical equipment - Part 2-31: Specific requirements for the essential safety and required performance of external pacemakers with an internal power supply
TS EN 60601-2-37 Electrical medical devices - Part 2-37: Specific requirements for the safety of ultrasonic medical diagnostic and imaging equipment
TS EN 60601-2-39 Electrical medical devices - Part 2-39: Specific features for the safety of peritoneal dialysis devices
60601-1-3 / AC: 2010 Electrical medical devices section 1: General rules for safety - Part 1.3 standard for general diagnostic purposes for the protection of radiation in the x-ray device for diagnostic purposes
60601-2-57: 2011 Electrical medical equipment - Part 2-57: Specific requirements for the basic safety and required performance of laser-free devices for treatment, diagnosis, imaging and cosmetic / anesthetic use
Electrical medical equipment - Part 60601-2: Particular requirements for the essential safety and required performance of external pacemakers with internal power supply TS EN 31-2008-1: 2011 / A2
TS EN 60601-2-20 / A11 Electrical medical equipment - Part 2-20: Specific requirements for basic safety and required performance of baby transport incubators
60601-2-19 / A11 Electrical and medical equipment - Part 2-19: Specific requirements for the basic safety and performance of the infant incubators
TS EN 60976 Electrical medical device - Medical electron accelerators - Functional performance ICS (ec 60976: 1998) characteristic
TS EN 61157 Ultrasonic devices - used in medical diagnosis - Acoustic output declaration rules
TS EN 61168 Radiotherapy simulators - Functional performance characteristics
TS EN 61223-3-1 Routine testing and evaluation in medical imaging departments - Part 3 - 1: Acceptance tests - X for radiography and radioscopy systems - Imaging performance of the beam device
TS EN 61223-3-3 Routine testing and evaluation in medical imaging departments - Part 3 - 3: Acceptance experiments - Imaging performance of x-ray device for digital inference angiography (SCA)
TS EN 61223-3-4 Routine testing and evaluation in medical imaging departments - Part 3 - 4: Acceptance tests - Imaging performance of x-ray equipment used in dentistry
TS EN 61223-3-5 Evaluation and routine tests in the medical imaging department - Part 3-5: Acceptance tests- Image performance for X-ray computed tomography
TS EN 61223-2-4 Routine testing and evaluation in medical imaging departments - section 2- 4: Invariance tests - Printed cameras
TS EN 61223-2-5 Routine testing and evaluation in medical imaging departments- section 2-5: Invariance tests - Image display devices
TS EN 61223-2-6 Evaluation and routine tests in medical imaging departments - Invariance tests - Part 2-6: Imaging performance of computed tomography x-ray equipment
tst EN 61223-3-2 Routine testing and evaluation in medical imaging departments - Section 3 - 2: Acceptance tests - Imaging performance of mammography x-ray device
TS EN 61262-1 Characteristics of electrical medical devices- Electro-Optical x-ray image intensifiers section 1: Determination of input field size
TS EN 61262-3 The characteristics of electrical medical devices- Electro-Optical x-ray image intensifiers section 3: Determination of irradiation distribution and irregular illumination
TS EN 61262-4 Electrical medical devices - Electro - Optical x-ray image clarifiers - Part 4: Determination of image distortion
TS EN 61262-5 Electrical medical devices - Characteristics of electro-optical x-ray image clarifiers - Part 5: Determination of detector photon efficiency
TS EN 61262-6 Electrical medical devices - Characteristics of electro-optical x-ray image clarifiers - Part 6: Determination of the contrast ratio and the index of the glare
TS EN 61262-7 Electrical medical equipment-Electro-optical properties of X-ray image intensifiers-Part 7: Determination of modulation transfer function
TS EN 61266 Ultrasonic - Handheld doppler fetal heart beat detectors with probes - Performance characteristics and measurement and reporting methods
TS EN 61267 Medical diagnostic x-ray equipment - Radiation requirements for use in specification determination
TS EN 61303 Electrical medical devices - Radionuclide calibration devices - Specific methods for performance definition
TS EN 61676 Medical devices with electrics - Dosimetric instruments for non-invasive measurement of x-ray tube voltage in diagnostic radiology 24.04.2007
TS EN 61676 / A1 Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of x-ray tube
TS EN 61676 / A1 Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of x-ray tube
TS EN 61846 Ultrasonic pressure fracture of kidney stones and similar stones -Characteristics of fields
TS EN 61847 Ultrasound-Surgical systems-Measurement and notification of basic output characteristics
TS EN 62083 Electrical medical devices - Rules for the safety of radiotherapy treatment planning systems
62220-1-2 Electrical medical equipment - Characteristics of digital x-ray imaging devices - Part 1-2: Determination of sensor quantum yield-Detectors used in mammography
62220-1-3 Electrical medical equipment - Characteristics of digital x-ray imaging devices - Part 1-3: Determination of sensor quantum efficiency-Detectors used in dynamic imaging
TS EN 62274 Electrical medical equipment - Safety of radiotherapy registration and verification systems
TS EN 62304 Medical device software - Software life cycle processes
TS EN 62359: 2011 Ultrasonic - Ultrasonic field characterization - Test methods for the determination of thermal and mechanical indices of ultrasonic fields for medical diagnosis
TS EN 62494-1 Electrical medical devices -Digital x-Ray exposure systems index-Part 1: General radiography specifications and properties
TS EN 62563-1 Electrical medical equipment - Medical imaging display systems section 1: Evaluation methods
TS EN ISO 8362-7: 2010 Injection containers and accessories - Part 7: Injection vials made of non-overlapping aluminum plastic combinations with plastic parts
Transient breathing stop in sleep Breathing therapy in sleep-part 17510: Temporary breathing in sleep Breathing device in breathing