Health Technology Standards

We carry out audits and certification activities of the following standards by conducting audits that provide added value to our customers.

TS EN 61168 Radiotherapy simulators, functional performance characteristics

TS EN ISO 1797-2 Rotary dentistry equipment-Joints-Part 2: Plastic joints

TS EN 556-1 / AC Sterilization of medical devices - Specification for medical devices to be marked "sterile" - Part 1: Specifications for sterile medical devices

TS EN 556-1 / AC Sterilization of medical devices - Specification for medical devices to be marked as “sterile - - Part 1: Specifications of finally sterilized medical devices

TS EN 61223-2-4 Evaluation and routine testing in medical imaging departments-Section 2-4: Stability tests-Printing cameras

TS EN ISO 7488 Dental Amalgamators

TS EN 61262-2 Electrical medical devices- Electro-Optics x- Characteristics of the beam image intensifiers section 2: Determination of the conversion factorTS EN ISO 18778 Respiratory equipment - Neonatal monitors - Specific features

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

60601-2-52: 2010 / AC: 2011 Electrical medical equipment - Part 2-52: Specific requirements for basic safety and necessary performance of patient beds

Dentistry - Number coding system for rotating instruments - Part 6360: Figures TS EN ISO 2-2004: 1 / A2

80601-2 Electrical medical equipment - Part 55-2: Specific requirements for basic safety and performance of respiratory gas monitors

TS EN ISO 13408-6 / A1 Recommendation 6-Isolator systems for health care products manufactured under aseptic conditions

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

TS EN ISO 11140-1 Sterilization of healthcare equipment - Chemical indicators - Part 1: General properties

TS EN ISO 8536-10 Infusion equipment for medical use - Part 10: Accessories for disposable fluid pathways used in conjunction with pressure infusion equipment

Molecular in vitro diagnostic investigations - Characteristics of pre-examination procedures for FFPE tissue - Part 16827: Isolated DNA TSE CEN / TS 3-3

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 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 7396-2 Medical gas piping systems - Part 2: Anesthetic gas release systems

TS EN 16082 Airport and aviation security services

TS EN ISO 21647 / tst AC Electrical medical equipment - Specific requirements for the essential performance and essential safety of respiratory gas monitors

TS EN ISO 11143 Dental device - Amalgam separators

TS EN ISO 7711-2 Dentistry- Rotating diamond tools - Part 2: Discs

TS EN ISO 3823-2 Rotary instruments used in dentistry - Drills - Part 2: Finishing drills

Dentistry - Periodontal curettes, tooth caverns and excavators - Part 13397: Periodontal curettes - Gr-Tip

TS ISO 6474-1 Surgical implants - Ceramic materials - Part 1: High purity alumina based ceramic materials

TS EN ISO 14801 Dentistry - Implants - Dynamic loading test for intra-bone dental implants

TS EN 1640 Dentistry - Medical equipment for dentistry - Equipment

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 10993-18 Biological evaluation of medical devices - Part 18: Chemical properties of materials

Optics - Eye - Contact lenses - Part 18369: Recommendations for terms, classification system and labeling specifications TS EN ISO 1-1 / A1

TS EN ISO 12417-1 Cardiovascular implants and extracorporeal systems - Vascular device-pharmaceutical combined products - Part 1: General features

TS EN 60601-2-4 Electrical medical equipment - Part 2-4: Specific features for basic safety and significant performance of heart defibrillators

TS EN ISO 11979-3 Ophthalmic implants - Interocular lenses - Part 3: Mechanical properties and test methods

TS EN ISO 16256 Clinical, laboratory tests and in vitro diagnostic systems - Antimicrobial agents of fungi against fungi Reference method, including in vitro activity, infectious diseases

TS ISO 23600 Auxiliary products for the visually and hearing impaired - Pedestrian traffic lights - Audible warnings and sensible surfaces

TS EN 62570 Standard practice for safety marking of medical devices and other goods in a magnetic resonance environment

TS ISO 5832-14 Surgical implants - Metallic materials - Part 14: Formable titanium 15-molybdenum 5-zirconium 3-aluminum alloy

tst EN ISO 4049 Resin based outer fillers - used in dentistry

Respiratory therapy devices - Part 13544: Air distribution devices

TS ISO 23599 Auxiliary products for the visually impaired or visually impaired - Sensible walking surface markers

TS EN 1499 Chemical disinfectants and antiseptics - Hygienic hand washing agent - Test methods and properties (stage 2 / step 2)

TS EN 13612 Performance evaluation of extracorporeal medical diagnostic devices

TS EN ISO 13897 Dentistry - Amalgam capsules (ISO 13897: 2003)

794-3 + A2 Lung ventilators - Part 3: Specific features for emergency use and patient transport ventilators

TS EN ISO 8980-1 Optics - Eye-related - Uncut, ready-to-use eyeglass lenses - Part 1: Technical specifications of single and multifocal lenses

TS EN ISO 7405 Dentistry - Evaluation of the biocompatibility of medical devices used in dentistry (ISO 7405: 2008)

TS EN 1820 + A1 Anesthetic reservoir balloons (ISO 5362: 2000, mod.)

TS EN 1060-1 + A2 Non-invasive sphygmomanometer - Part 1: General features

TS EN 1500 Chemical disinfectants and antiseptics - Hygienic hand scrubbing agent - Test methods and properties (stage 2 / step 2)

TS EN ISO 21672-2 Dentistry - Periodontal probes - Part 2: Demonstration

TS EN 62563-1 / A1 Electrical medical equipment - Medical imaging display systems - Part 1: Evaluation methods

TS EN ISO 10322-2 Ophthalmic optics - Semi-processed spectacle lenses - Part 2: Technical specifications for lenses with increasing strength and decreasing strength

TS 6781 EN ISO 4135 Anesthesia and breathing equipment - Terms and recipes

tst EN ISO 8836 Suction catheters for use in the respiratory tract

TS EN ISO 22665 Ophthalmic optics and instruments - Tools for measuring eye axial distances

80601-2: Particular requirements for basic performance and basic safety of anesthesia workstations

18369-2: Ophthalmic optics - Contact lenses - Part 2012: Tolerances

TS EN 60601-2-44 / A2 Electrical medical equipment - Part 2-44: Specific requirements for essential safety and required performance of X-ray equipment for computed tomography

TS EN 12312-16 + A1 Aircraft ground support equipment - Special requirements - Part 16: Air start equipment

TS EN ISO 21535 Non-active surgical implants - Joint replacement - Specific features for hip replacement

TS EN ISO 23907 Protection against cutting injuries - Properties and test methods - Part 3: Cutting containers

TS ISO 5833 Surgical implants - Acrylic resin bone cement

TS EN ISO 9187-2 Injection equipment for medical use - Part 2: Single-point (TNK) ampoules (ISO 9187-2: 2010)

TS EN ISO 23500 Guidelines for the preparation and quality management of fluids used in hemodialysis and related treatments

TS EN ISO 16054 Surgical implants - Minimum data sets for surgical implants

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

TS EN ISO 14630 Inactive surgical implants - General features

Rotary instruments used in dentistry - Drills - Part 3823: Finishing drills - Modified 2 (ISO 1: 2: 1)

TSE ISO / IEC EN 19766 Information technology - Guidelines for the design of icons and symbols accessible to all users, including the elderly and disabled

TS EN 13641 Reducing or eliminating the risk of infection related to extracorporeal diagnostic reagents

TS EN 1865-5 Patient transport equipment for road ambulances - Part 5: Stretcher supports

TS EN 16686 Health measures for bone diseases

TS EN ISO 19429 Dentistry - Demonstration system for dental implants

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 12347 Biotechnology - Performance criteria for steam sterilizers and autoclaves

TS EN ISO 14937 Sterilization of health care products - General rules for the properties of the sterilizing agent and development, validation and routine control of the sterilization process for medical devices

TS EN ISO 7944: 1998 / AC Optical and optical instruments - Reference wavelengths

TS ISO 23599 / T1 Auxiliary products for the visually impaired or visually impaired

TSE ISO / IEC TR 19765 Information technology - Search for icons and symbols that provide access to functions and tools for improving the use of information technology products for the disabled and elderly

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 76 Packaging - For certain foods with ready packaging - Capacity of glass and metal containers

TS EN ISO 11990-1 Lasers and laser-related equipment - laser resistance determination in tracheal tubes - Part 1: Tracheal tube shaft

TS EN 1789 + A2 Medical vehicles and equipment - Road ambulances

TS EN ISO 10555-5 Intravenous catheters-Sterile, single-use-Part 5: Peripheral catheters with needle

TS EN 61303 / AC Electrical medical devices - Radionuclide calibration devices - Specific methods for performance definition

TS 6776 EN 13704 Chemical disinfectants - Quantitative suspension test to assess the sporicidal activity of chemical disinfectants used in food, industry, household and institutional areas - Test method and characteristics (stage 2, step 1)

TS EN ISO 14889 Optics - Eye - Eyewear lenses - Basic requirements for uncut, ready-to-use lenses

Respiratory therapy devices - Part 13544: Piping system and fittings

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

Lung ventilators for medical use - Part 10651 - Specific features for operator-operated resuscitators

TS EN ISO 11140-3 Sterilization of sanitary materials - Ethylene oxide - Part 3: Class 2 indicator systems for use in the Bowie and dick-type steam penetration test

TS EN ISO 11979-7 Optics - Eye-related - Implants - Intraocular lenses - Part 7: Clinical trials

TS EN 60601-1 / A12 Electrical medical equipment - Part 1: General rules for basic safety and required performance

TS EN ISO 7376 Anesthesia and breathing equipment - Laryngoscopes for tracheal intubation (ISO 7376: 2009)

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 10685-1 Electronic catalog and identification of ophthalmic optical eyeglass frames and sunglasses-Part 1: Product description and electronic catalog product ranking

TS EN 868-3 Packaging materials and systems for medical devices to be sterilized - Part 3: Paper bags (en 868-4) and paper and roll (en 868-5)

TS EN ISO 23908 Cutter injury protection - Characteristics and test methods - Disposable hypodermic needles, needles used for blood collection and catheters

TS EN ISO 3630-2 Root canal instruments for dentistry - Part 2: Expanders

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 16672 Ophthalmic implants - Ocular inner pads

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 60601-2-63 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 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 1060-3 + A2 Non-invasive sphygmomanometers - Part 3: Complementary features for electromechanical blood pressure measurement systems

TS EN ISO 10993-9 Biological evaluation of medical devices - Part 9: Preliminary study to identify and quantify potential degradation products

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 ISO 14160 Liquid chemical sterilization agents for disposable medical devices containing animal origin and similar substances - Rules for the specification, development, validity and routine control of the sterilization process for medical devices

tst EN ISO 20795-2 Dentistry-Base-based resins-Part 2: Orthodontic base resins (ISO 20795-2: 2013)

TS EN 1797 Cryogenic tanks - Gas, material compatibility

TS EN ISO 11607-1 Packaging for finally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

TS EN 60601-1-3 / A1 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 8598-1 Optics and optical instruments - Fucometers - Part 1: General-purpose instruments for measuring spectacle lenses

TS EN 61331-1 X-ray protective devices for diagnostic purposes in medicine Section 1: Determination of the attenuation properties of materials

TS EN ISO 10943 Ophthalmic instruments - Indirect ophthalmoscopes

TS EN ISO 10322-1 Ophthalmic optics - Semi-processed spectacle lenses - Part 1: Technical specifications for single and multifocal lenses

TS EN ISO 9680 Dentistry - Operation lights

TS EN 14820 Sample cups for collecting human venous blood samples - One time

TS EN ISO 17664 Sterilization of medical devices - Information provided by the manufacturer for the processing of re-sterilizable devices

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

tst EN ISO 225 Fasteners - Screws, deflections and nuts - Short designations and symbols

11979-8 Ophthalmic implants - Intraocular lenses - Part 8: Key features

TS EN 61675-1 Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emitting tomography devices

TS EN 455-2 Disposable medical gloves - Part 2: Rules and tests for physical properties

TS EN ISO 15883-4Washing machine disinfectants - Part 4: Specification and tests for chemical disinfecting washing machine disinfectants for heat-resistant endoscopes

TS EN 1865-4 Patient transport equipment for road ambulances - Part 4: Folding patient transport chair

TS EN ISO 8536-11 Infusion equipment for medical use - Part 11: Disposable infusion filters for use with pressure infusion equipment

TS EN ISO 16671 Ophthalmic implants - Washing solutions for ophthalmic surgery

60601-2-33 / A1 Electrical medical equipment - Part 2-33: Specific requirements for basic safety and required performance of medical diagnostic magnetic resonance equipment

XENUMX-62220-1Electrical medical equipment - Characteristics of digital x-ray imaging devices - Part 1-1: Determination of sensor quantum yield - Detectors used in radiographic imaging

TS EN 16081 + A1 Pressure Chambers - Special requirements for fire fighting systems - performance, application and testing

TS EN 1422 Medical sterilizers - Ethylene oxide sterilizers - Requirements and test methods

TSE CEN ISO / TS 13004 Sterilization of health care products - Radiation - verification of selected sterilization dose: VDmaxSD Method

TS EN ISO 18778 Breathing equipment - Newborn monitors - Specific features

TS EN ISO 10993-18 Biological evaluation of medical devices - Part 18: Chemical properties of materials

TS EN ISO 19980 Ophthalmic Instruments - Corneal topography

TS EN 80601-2-60 Medical electrical equipment - Part 2-60: Specific requirements for essential safety and necessary performance of dental equipment

10993-1 / AC: Biological evaluation of medical devices - Part 2010: Evaluation and testing

TS EN ISO 3826-1 Plastic collapsible bags for human blood and blood components - Part 1: Conventional blood bags

TS ISO 7176-28 Wheelchairs - Part 28: Rules and test methods for stair climbing / climbing devices

TS EN 1499 Chemical disinfectants and antiseptics - Hygienic hand washing agent - Test method and requirements (Phase 2 / Step 2)

TS 12576 Urban roads - Design rules for structural measures and markings for accessibility at sidewalk and pedestrian crossings

TS EN 12182 Auxiliary products for people with disabilities - General specifications and test methods

TS EN ISO 10993-3 Biological assessment of medical devices - Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity

TS EN ISO 26722 Water treatment equipment for hemodialysis applications and related treatments

Molecular in vitro diagnostic investigations - Features of pre-examination procedures for venous whole blood - Part 16835: Isolated genomic DNA

TS EN ISO 8598-1 Optics and optical instruments - Fucometers - Part 1: General-purpose instruments for measuring spectacle lenses

TS EN 61331-1 X-ray protective devices for diagnostic purposes in medicine Section 1: Determination of the attenuation properties of materials

TS EN 62353 Electrical medical equipment - Retest and test after repair of electrical medical equipment

tst EN 1865-1 + A1 Patient transport equipment for road ambulances - Part 1: General stretcher systems and patient transport equipment

TS EN 60601-1-3 / A1 / 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 60601-2-43 / AC Electrical medical devices - Part 2-43: Particular requirements for the safety of x-ray equipment for interventions

TS EN 14079 Inactive medical devices - Performance characteristics and test methods for hydrophilic cotton gauze and hydrophilic cotton and viscose gauze

TS EN ISO 8362-6 Injection containers and accessories-Part 6: Caps for injection vials made of aluminum-plastic connections

TS EN 61331-2 X-ray protection devices for medical diagnosis - Part 2: Translucent protective plates

TS EN ISO 22675 Prosthetics - Testing of ankle devices and foot units - Requirements and test methods

TSE CEN / TS 16826-1 Molecular in vitro diagnostic investigations - Properties of preliminary examination procedures for snap frozen tissue - Part 1: Isolated RNA

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 ISO 17254 Dentistry - Helical springs for orthodontics

Electrical medical equipment - Part 60601: General rules for basic safety and required performance (IEC 1-1: 1 / A60601: 1 / Correction July 2005)

TS EN ISO 13116 Dentistry - Test method for determining the radio-opacity of materials

TS EN 16372 Cosmetic surgery services

TS EN ISO 8624 / A1 Ophthalmic optics - Spectacle frames - Measuring system, terms and descriptions

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 60601-2-52 / A1 Electrical medical equipment - Part 2-52: Specific features for basic safety and necessary performance of patient beds

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

TSE CEN ISO / TS 22367 Medical laboratories - Reduction of errors through risk management and continuous improvement (including ISO / TS 22367: 2008, Correction 1: 2009)

TS EN 285 Sterilization - Steam autoclaves - Large autoclaves

TS EN 62467-1 Electrical medical equipment - Dosimetric devices for brachytherapy - Part 1: Devices based on well-type ionization chambers

TS EN ISO 3826-4 Plastic collapsible bags for human blood and blood components - Part 4: Apheresis blood bag systems integrated with other components

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 41-1-2 / A41

TS ISO 12891-2 Retraction and analysis of surgical implants - Part 2: Analysis of retracted surgical implants

TS EN ISO 9680 Dentistry - Operation lights

TS ISO 6474-1 Surgical implants - Ceramic materials - Part 1: High purity alumina based ceramic materials

TS EN ISO 14801 Dentistry - Implants - Dynamic loading test for intra-bone dental implants

TS EN 61262-2 Electrical medical devices - Electro-Optics x- Characteristics of the image intensifiers section 2: Determination of the conversion factor

TS EN 60627 Diagnostic x-ray imaging device - Characteristics of general-purpose and mammography-related anti-scatter gratings

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 ISO 15854 Dentistry - Casting and base plate waxes

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 7405 / A1 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Annex 1: Positive control material

TS EN ISO 10938 Ophthalmic optics - Chart indicators for visual acuity measurement - Printed, mirrored and electronic 09.12.2016 11.040.70

TS EN ISO 22794 Dentistry - Implant materials used in bone filling in oral and facial surgery -Technical file content

TS EN 14079 Inactive medical devices - Performance characteristics and test methods for hydrophilic cotton gauze and hydrophilic cotton and viscose gauze

TS EN ISO 8536-2 Infusion equipment for medical use - Part 2: Caps for infusion bottles

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)

TS EN 1639 Dentistry-Medical instruments used in dentistry-Instruments

TS EN ISO 11608-5 Pen injectors - for medical use - Specifications and test methods - Part 5: Automatic functions

TS EN ISO 8871-5 Elastomeric parts for devices for parenteral and pharmaceutical use - Part 5: Functional requirements and tests

TS EN ISO 11985 Optics - Eye - Contact lenses - Aging by exposure to UV and visible radiation (in vitro method)

TS EN ISO 21536 Inactive surgical implants - Joint implants - Specific features for knee joint implants

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 7864 Disposable sterile hypodermic needles - Requirements and test methods

TS EN ISO 6009 Disposable hypodermic needles - Color coding for identification

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 ISO 5356-1 Anesthesia and breathing equipment - Tapered fasteners - Section 1: Cones and sockets

TS EN ISO 19054 / A1 Supporting rail systems for medical equipment

TS EN ISO 14729 Optics - Eye care - Contact lens care products - Microbiological rules and test methods for hygienic systems and products

Electrical medical equipment - Part 60601: General rules for basic safety and required performance (IEC 1-1: 1 / A60601: 1 / Correction July 2005)

TS EN 13641 Reducing or eliminating the risk of infection related to extracorporeal diagnostic reagents

TS EN 13726-6 Inactive medical devices - Test methods for primary wound closures - Part 6: Odor control

TS EN ISO 13504 Dentistry - general requirements for dental implant placement and treatment instruments and related accessories

Breathing system filters for inhalation and anesthesia use - Part 23328: Non-filtration properties

TS EN ISO 8980-3 Ophthalmic optics - Uncut glasses lenses - Part 3: Permeability characteristics and test methods

TSE ISO / IEC EN 19766 Information technology - Guidelines for the design of icons and symbols accessible to all users, including the elderly and disabled

TS EN 1641 Dentistry-Medical equipment used in dentistry-Materials

Optics - Eye-related implants - Intraocular lenses - Part 11979: Labeling and information TS EN ISO 4-2008: 1 / A2012: 4

TS EN 1041 + A1 Information provided by medical device manufacturers

TS EN 13718-2 Medical instruments and equipment - Air ambulances - Part 2: Technical and operating rules for air ambulances

TS EN ISO 11381 Ophthalmic optics - Spectacle frames - Screw threads

TS EN 60601-2-25 Medical electrical equipment - Part 2-25: Specific requirements for essential safety and required performance of electrocardiographs

TS EN ISO 7944: 1998 / AC Optical and optical instruments - Reference wavelengths

TSE CEN ISO / TS 22367 Medical laboratories - Reducing errors through risk management and continuous improvement

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 22870 Bedside testers (POCT) - Requirements for quality and competence

TS EN ISO 21535 / A1 Non-active surgical implants - Joint implants - Specific features for hip joint implants - Modified 1

TS EN ISO 7493 Dental stool

TS EN ISO 13017 Magnetic attachments used in dentistry

S EN 60601-1-6 Electrical medical equipment - Part 1-6: General rules for basic safety and required performance - Supplementary 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 62489-1 Electroacoustic - Sound frequency induction circuit systems for assisted hearing - Part 1: Performance characteristics and measurement methods of system components

TS EN ISO 14457 Dentistry - Hand tools and motors

TS EN 12183 Wheelchairs - Hand driven - Features and test methods

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

TS EN 60601-2-19 / A1Electrical medical equipment - Part 2-19: Specific requirements for basic safety and required performance of baby incubators

TS EN 60601-2-18 Electrical medical equipment - Part 2-18: Specific features for basic safety and required performance of endoscopic devices

Electrical medical equipment - Part 60601-2: Specific requirements for basic safety and required performance of baby phototherapy equipment TS EN 50-1-2 / A50

TSE CEN ISO / TR 22411: 2011 iso / ic guide to products and services that meet the needs of the elderly and the disabled Ergonomics data and guidelines for the implementation of 71

Optics - Eye implants - Intraocular lenses - Part 11979: Phakic intraocular lenses (ISO 10-1: 10 / Amd 11979: 10)

TS EN 1618 Catheters other than intravenous catheters - Test methods for common properties

S EN 60601-2-49 Electrical medical equipment - Part 2-49: Specific features for basic safety and required performance of the multifunction patient monitoring device

TS EN 80369-5 Small diameter fasteners for liquids and gases in healthcare applications - Part 5: Fasteners for blood pressure applications

TS EN ISO 8980-1 Optics - Eye-related - Uncut, ready-to-use eyeglass lenses - Part 1: Technical specifications of single and multifocal lenses

TS ISO 23600 Auxiliary products for the visually impaired and visually impaired - Audible and audible signals for pedestrian traffic lights

ISO EN ISO 8536-4 / A1 Infusion equipment for medical use - Part 4: Disposable infusion sets with gravity effect (ISO 8536-4: 2010 / Amended 1: 2013)

TS EN ISO 80369-3 Small diameter fasteners for liquids and gases in health care applications - Part 3: Fasteners for enteral applications

TS EN ISO 7153-1 Surgical instruments - Materials - Part 1: Metals 09.12.2016 11.040.30

TS EN 60806 Determination of the largest symmetrical radiation field from a rotating anode x-ray tube for medical diagnosis

TS EN ISO 8185 Humidifiers for medical use - General features for humidification systems

TS EN ISO 15883-3 Washer-Disinfectors - Part 2: Surgical instruments, anesthetic equipment, bowls, plates, receivers, instruments, glassware, etc. disinfectants for thermal disinfection

TS EN ISO 15883-2 Washer-Disinfectors - Part 2: Surgical instruments, anesthetic equipment, bowls, plates, receivers, instruments, glassware, etc. disinfectants for thermal disinfection

TS EN ISO 5356-2 Anesthetic and respiratory equipment - Tapered fittings - Part 2: Weight-bearing fasteners with screw heads

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 16872 Homeopathy qualified doctors (MDQH) - Homeopathy qualified doctors

TS EN 60601-2-10 / A1 Electrical medical equipment - Part 2-10: Specific requirements for basic safety and required performance of nerve and muscle stimulators

TS 3521-1 EN 20594-1Conical fittings% 6 (luer) syringes used in tapered medicine syringes needles and other medical supplies section 1-General specifications

TS EN 1617 (Former no: TS prEN 1617) Disposable sterile drainage catheters and ancillary equipment

TS EN 81-40 Elevators - Safety regulations for construction and installation - Special applications for passenger and freight elevators - Part 40: Escalators and inclined lifts for passengers with reduced mobility

TS EN ISO 21649 Needle-free syringes for medical use - Specifications and test methods

TS EN ISO 10993-17 Biological evaluation of medical devices - Part 17: Determination of permissible limits for permeable substances

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 15798 Ophthalmic Implants - Ophthalmic Visco Surgical Instruments

TS EN ISO 21533 / AC Dentistry - Reusable cartridge syringes for intra-ligament injections

Respiratory therapy devices - Part 13544: Air distribution devices

TS ISO 23599 Auxiliary products for the visually impaired or visually impaired - Sensible walking surface markers

TS EN 14204 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobacterial killing of chemical disinfectants used in veterinary devices - Test method and requirements (step 2, step 1)

TS EN ISO 21534 Inactive surgical implants - Joint replacement - Specific features

TS EN ISO 27020 Dentistry - reagents and tubes for use in orthodontics

TS EN 13612 Performance evaluation of extracorporeal medical diagnostic devices

TS EN 14563 Chemical disinfectants and aantiseptics - Quantitative carrier assay for the evaluation of mycobacteric or tuberculocide activity of chemical disinfectants and antiseptics used in medical instruments

TS EN ISO 15883-1 Washer-Disinfectors - Part 1: General specifications, terms and definitions and tests

TS EN ISO 24500 Ergonomics - Accessible design - Auditory signals for consumer products

Pressure regulators for use with medical gases - Section 10524: Integrated pressure regulators with cylinder valves

TS EN ISO 11607-2 Packaging for finally sterilized medical devices - Part 2: Validation features for forming, sealing and assembly processes

TS EN ISO 10993-13 Biological evaluation of medical devices - Part 13: Identification and quantification of decomposition products of medical devices made of polymer

TS EN ISO 11987: 2012 Ophthalmic optics - Contact lenses - Determination of shelf life

TS EN 16224 + A1 Providing health care with chiropractic method

TS EN ISO 1135-4 Transfusion equipment for medical use - Part 4: Gravity-operated disposable transfusion sets

TS ISO 5832-7 Surgical implants - Metallic materials - Part 7: Malleable and cold formed cobalt-chromium-nickel-molybdenum-iron alloy

Electrical medical equipment - Part 80601-2: Specific requirements for the basic safety and required performance of heating devices for the use of blankets, pillows and mattresses and for the purpose of heating in medical use TS TS EN 35-2-35

TS EN ISO 15883-4 Washing machine disinfectants - Part 4: Specifications and tests for chemical disinfecting washing machine disinfectants for heat-resistant endoscopes

TS EN ISO 10993-10 Biological evaluation of medical devices - Part 10: Irritation and delayed type hypersensitivity tests

Pressure regulators for medical gases - Section 10524: Pressure regulators and flow fast pressure regulators

TS EN 13731 Lift cushion systems for fire and rescue services - Safety and performance features

TS EN ISO 9687 Dentistry - Graphic symbols for dental equipment

TS EN 1865-2 + A1 Patient transport equipment for road ambulances - Part 2: Electric stretcher

TS EN ISO 14161 Sterilization of health care products - Bionic indicators - Guide for use selection and interpretation of results

TS EN ISO 9626 Stainless steel needle tubes used in the manufacture of medical devices - Requirements and test methods

Electrical medical devices - Part 60601-1: General requirements for basic safety and required performance - Subsidiary standard: Radiation protection in diagnostic x-ray equipment - TS EN 3-11-1 / A3

TS ISO 6474-2 Surgical implants - Ceramic materials - Part 2: Zirconia reinforced high purity alumina matrix based composite materials

TS EN ISO 11140-4 Sterilization of sanitary products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the bowie and dick-type test for the detection of vapor permeability

60601-2-33 / A2 Electrical medical equipment - Part 2-33: Specific requirements for essential safety and required performance of extracorporeal medical diagnostic magnetic resonance equipment

Section 60601-2-20 / A1 Electrical and medical equipment - Part 2-20: Specific requirements for the basic safety and performance of infant transport incubators

TS EN 15927 Businesses - Served by hearing aid specialists

Electrical medical devices - Part 60601 -2: Particular requirements for the safety of X-ray equipment in computed tomography: TS 44-2009-1: 2 / A44

Packaging of medical devices - Finally sterilized - Part 11607: Conditions for validation for forming, sealing and joining processes (ISO 2-1: 2 / Amendment 11607: 2) 2006 1

TS EN 455-2 Disposable medical gloves - Part 2: Rules and tests for physical properties

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 60601-2-62 Electrical medical equipment - Part 2-62: Specific requirements for the essential safety and required performance of high-intensity therapeutic ultrasound (HITU) equipment

Electrical medical equipment - Part 80601-2: Specific features for the essential safety and essential performance of noninvasive automatic repeated blood pressure monitoring equipment TS EN 30-1-2 / A30

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

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 ISO 7176-26 Wheelchairs - Part 26: Glossary

TS EN ISO 15883-3 Washer-disinfectors - Part 3: Containers for human waste - Specifications and tests for washer-disinfectors applying thermal disinfection

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)

Packaging of medical devices - Finally sterilized - Part 11607: Specifications for materials, sterile barrier systems and packaging systems (ISO 1-1: 1 / Amendment 11607: 1) TS EN ISO 2006-1 / A2014

tst EN ISO 11135 Sterilization of health products - Ethylene oxide - Requirements for the development, validation and routine control of the sterilization process of medical devices (ISO 11135: 2014)

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

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)

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

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)

TS EN ISO 11117 Gas cylinders - Valve protection caps and valve housings - Design, construction and testing

TS EN 1865-3 + A1 Patient transport equipment for road ambulances - Part 3: Heavy duty stretcher

TS EN ISO 10993-2 Biological evaluation of medical devices - Part 2: Animal health characteristics

TS EN ISO 6876 Dental root canal filling materials used in dentistry

TS EN 12184 Electrically driven wheelchairs - Scooters and chargers - Characteristics and test methods

tst EN 285 Sterilization - Steam autoclaves - Large autoclaves

TS EN ISO 13897 Dentistry - Amalgam capsules (ISO 13897: 2003)

TS EN 60118-7 Electroacoustic - Hearing aids - part 7: Measurement of performance characteristics of hearing aids for quality assurance purposes in production, supply and distribution

80601-2 Electrical medical equipment - Section 61-2: The essential performance and essential safety of the pulse oximetry equipment

TS EN ISO 10993-12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

TS ISO 8009 Mechanical contraceptive devices - Reusable contraceptive diaphragms made of natural and silicone rubber - Requirements and tests

ISO EN 15883-1 / A1 Washer-disinfectors - Part 1: General specifications, terms, descriptions and experiments (ISO 15883-1: 2006 / Amended 1: 2014)

TS EN 285 Sterilization - Steam autoclaves - Large autoclaves

TS EN 62467-1 Electrical medical equipment - Dosimetric devices for brachytherapy - Part 1: Devices based on well-type ionization chambers

TS EN ISO 9187-2 Injection equipment for medical use - Part 2: Single-point (opc) ampoules

tst EN ISO 16635-1 Dentistry - Rubber dam technique used in dentistry - Part 1: Hole punch (ISO 16635-1: 2013)

tst EN ISO 11979-10 Optics - Eye implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-10: 2006)

TS EN ISO 15225 Medical devices - Quality management - Medical device naming data structure

TS EN ISO 11737-2 Sterilization of medical devices - Microbiological methods - Part 2: Sterilization tests for the validity of a sterilization process

TS EN ISO 11608-3 Pen injectors - for medical use - Specifications and test methods - Part 3: Ready-made containers

TS EN ISO 11137-3 Sterilization of sanitary products - Radiation - Part 3: Guidelines on dosimetric issues

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 27740 Surgical instruments, removable head scalpels - Connection sizes

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

TS EN 868-10 Packaging for medical devices for final sterilization - Part 10: Adhesive coated nonwoven polyolefin materials - Requirements and test methods

TS EN ISO 8871-3 Elastomeric parts for devices for parenteral and pharmaceutical use - Part 3: Determination of the number of particles released

10079-3 Medical aspiration equipment - Part 3: aspiration equipment supplied by vacuum or positive pressure source (ISO 10079-3: 2014)

TS ISO 5832-9 Surgical implants - Metallic materials - Part 9: Formable high nitrogen stainless steel

TS EN 61157 / tst A1 Ultrasonic devices - used in medical diagnosis - Acoustic output declaration rules (IEC 61157: 2007 / A1: 2013)

X-TRX 80601-2 61-2: Specific features for the required performance and basic safety of pulse oximetry equipment (ISO 61-80601-2: 61)

Electrical medical equipment - Part 80601-2: Specific features for the safety of lung ventilators - Intensive care ventilators - Technical correction (ISO 12-2-12: 80601 / Cor 2: 12: 2011)

TS EN ISO 8980-1 / AC Optics - Eye-related - Uncut, ready-to-use eyeglass lenses - Part 1: Technical specifications of single and multifocal lenses

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 EN 868-3 Packaging materials and systems for medical devices to be sterilized - Part 3: Paper bags (en 868-4) and paper and roll (en 868-5)

TS EN 14683 Medical face masks - Requirements and test methods

TS EN 61223-2-5 Evaluation and routine trial in medical imaging departments-Section 2-5: Stability tests-Display screens

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 60601-2-47 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)

TS EN ISO 11980 Ophthalmic optics - Contact lenses and contact lens care products - Guide for clinical examinations

60601-2-8-1 / A2 Electrical medical equipment - Part 8-10: Specific requirements for essential safety and required performance of therapeutic x-ray equipment operating in the 1 kV to XNUMX MV range

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

60601-2-21 / A1 Electrical and medical equipment - Part 2-21: Specific requirements for the basic safety and performance of radiant baby heaters

TS EN 1642 Dentistry - Medical equipment for dentistry - Implants

TS EN 61205 Ultrasonic, dental dentistry, measurement and specification of output properties

TS EN 61266 Ultrasonic-Doppler fetal heartbeat detectors with hand probes-Performance characteristics and measurement methods and reporting

TS EN ISO 7494-1 Dentistry - Dental units - Part 1: General rules and test methods

TS EN ISO 15098-2 Preseller - Used in Dentistry - Part 2: Meriam types

TS EN ISO 14937 Sterilization of sanitary materials - General requirements for the specification of a sterilizer and the development, validation and routine control of a sterilization process for medical devices

TS EN 50527-1 Procedure for the evaluation of electromagnetic fields to which workers with exposed active medical devices are exposed - Part 1: General

tst EN ISO 16443 Dentistry-Terms for dental implant systems and related procedures (ISO 16443: 2014)

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 455-2 + A1 Medical gloves - Disposable - Part 2: Tests for properties and physical properties

TS EN 60601-2-43 / AC Electrical medical devices - Part 2-43: Particular requirements for the safety of x-ray equipment for interventions

tst EN ISO 20795-2 Dentistry-Base-based resins-Part 2: Orthodontic base resins (ISO 20795-2: 2013)

80601-2: Particular requirements for the basic safety and performance of ventilators for ventilator-dependent patients at home

TS EN ISO 7396-1 Medical gas piping systems - Part 1: Compressed medical gases and piping systems for vacuum

TS ISO 5832-5 Surgical implants - Metallic materials - Part 5: Formable cobalt-chromium-tungsten-nickel alloy

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 ISO 8980-2 / AC Optics - Eye-related - Uncut, ready-to-use eyeglass lenses - Part 2: Specifications for improved power lenses

TS EN ISO 15098-3 Preseller - Used in Dentistry - Part 3: College types

TS EN ISO 7199 Cardiovascular implants and artificial organs - Blood gas exchangers (oxygenator)

TS ISO 7176-19 / A1 Wheelchairs - Part 19: Wheelchairs used as seats in motor vehicles - Amendment 1: Appendix G TS EN 61223-2-4A evaluation and routine testing in medical imaging departments-Section 2-4: Stability tests-Printing cameras

TS EN ISO 7488 Dental Amalgamators

TS EN ISO 16054 Surgical implants - Minimum data sets for surgical implants

TS EN ISO 7396-2 Medical gas piping systems - Part 2: Anesthetic gas release systems

TS EN ISO 15882 Sterilization of sanitary materials - Chemical indicators - Guidance for selection, use and evaluation of results (ISO 15882: 2008)

TS ISO 8061 / A1 Alpine ski bindings - selection of version torque values - Modified 1

TS EN ISO 10343 Ophthalmic instruments - Ophthalmometers (ISO 10343: 2014)

Non-invasive sphygmomanometers - Part 81060: Clinical investigation of the automatic measuring type (ISO 2-2: 81060)

tst EN 60627 Diagnostic x-ray imaging device - Characteristics of general-purpose and mammography-related anti-scatter gratings (IEC 60627: 2013)

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

TS EN ISO 10637 Dental equipment - High and medium volume suction systems

TS EN 15986 Symbols for the labeling of medical devices - Requirements for labeling of medical devices containing terephthalates

TS EN ISO 15883-4 Washer-disinfectors - Part 4: Specifications and tests for washer-disinfectors applying chemical disinfection for heat-resistant endoscopes

TS ISO 8061 Alpine ski bindings - selection of version torque values 12.06.2013 11.180.01

TS 9371 ISO 5832-2 / T1 (Number Modification: TS EN ISO 5832-2) Surgical Implants-Metallic materials-Part 2: Titanium without alloy

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

60601-1 / tst A12 Electrical medical equipment - Part 1: General rules for basic safety and required performance

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 60601-2-25 Medical electrical equipment - Part 2-25: Specific requirements for the essential safety and required performance of electrocardiographs (IEC 60601-2-25: 2011)

tst EN 60601-2-39 Electrical medical devices - Part 2-39: Particular requirements for the safety of peritoneal dialysis devices (IEC 60601-2-39: 2007)

TS EN 13975Vitro sampling methods for test acceptance of diognastic medical devices (statistical methods)

TS EN ISO 8536-1 Infusion equipment for medical use - Part 1: Glass infusion bottles

TS EN 14683 Surgical masks - Specifications and test methods

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 62366-1 / AC Medical devices - Part 1: Application of availability technique to medical devices

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

TS ISO 7206-10 Surgical implants - Partial and full hip joint prostheses - Part 10: Determination of static load resistance of modular femoral heads

TS EN ISO 6875 Dental equipment - Dental chair

TS EN ISO 10079-2 Medical aspiration equipment - Section 2: Hand-operated aspiration equipment (ISO 10079-2: 2014)

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)

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)

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)

TSE ISO / EN 13570-1 Wheelchairs - Part 1: Guidelines for the implementation of the ISO 7176 standard series on wheelchairs

Electrical medical devices - Part 60601-2: Particular features for the safety of peritoneal dialysis devices TS EN 39-11-2 / tst A39

TS EN ISO 18369-4 Optics - Eye-related - Contact lenses - Part 4: Physicochemical properties of contact lens materials

TS ISO 7176-8 Wheelchairs - Part 8: Characteristics and test methods for static, impact and fatigue strength

tst EN 13727 + A2 Chemical disinfectants and antiseptics - quantitative suspension test - For the assessment of bacterial killing in the medical field - Test method and requirements (step 2, step 1)

TS EN 61206 Ultrasound-Continuous wave doppler sratems-Test methods

TS EN ISO 11608-2 Pen injectors - for medical use - Part 2: Needles - Specifications and test methods

TS EN 14180 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and test

tst EN ISO 11979-2 Optics - Eye implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2: 2014)

TS ISO 7206-1 Surgical implants - Partial and full hip joint prostheses - Part 1: Classification and indication of dimensions

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 81-41 Elevators - Safety regulations for construction and installation - Special elevators for the transport of persons and goods - Part 41: Vertical lifting platforms for the use of people with mobility impairments

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 ISO 19980 Ophthalmic Instruments - Corneal topography

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 10555-5 Intravenous catheters-Sterile, single-use-Part 5: Peripheral catheters with needle

TS EN ISO 11990-1 Lasers and laser-related equipment - laser resistance determination in tracheal tubes - Part 1: Tracheal tube shaft

TS EN 1789 + A2 Medical vehicles and equipment - Road ambulances

TS EN ISO 12417-1 Cardiovascular implants and extracorporeal systems - Vascular device-pharmaceutical combined products - Part 1: General features

Molecular in vitro diagnostic investigations - Features of preliminary examination procedures for venous whole blood - Part 16835: Extracellular DNA isolation from plasma in circulation

TS ISO 5832-4 Surgical implants - Metallic materials - Section 4: Cobalt-Chromium-Molybdenum casting alloy

Flow meters for connection to terminal units of medical gas pipeline systems TS EN ISO 15002

TS EN ISO 7405 / A1 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1: Positive control material (ISO 7405: 2008 / Amendment 1: 2013)

tst EN ISO 11979-9 Ophthalmic implants - Interocular lenses - Part 9: Multifocal interocular lenses (ISO 11979-9: 2006)

Elastomeric parts for devices for parenteral and pharmaceutical use - Part 8871: Identification and characteristics - Amended 2 (ISO 1-2: 1 / Amd 8871: 2)

TS EN ISO 15883-2 Washer-disinfectors - part 2: Features and tests for washer-disinfectors applying thermal disinfection for surgical instruments, anesthesia equipment, cuvettes, containers, collection containers, kitchenware, glassware

TS EN 81-40 Elevators - Safety regulations for construction and installation - Special applications for passenger and freight elevators - Part 40: Stair elevators and inclined lifts for passengers with mobility impairments

TS EN ISO 15189 Medical laboratories - Requirements for quality and competence

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)

60601-2-21 Electrical medical equipment - Part 2-21: Specific requirements for the basic safety and performance of radiant baby heaters

TS ISO 5833 Surgical implants - Acrylic resin bone cements

TS ISO 7176-11 Wheelchairs - Part 11: Test dummies

TS EN 13726-3 Inactive medical devices - Test methods for primary dressings - Part 3: Waterproof

tst ISO 7206-8 Surgical implants - Partial and full hip joint prostheses - Part 8: Durability performance of rotating applied femoral components

ISO EN ISO 10993-12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12: 2012) 01.08.2014

80601-2 Electrical medical equipment - Part 69-2: Particular requirements for basic safety and performance of the oxygen concentrator (ISO 69-80601-2: 69)

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) 8

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)

TS ISO 5832-12 Surgical implants- Metallic materials- Part 12: Formable cobalt- Chromium- Molybdenum alloy

tst EN 62464-2 Magnetic resonance equipment for medical imaging - Part 2: Classification criteria for pulse sequences (IEC 62464 2: 2010)

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)

XBX-80601: Particular requirements for the basic performance and basic safety of anesthesia workstations (ISO 2-13-2: 13)

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 15854 Dentistry - Casting and base plate waxes

TS EN ISO 18369-3 Optics - Eye-related - Contact lenses - Part 3: Measurement methods

tst EN 61267 Medical diagnostic x-ray equipment - Radiation requirements for use in determining specifications (IEC 61267: 2005)

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 60601-2-24Electrical medical devices - Part 2-24: Specific requirements for the essential safety and required performance of infusion pumps and control units (IEC 60601-2-24: 2012)

TS EN ISO 17304 Dentistry - Polymerization shrinkage: Method for determining polymerization shrinkage of polymer based reinforcing materials

TS ISO 7176-22 Wheelchairs - Part 22: Installation procedures

60601-2-20 Electrical medical equipment - Part 2-20: Specific requirements for the basic safety and performance of infant transport incubators

TS ISO 7176-19 Wheelchairs - Part 19: Wheelchairs used as seats in motor vehicles

TS EN 14476 + A1 Chemical disinfectants and antiseptics - Virus killing quantitative suspension test for chemical disinfectants and antiseptics used in medicine - Test method and requirements (phase 2, step 1)

TS EN ISO 11334-1 Walking aids for use with an arm - Specification and test methods - Part 1: Elbow crutch

TS EN ISO 11607-1 Packaging for finally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

TS EN ISO 8598-1 Optics and optical instruments - Fucometers - Part 1: General-purpose instruments for measuring spectacle lenses

TS EN 61331-1 X-ray protective devices for diagnostic purposes in medicine Section 1: Determination of the attenuation properties of materials

TS EN 62353 Electrical medical equipment - Retest and test after repair of electrical medical equipment

tst EN 1865-1 + A1 Patient transport equipment for road ambulances - Part 1: General stretcher systems and patient transport equipment

TS EN ISO 7786 Dental rotating instruments - Abrasive laboratory instruments

TS EN ISO 80369-20 Small binders for liquids and gases in health care applications - Part 20: Common test methods

tst EN 61847 Ultrasound-Surgical systems-Measurement and notification of basic output characteristics

TS EN ISO 8871-2 Elastomeric parts for devices for parenteral and pharmaceutical use - Part 2: description and characteristics

TS EN ISO 9187-1 Injection equipment for medical use - Part 1: Ampoules for injectable medicines

TS EN 1040 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (stage 1)

TS EN 1640 Dentistry - Medical equipment for dentistry - Equipment

TS EN ISO 5364 Anesthesia and breathing apparatus - Oropharyngeal tubes

Electrical medical equipment - Part 60601-2: Specific requirements for basic safety and required performance of microwave treatment equipment TS EN 6-1-2 / A6

60601-2-21 / A11 Electrical and medical equipment - part 2-21: Particular requirements for basic safety and performance of radiant baby heaters

Dentistry - Periodontal curettes, tooth caverns and excavators - Part 13397: Periodontal curettes - Gr-Tip

TS EN 556-1 / AC Sterilization of medical devices - Specification for medical devices to be marked "sterile" - Part 1: Specifications for sterile medical devices

TS EN 556-1 / AC Sterilization of medical devices - Specification for medical devices to be marked as “sterile - - Part 1: Specifications of finally sterilized medical devices

TS EN ISO 8536-4 Infusion equipment for medical use - Part 4: Disposable infusion sets operated by gravity (ISO 8536-4: 2010)

TS EN 12312-16 + A1 Aircraft ground support equipment - Special requirements - Part 16: Air start equipment

TS EN ISO 21535 Non-active surgical implants - Joint replacement - Specific features for hip replacement

TS EN 13726-6 Inactive medical devices - Test methods for primary dressings - Part 6: Odor control

TS EN ISO 14971 Medical devices - Applying risk management to medical devices (ISO 14971: 2007; Revised edition 2007-10-01)

TS EN ISO 10993-2 Biological evaluation of medical devices - Part 2: Requirements for animal welfare (ISO 10993-2: 2006)

Electrical medical equipment - Part 60601-1: General rules for basic safety and required performance - Supplementary standard: General specifications, tests and guidance for warning systems in electrical medical equipment and electrical medical systems 8 1-8-11.040.01-XNUMX

tst EN 62570 Standard practice for safety marking of medical devices and other goods in a magnetic resonance environment (IEC 62570: 2014)

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)

Electrical equipment - Part 60601-2: Particular requirements for basic safety and performance of heart defibrillators (IEC 4-2-4: 60601)

TS EN ISO 15883-7 Washer-disinfectors - Part 7: Specifications and tests for non-invasive, non-critical heat-resistant medical devices and sanitary disinfecting washers for chemical disinfection

TS EN 12347 Biotechnology - Performance criterion for high steam spray sterilizing instruments and steam sterilizers

TS ISO 13405-1 Prostheses and orthoses - Classification and description of prosthetic components - Part 1: Classification of prosthetic components

TS 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

60601-1-8 / A1 / AC 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 6874 Dentistry - Polymer based pit and fissure sealants

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)

Electrical medical equipment - Part 60601: General rules for basic safety and required performance (IEC 1-1: 1 / A60601: 1)

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

60601-2-37 / tst A11 Electrical medical devices - Part 2-37: Specific features for the safety of ultrasonic medical diagnostic and imaging equipment

EN ISO 81060-1 Non-Invasive Sphygmomanometer Section 1: General Specifications (ISO 81060-1: 2007)

Optics - Eye - Contact lenses - Part 18369: Recommendations for terms, classification system and labeling specifications TS EN ISO 1-1 / A1

TS EN ISO 14729 / A1 Optics - Eye care - Contact lens care products - Microbiological rules and test methods for hygienic handling systems and products -Recovery 1 (ISO14729: 2001 / AM

TS EN ISO 22442-2 Medical devices using animal tissues and their derivatives - Part 2: Sourcing, collection and processing controls

TS EN 15224 Quality management systems - EN ISO 9001 for health care: 2015

TS EN ISO 29022 Dentistry - Adhesion - Gear-edge shear bond strength test

TS 6781 EN ISO 4135 Anesthesia and breathing equipment - Terms and recipes

TS EN 12347 Biotechnology - Performance criteria for steam sterilizers and autoclaves

TS EN 15927 Businesses - Served by hearing aid specialists

TSE CEN ISO / TR 22411: 2011Iso / ic guide to products and services that meet the needs of elderly and disabled people Ergonomics data and guidelines for the implementation of 71

TS EN 868-9 Packaging materials and systems for medical devices to be sterilized - Part 9: Uncoated non-woven polyolefin materials for the production of heat-sealable bags, rolls and closures - Specifications and test methods

TS ISO 5833 Surgical implants - Acrylic resin bone cements

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 11140-1 Sterilization of healthcare equipment - Chemical indicators - Part 1: General properties

TS EN ISO 13116 Dentistry - Test method for determining the radio-opacity of materials

TS EN 13060 Small steam sterilizers

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 16372 Cosmetic surgery services

TS EN 61910-1 Electrical medical equipment - Radiation dose documentation - Part 1: Formatted radiation dose report for radiography and radioscopy

TS EN ISO 10993-1 Biological assessment of medical devices - Part 1: Assessment and testing in a risk management process (ISO 10993-1: 2009)

TS EN ISO 7711-2 Dentistry- Rotating diamond tools - Part 2: Discs

TS EN ISO 10993-12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

TS EN ISO 14971 Medical devices - Risk management application to medical devices

TS EN ISO 10993-12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12: 2012)

TS EN ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of blood interaction experiments (including ISO 10993-4: 2002, A1: 2006)

TS EN ISO 10993-2 Biological evaluation of medical devices - Part 2: Requirements for animal welfare (ISO 10993-2: 2006)

TS EN ISO 15189 Medical laboratories - Requirements for quality and competence

TS EN ISO 1942 Dentistry - Terms

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

X NUMX-80601-2 Electrical and medical equipment - Part 12-2: Specific features for the safety of lung fans - Intensive care fans

TSE ISO / TS 11139 Sterilization of sanitary materials - Terms and definitions

TS EN 13731 Lift cushion systems for fire and rescue services - Safety and performance features

TS EN ISO 5356-1 Anesthesia and breathing equipment - Tapered fasteners - Section 1: Cones and sockets

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 ISO 23600 Auxiliary products for the visually impaired and visually impaired - Audible and audible signals for pedestrian traffic lights

TS ISO 23599 / T1 Auxiliary products for the visually impaired or visually impaired

TS EN ISO 11979-1 Eye implants - Intraocular lenses - Part 1: Terms and descriptions (ISO 11979-1: 2012)

TS EN 1499 Chemical disinfectants and antiseptics - Hygienic hand washing agent - Test methods and properties (stage 2 / step 2)

TS EN 1500 Chemical disinfectants and antiseptics - Hygienic hand scrubbing agent - Test methods and properties (stage 2 / step 2)

TS EN 12184 Electrically driven wheelchairs - Scooters and chargers - Characteristics and test methods

TS ISO 10936-2 Optical and optical devices - Surgical microscopes - part 2: Dangerous radiation caused by surgical microscopes used in eye surgery

TS ISO 7176-11 Wheelchairs - Part 11: Test dummies

TS ISO 7176-5 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering area

TS ISO 7176-2 Wheelchairs - Part 2: Determination of the dynamic balance of electric wheelchairs

TS ISO 7176-3 Wheelchairs - Part 3: Determination of the effectiveness of the brakes

TS ISO 7176-4 Wheelchairs - Part 4: Energy consumption of electrically operated wheelchairs and tricycles in the determination of theoretical distance range

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 )

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

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 standard for general diagnostic purposes for the protection of radiation in the x-ray device (IEC 3-1-1: 1.3)

TS EN ISO 7439 Intrauterine contraceptives - Copper - Features and tests

TS EN ISO 24234 Dentistry - Dental amalgam

TS EN ISO 5840-1 Cardiovascular implants - Heart valve prostheses - Part 1: General features

TS EN ISO 11117 Gas cylinders - Valve protection caps and valve casings - Design, construction and testing

Chemical disinfectants and antiseptics - Preservation of microbial strains used for the determination of bactericide and fungicidal activity

tst EN ISO 225 Fasteners - Screws, deflections and nuts - Short designations and symbols

TSE ISO / TS 11139 Sterilization of health care products - Terms and definitions

TS EN ISO 8637 Cardiovascular implants and extracorporeal systems - Hemodializers, hemodiafiltrers, hemofiltrers, hemoconcentrators (ISO 8637: 2010 and Modified 1: 2013-04-01)

TS EN ISO 21531 Dentistry - Graphic symbols for dental instruments (ISO 21531: 2009)

TS ISO 7176-19 Wheelchairs - Part 19: Wheelchairs used as seats in motor vehicles

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 ISO 10542-1 Technical systems and ancillary equipment for disabled or disabled persons - Wheelchair anchor and seat belt systems - Part 1: Specification and test methods for all systems

TS ISO 10542-1 / Cor 1 Technical systems and ancillary equipment for persons with disabilities or disabilities - Wheelchair restraint and seat belt systems - Part 1: Features and test methods for all systems

TS ISO 7176-8 Wheelchairs - Part 8: Characteristics and test methods for static, impact and fatigue strength

TS 9371 ISO 5832-2 / T1 (Number Modification: TS EN ISO 5832-2) Surgical Implants-Metallic materials-Part 2: Titanium without alloy

TS EN 62127-1 / A1 Ultrasonic-Hydrophones-Section 1: Identification and measurement of medical ultrasonic fields up to 40 MHz

tst EN ISO 3630-2 Root canal instruments for dentistry - Part 2: Expanders (ISO 3630-2: 2013)

tst EN ISO 13666 Ophthalmic optics - Spectacle lenses - Terms (ISO 13666: 2012) 11.040.70

TS EN ISO 8637 Cardiovascular implants and extracorporeal systems - Hemodializers, hemodiafiltrers, hemofiltrers, hemoconcentrators

TS EN ISO 8638 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for hemodializers, hemodiafiltrers, hemofiltres

TS EN 14683 Surgical masks - Specifications and test methods

TS EN ISO 21536 / A1 Non-active surgical implants - Joint implants - Specific features for knee joint implants

ISO EN ISO 8536-4 / A1 Infusion equipment for medical use - Part 4: Disposable infusion sets with gravity effect (ISO 8536-4: 2010 / Amended 1: 2013)

TS EN 1789 + A2 Medical vehicles and equipment - Road ambulances

tst EN ISO 20795-1 Dentistry-Base based resins-Part 1: Prosthetic base resins (ISO 20795-1: 2013)

tst EN ISO 20795-2 Dentistry-Base-based resins-Part 2: Orthodontic base resins (ISO 20795-2: 2013)

Electrical medical equipment - Part 60601-2: Particular requirements for the basic safety and required performance of X-ray equipment for computed tomography (IEC 44 / 1: 2)

TS EN ISO 7494-2 Dentistry - Units used in dentistry - Part 2: Air, water, suction and waste water systems

TS EN ISO 11137-2 Sterilization of sanitary materials - Radiation - Part 2: Determination of sterilization dose

TS EN 455-2 Disposable medical gloves - Part 2: Rules and tests for physical properties

TS EN 455-3 Medical gloves - Disposable - Part 3: Characteristics and tests for biological evaluation

TS EN ISO 15197 Extracorporeal medical diagnostic measuring systems - Characteristics of blood glucose monitoring systems used for personal measurement for the control of diabetes (diabetes mellitus)

TS EN ISO 8536-8 Infusion equipment for medical use - Part 8: Disposable infusion equipment for use with a pressure infusion device23.10.2015

TS EN ISO 8536-9 Infusion equipment for medical use - Part 9: Disposable fluid pathways for use with pressure infusion equipment23.10.2015

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 ISO 23640 Extracorporeal medical diagnostic equipment - Evaluation of stability of extracorporeal diagnostic reagents 23.10.2015 11.100.10

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

Molecular in vitro diagnostic investigations - Features of preliminary examination procedures for venous whole blood - Part 16835: Isolated cellular RNA

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

TSE CEN / TS 16826-1 Molecular in vitro diagnostic investigations - Properties of preliminary examination procedures for snap frozen tissue - Part 1: Isolated RNA

TSE CEN / TS 16826-2 Molecular in vitro diagnostic investigations - Characteristics of preliminary examination procedures for snap frozen tissue - Part 2: Isolated proteins

TSE CEN / TS 16827-1 Molecular in vitro diagnostic investigations - Characteristics of preliminary examination procedures for FFPE tissue - Part 1: isolated RNA

TSE CEN / TS 16827-2 Molecular in vitro diagnostic investigations - Characteristics of pre-examination procedures for FFPE tissue - Part 2: Isolated proteins

Molecular in vitro diagnostic investigations - Characteristics of pre-examination procedures for FFPE tissue - Part 16827: Isolated DNA TSE CEN / TS 3-3

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 / A1 Electrical medical equipment - Part 1-10: General requirements for basic safety and required performance-Auxiliary standard: Specification 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 features for basic safety and required performance of microwave therapy 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 ISO 11137-1 Sterilization of sanitary materials - Radiation - Part 1: Requirements for the development, validation and routine control of the sterilization process for medical devices (including ISO 11137-1: 2006, Amd 1: 2013)

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

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 / AC Electrical medical equipment - Part 2-33: Specific requirements for the 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

60601-2-41-1 / A2 Electrical medical equipment - Part 41-23.10.2015: Specific requirements for the basic safety and required performance of lighting fixtures used in surgical procedures and diagnosticsXNUMX

TS EN 60601-2-47 Electrical medical equipment - Part 2-47: Particular requirements concerning the essential safety and required performance of portable electrocardiograph systems

XENUMX-62220-1Electrical medical equipment - Characteristics of digital x-ray imaging devices - Part 1-1: Determination of sensor quantum yield - Detectors used in radiographic imaging

60601-2-37 / A1 Electrical medical devices - Part 2-37: Specific requirements for essential safety and required performance of ultrasonic medical diagnostic and imaging equipment

TS EN 60601-2-52 / A1 Electrical medical equipment - Part 2-52: Specific features for basic safety and necessary performance of patient beds

60601-2-54 / A1 Electrical medical equipment - Part 2-54: Specific 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 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 equipment23.10.2015

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 60601-2-11 Electrical medical equipment - Part 2-11: Particular requirements for basic safety and required performance of gamma ray therapy equipment

TS EN ISO 3826-1 Plastic foldable bags for human blood and blood components - part 1: Conventional blood bags

TS EN ISO 29022 Dentistry - Adhesion - Gear-edge shear bond strength test

TS EN ISO 7405 / A1 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Annex 1: Positive control material

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 ISO 16498 Dentistry - minimal dental implant data set for clinical use

TS EN 1865-2 + A1 Patient transport equipment for road ambulances - Part 2: Electric stretcher

TS EN 1865-3 + A1 Patient transport equipment for road ambulances - Part 3: Heavy duty stretcher

TS EN 16442 Controlled enclosure for thermolabile endoscopes

60601-2-8-1 / A2 Electrical medical equipment - Part 8-10: Specific requirements for essential safety and required performance of therapeutic x-ray equipment operating in the 1 kV to XNUMX MV range

TS ISO 7176-1 Wheelchairs - Part 1: Static balance determination

TS ISO 7176-6 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration in electric wheelchairs

TS ISO 7176-9 Wheelchairs - Part 9: Climate tests for electric wheelchairs

TS ISO 7176-14 Wheelchairs - Part 14: Power and control systems of electric wheelchairs and tricycles - Features and test methods

TS ISO 7176-10 Wheelchairs - Part 10: Determination of obstacles in electrically operated wheelchairs

TS ISO 5832-11 Surgical implants - Metallic materials section 11: Formable titanium 6-Aluminum 7-Niobium alloy

TS ISO 7176-16 Wheelchairs - Part 16: Ignition resistance of postural support equipment

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

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 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 60601-2-26Electrical medical devices - Part 2-26: Particular requirements for the essential safety and required performance of electroencephalography devices (IEC 60601-2-26: 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 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)

TS EN 556-2 Sterilization of medical devices - Specification for medical devices to be marked “STERILE - - Part 2: Characteristics of aseptically processed medical 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 15883-7 Washer-disinfectors - Part 7: Specifications and tests for non-invasive, non-critical heat-resistant medical devices and sanitary disinfecting washers for chemical disinfection

TS EN ISO 17937 Dentistry - Osteotome

TS EN ISO 13017 / A1 Dentistry - Magnetic attachments - Modified 1

TS EN ISO 18397 Dentistry - Power-driven dental scraper

TS EN ISO 10650 Dentistry - Power-activated polymerization activators

TS EN ISO 13397-5 Dentistry - Peridontal curettes, calculus scrapers and excavators - Part 5: Jacquette calculus scrapers