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  • +90 532 281 01 42
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Health Technology Anesthesia, Respiratory and Reanimation Equipment Standards

Our company provides internationally approved and accredited testing, inspection and inspection services to the following standards.

 

TS EN 13014 Gas samples for anesthetics and breathing apparatus tube connections 

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

TS EN 13014 / AC Gas samples for anesthesia and breathing apparatus tube connections 

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

Medical Gas Piping Systems - Part 2: Anesthetic Gas Evacuation 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

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

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

 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 18778 Breathing equipment - Newborn monitors - Specific features

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 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 

Tracheostomy tubes - Part 1282: Pediatric tubes (ISO 2-1: 2, modified)

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

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 

60601-2-21 Electrical medical devices - Part 2: Special rules for the safety of baby radiant heaters

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

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

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

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

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

Pressure regulators for use with medical gases - Section 10524: Pressure regulators with cylinder valves integrated in 3-1 / A3 

TS EN ISO 20072 Design verification of the Aeresol drug delivery device -Features and test methods

 7396-1 / A3 Medical gas piping systems - Part 1: Compressed medical gases and vacuum piping systems - Terms related to alarm systems

60601-2-20 / A11 Electrical and medical equipment - Part 2-20: Specific requirements for the basic safety and performance of the baby transport incubators 

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

TSE K 292 Medical oxygen gas 

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 18082 Anesthesia and breathing equipment - NIST low pressure connectors for medical gases 

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

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

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 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 18082 Anesthesia and breathing equipment - Interchangeable thread (NIST) low pressure connectors for medical gases 

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

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

 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 

Pressure regulators used in conjunction with medical gases - Section 10524: Pressure regulators integrated with cylinder valves - Modification 3: Filtration and information to be provided by the manufacturer 1 3

Pressure regulators used in conjunction with medical gases - Part 10524: Low pressure regulators 4 

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

TS ISO 11040-3 Pre-filled syringes - Section 3: Caps for local anesthesia cartridges of dentistry 

TS EN ISO 23747 Anesthetics and respiration related equipment - Peak exhalation flow meter for the assessment of lung function in spontaneous breathing 

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: 2012)

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

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

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 

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 10079-1 Medical aspiration equipment - Section 1: Electrically operated aspiration equipment 

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

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 Feed units for medical environments 27.05.2016 11.040.10

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 EN ISO 5361 Anesthesia and breathing equipment - Trachea tubes and fittings 

TS EN ISO 5364 Anesthesia and breathing equipment - Oropharyngeal tubes 09.12.2016 11.040.10

TS EN ISO 5366 Anesthesia and breathing equipment - Tracheostomy tubes and fittings 09.12.2016 

60601-2-19 / A1 Electrical and medical equipment - Part 2-19: Specific requirements for basic safety and performance of infant incubators 

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

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

tst 2017114886 Medical oxygen gas 

TS ISO 27427 Anesthesia and breathing equipment - Nebulizing systems and components

EN ISO 5359 Anesthesia and breathing 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 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 EN ISO 407 Small gas cylinders-Portable-For the gases used in medicine, pin-coded yoke-type valve connections

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

Tracheostomy tubes - Part 1282: Pediatric tubes

Tst EN 1733 (Priority 6) Suction catheters - Used in the respiratory tract

TS EN 1820 + A1 Anesthetic reservoir balloon (iso 5362: 2000, modified) 

TS 3402 Marking for gas in gas cylinders used in medicine

TS 3402 / T1 Marking for gas in gas cylinders used in medicine

TS EN ISO 26782 / AC Anesthesia and breathing equipment - Spirometers designed to measure time-dependent exhalation volumes in humans

TS 6599 Tracheostomy cannula-Metal

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

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 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

Pressure regulators for medical gases - section 10524: Pressure regulators and pressure regulators with flowmeters 

Pressure regulators for medical gases - Section 10524: Low pressure regulators designed for insertion into medical equipment

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 EN 13014 Connection of gas sampling tubes to anesthesia and breathing equipment 

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 

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 

Respiratory treatment devices - Part 13544: Nebulizer systems and components  

Respiratory therapy devices - Part 13544: Piping system and fittings 

Respiratory therapy devices - Part 13544: Air distribution devices

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 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

Sleep apnea respiratory therapy - part 17510: Sleep apnea respiratory therapy equipment

Medical devices for the protection of oxygen and oxygen mixtures

TS EN ISO 21969 High pressure flexible fasteners for use with medical gas systems

TS EN ISO 26782 Anesthesia and breathing equipment - Spirometers designed to measure time-dependent exhalation volumes in humans

TS EN 60601-2-20 / A11 Electrical medical equipment - Part 2-20: Specific features for the 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

Transient breathing stop in sleep Breathing therapy in sleep-part 17510: Temporary breathing in sleep Breathing device in breathing