Medical Equipment Standards

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

TS EN 27740 Surgical instruments, removable head scalpels - Connection sizes

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

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

TS EN 61168 Radiotherapy simulators, functional performance characteristics

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

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

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

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

TS EN 60601-3-1 Medical electrical equipment - Part 3-4: Basic performance rule for oxygen and carbon dioxide partial pressure monitoring equipment passing through the skin

TS EN ISO 11985 Ophthalmic optics - Contact lenses - Aging of contact lenses with UV and visible radiation (in vitro method)

TS EN 60601-2-40 Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and call answering equipment

TS EN ISO 7886-2 Disposable hypodermic syringe - Part 2: Syringes for use with force-driven syringe pump

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

TS EN 60522 Determination of permanent filtration of X-ray tube system

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

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

Surgical implants - Metallic materials - Part 5832: Non-alloy titanium TS EN ISO 2-9371 (Former number: TS 5832 ISO 2-2)

TS EN 60526 Cables - Plug and socket connections for high-voltage cable for medical x-ray machine

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

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

TS EN 60522 Determination of permanent filtration of X-ray tube systems

TS EN ISO 14729 Optical and optical instruments - Contact lenses and contact lens care products - Antimicrobial activity of products for disinfection of contact lenses

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

TS EN 61828 Ultrasonic - Focusing transducers - Definitions and measurement methods for transmitted areas

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

TS EN 45502-2-1 Active implantable medical devices - Part 2-1: Specific features for active implantable medical devices designed for the treatment of bradyarrhythmia (pacemakers)

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

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

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

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

tst EN ISO 5840 Cardiovascular implants - Heart valve prostheses

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

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

Pressure regulators for use with medical gases - Section 10524: Manifold and line pressure regulators

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

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

TS EN ISO 19054 Supporting rail systems for medical equipment

TS EN ISO 19106 Geographical information-Profiles

TS EN ISO 11979-5 Ophthalmic implants - Interocular lenses - Part 5: Biocompatibility

TS EN ISO 11979-10 Optics - Eye implants - Intraocular lenses - Part 10: Phakic intraocular lenses

TS EN 14931 Pressure vessels for human use (pvho) - Pressure chamber systems with multiple seats for hyperbaric treatment - Performance, safety requirements and tests

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

TS EN ISO 8871-4 Elastomeric parts for devices for parenteral and pharmaceutical use - Part 4: Biological properties and test methods

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

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

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

TS EN ISO 8980-2 / ACOptic - Eye-related - Uncut, ready-to-use eyeglass lenses - Part 2: Technical specifications of improved power lenses

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

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

TS EN 62464-1 Magnetic resonance equipment for medical imaging - Part 1: Determination of the required image quality parameters.

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

TS EN ISO 9170-1 Terminals for medical gas pipeline systems - Part 1: Terminals for compressed medical gases and vacuum

End units for medical gas pipeline systems - Part 9170: End units for anesthetic gas cleaning systems

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

TS EN ISO 8536-3 Infusion equipment for medical use - Part 3: Aluminum caps for infusion bottles

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

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

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

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

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

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

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

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

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

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

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

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

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

TS EN ISO 11981 Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lenses and contact lens care products

TS EN ISO 8536-3 Infusion equipment for medical use - Part 3: Aluminum caps for infusion bottles

TS EN ISO 18777 Breathing equipment - Newborn monitors - Specific features

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

TS EN 60601-2-31 Electrical medical equipment - Part 2-31: Specific features for the safety of external pacemakers with an internal power supply

TS EN ISO 18777 Portable liquid oxygen systems for medical use - Specific features

TS EN 60601-2-54 Electrical medical equipment - Part 2-54: Particular requirements for the basic safety and required performance of x-ray equipment used in radiography and radioscopy

TS 3521-1 EN 20594-1 / AC Tapered fittings,% 6 (luer) taper - For syringes, needles and other medical supplies used in medicine - Part 1: General specifications

TS EN ISO 9360-2 Anesthetics and breathing equipment - Temperature and humidity changers (IDs) - Humidification of inhaled gases for humans - Part 2: Inds for use in patients undergoing tracheostomy with a minimum TNC volume of 250

Lung ventilators for medical use - Particular requirements for basic safety and performance - Part 10651: Respiratory support devices for home care

Sleep apnea breathing therapy - Part 17510: Sleep apnea respiratory therapy equipment

Sleep apnea breathing therapy - Part 17510: Masks and application accessories TS EN ISO 2-2

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

TS EN 301489-29 V1.1.1 Electromagnetic compatibility and radiospectrum issues (erm) Electromagnetic compatibility (emu) standard for radio equipment; Part 29: Special requirements for medical data service devices (meds) operating in the 401 mhz to 402 mhz and 405 mhz to 406 mhz bands

TS EN 80601-2-59 Medical electrical equipment - Part 2-59: Characteristics related to the basic safety and performance of the screen thermal graphics for monitoring human fever (IEC 80601-2-59: 2008 + corrected 2009)

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

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

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

TS ISO 7206-6 Surgical implants - Partial and full hip joint prostheses - Part 6: Test of the strength characteristics of the neck region of the stalked femoral components and performance rules

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

TS ISO 7206-4 Surgical implants - Partial and full hip joint prostheses - Part 4: Determination of strength characteristics and performance of stem femoral components

TS ISO 7206-2 Surgical implants - Partial and full hip joint prostheses - Part 2: Movable surfaces made of metal, ceramic and plastic materials

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

TS EN 60601-1-6 Medical electrical equipment - Part 1-6: General rules for basic safety and required performance - Subsidiary standard: Ease of use

TS EN 60613 Electrical, thermal and loading characteristics of rotary anode x-ray tubes for medical diagnosis

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

TS EN ISO 9360-1 Anesthetic and breathing equipment - Temperature and humidity changers (IDs) - For humidification of breathing gases by humans - Section 1: Intds for use with minimum Tidal volumes of 250 ml

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

X NUMX-60601-2 Electrical medical equipment - Part 19-2: Specific requirements for the basic safety and performance of baby incubators

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

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

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

TS EN ISO 7886-3 Syringes - Sterile hypodermic - Disposable Section 3: Self-unavailable syringes for fixed dose immunization

TS EN ISO 7886-4 Syringes - Sterile hypodermic - Disposable - Part 4: Disposable syringes

TS EN 60601-2-2 Electrical medical equipment - Part 2 - 2: Specific requirements for essential safety and required performance of high-frequency surgical equipment and high-frequency surgical accessories

TS EN 60601-2-44 Electrical medical equipment - Part 2-44: Specific requirements for the essential safety and required performance of X-ray equipment for computed tomography (IEC 60601-2-44: 2009)

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

TS EN ISO 9187-1 Injection equipment for medical use - Part 1: Ampoules for injectable medicines (ISO 9187-1: 2010)

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

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

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

TS EN 1060-3 + A2 Non-invasive sphygmomanometers - Part 3: Complementary features for electromechanical blood pressure measurement systems

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

Respiratory therapy devices - Part 13544: Piping system and fittings

Respiratory therapy devices - Part 13544: Air distribution devices

TS EN 60601-2-2 Electrical medical devices - Part 2-2: Specific features for the safety of diagnostic and therapeutic laser devices

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

TS EN ISO 7886-4 Syringes-Sterile-Hypodermic-Disposable-Part 4: Syringes with anti-reuse properties

TS EN ISO 10342 Optics - Eye Devices - Eye refractometers

TS EN 61223-3-2 Routine testing and evaluation in medical imaging departments - Part 3 - 2: Acceptance tests - Imaging performance of mammography x-ray device

TS EN 60601-2-33 Electrical medical equipment - Part 2-33: Specific features for the safety of extracorporeal medical diagnostic magnetic resonance equipment

TS EN ISO 14729 / A1Optics - Eye care - Contact lens care products - Microbiological rules and test methods for hygienic handling systems and products -Edit 1 (ISO14729: 2001 / AM 1: 2010)

TS EN 45502-2-2 / AC Active implantable medical devices - Part 2-2: Specific features for implantable active medical devices designed to treat bradyarrhythmia (implantable defibrillators)

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

TS EN 60601-1-8 / AC: 2010 Electrical medical equipment - Part 1-8: General rules for basic safety and required performance - Supplementary standard: General specifications, tests and guidance for electrical medical equipment and warning systems in electrical medical systems

TS EN ISO 11986 Optics - Eye - Contact lenses and contact lens care products - Determination of uptake and release of preservatives

Breathing system filters for inhalation and anesthesia use - Section 23328: Salt test method to assess filtration performance

Small probe fittings for liquids and gases in healthcare applications - Part 80369: General specifications

TS EN ISO 7886-3 Syringes-Sterile-Hypodermic-Disposable-Section 3: Automatic syringes that cannot be used automatically for fixed dose immunization

Electrical medical equipment - Part 60601-2: Particular requirements for the essential safety and required performance of external pacemakers with internal power supply (IEC 31-1-2: 31: 60601)

TS EN 62464-2 Magnetic resonance equipment for medical imagery - Part 2: Classification criteria for pulse sequences "

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

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

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

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

TS EN 80001-1: 2011 Application of risk management for IT networks for medical devices - Part 1: Roles, responsibilities and activities

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

TS EN 60601-2-50 / A11 Electrical medical equipment - Part 2-50: Specific requirements for essential safety and required performance of baby phototherapy equipment

TS EN 16082 Airport and aviation security services

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

TS EN 60601-2-46 Medical electrical equipment - Part 2 - 46: Specific features for basic safety and significant performance of operating tables

TS EN ISO 10943 Ophthalmic instruments - Indirect ophthalmoscopes

Electrical medical equipment - Part 60601-2: Particular requirements regarding the basic safety and required performance of luminaires used in surgical interventions and diagnostics: TS EN 41-11-2 / A41

TS EN ISO 8362-4 Injection containers and accessories - Part 4: Injection vials made of molded glass

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

TS EN ISO 15747 Plastic containers for intravenous injection

80601-2-35 / A11 Medical electrical equipment - Part 2-35: Particularly relevant for the necessary performance and basic safety of heating devices intended for heating in medical use using blankets, pillows and mattresses

TS EN ISO 14602 Inactive (fixed) surgical implants - Implants for osteosynthesis - Specific features

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

60601-2-2 / A11 Electrical medical equipment - Part 2-2: Specific requirements for basic safety and required performance of high-frequency surgical equipment and high-frequency surgical accessories

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

TS EN 61217 Radiotherapy equipment - Coordinates, motions and scales

TS EN 60731 Medical equipment - Ion chamber dosers for radiotherapy

TS EN ISO 8624 Optics - Eye - Eyeglass frames - Measuring system, terms and recipes

Optics - Eye - Contact lens care products - Microbiological rules and test methods for hygienic systems and products TS EN ISO 14729: 2001 / A1

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

TS EN ISO 24598 Welding consumables - Solid wire electrodes for submerged arc welding of creep resistant steels, tubular flux cored electrodes and electrode powder / combinations - Classification

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

TS EN ISO 25539-3 Cardiovascular implants-Endovascular devices-Part 3: Vena cava filters

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

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

TS EN ISO 19980 Ophthalmic Instruments - Corneal topography

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

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

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

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

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

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

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

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

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

TS EN ISO 14630 Inactive surgical implants - General features

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

TS EN ISO 25539-2 Heart and vascular implants-Section 2: Vascular stents

TS EN ISO 80601-2-13Electrical medical devices - Part 2-13: Particular requirements for basic performance and basic safety of anesthesia workstations

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

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

TS EN ISO 10685-3: 2012 Ophthalmic optics-Electronic catalog and identification of spectacle frames and sunglasses-Part 3: Technical information

TS EN ISO 10341 Ophthalmic instruments - Refractory heads

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

TS EN 60601-2-65 Electrical medical devices - Part 2-65: Particular requirements for basic safety and required performance of dental intra-oral X-ray equipment

TS EN ISO 8536-4 Infusion equipment for medical use section 4: Disposable infusion sets operated by gravity

TS EN ISO 8536-5 Infusion equipment for medical use - Section 5: Disposable burette-type infusion sets operating under gravity

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

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

TS EN ISO 5840-3 Cardiovascular implants - Cardiac valve prosthesis - Transcatheter replacement of heart valves

TS EN ISO 8536-4 / A1Infusion equipment for medical use part 4: Disposable infusion sets operated by gravity

TS EN ISO 19001 Extracorporeal medical diagnostic devices - Information provided by the manufacturer with extracorporeal medical diagnostic reagents for staining in biology

TS EN 61157 / A1 Ultrasonic devices - used in medical diagnosis - Acoustic output declaration rules

TS EN 61689 Ultrasonic-Physical Therapy Systems-Field characteristics and measurement methods in the frequency range 0,5 mhz to 5 mhz

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

TS EN 80601-2-30 Electrical medical equipment - Part 2-30: Specific features for safety, including the required performance of noninvasive automatic repeated blood pressure monitoring equipment

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

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

TS EN 61676 / A1 Electrical medical devices - Dosimetric instruments for non-invasive measurement of X-ray tube voltage in diagnostic radiology (IEC 61676: 2002 / A1: 2008)

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

TS EN ISO 10555-1 Intravenous catheters - Sterile disposable - Section 1: General specifications (ISO 10555-1: 2013, Adjusted edition 2013-07-01) 31.12.2014

TS EN ISO 10555-3 Intravenous catheters - Sterile, single-use - Part 3: Central venous catheters

60601-2-45-2 Electrical medical devices - Part 45-XNUMX: Specific requirements for the safety of mammographic x-ray equipment and mammographic stereotactic devices and their required performance

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

TS EN ISO 10555-1 Intravenous catheters - Sterile, single-use - part 1: General features

TS EN ISO 10555-3 Intravenous catheters-Sterile, single-use-Section 3: Central venous catheters

TS EN ISO 10555-4 Intravenous catheters-Sterile, single-use-Section 4: Balloon expansion catheters

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

TS EN 60601-1-3 / A1Electrical medical devices section 1: General rules for safety - Part 1.3 standard for general diagnostic purposes for the protection of radiation in the x-ray device for diagnostic purposes

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

60601-2-33 / A11 Electrical medical equipment - Part 2-33: Specific features for the safety of extracorporeal medical diagnostic magnetic resonance equipment

TS EN ISO 80601-2-12Electrical medical equipment - Part 2-12: Specific features for the safety of lung ventilators - Intensive care ventilators

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

Electrical medical equipment - Part 60601-2: Particular requirements regarding the basic safety and required performance of surgical luminaires used in surgical interventions and diagnostics TS EN 41-2009-11: 2 / A41

TS EN 1041 + A1 Information supplied by the manufacturer with medical devices

TS EN ISO 15798 Ophthalmic Implants - Ophthalmic Visco Surgical Instruments

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

TS EN ISO 14889 Optics - Eye - Eyeglass lenses - Basic rules for uncut, ready-to-use lenses

TS EN 1041 + A1 Information provided by medical device manufacturers

TS ISO 7206-10 Surgical implants - Partial and full hip joint prostheses - Part 10: Determination of the resistance of modular femoral caps to static loads

TS EN ISO 11499 Dentistry - disposable cartridges for local anesthetics

Non-invasive blood pressure monitor - Section 81060: Clinical investigation of the types of automated measurement

TS EN ISO 10079-2 Medical aspirators (suction equipment) - Part 2: Manually operated aspirators

Medical aspirators (suction equipment) - Part 10079: aspiration equipment supplied by vacuum or pressure source

TS EN ISO 8871-2 / A1 Elastomeric parts for devices for pharmaceutical and pharmaceutical use - Part 2: Description and characteristics-Amended 1

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

TS EN ISO 10343 Ophthalmic Instruments - Ophthalmometers

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

11979-2 Optics - Eye implants - Intraocular lenses - Part 2: Optical properties and test methods

Optics - Eye implants - Intraocular lenses - Part 11979: Multifocal intraocular lenses TS EN ISO 9-1 / A9

11979-2 Optics - Eye implants - Intraocular lenses - Part 2: Optical properties and test methods

Optics - Eye implants - Intraocular lenses - Part 11979: Multifocal intraocular lenses TS EN ISO 9-1 / A9

TS EN 60601-2-43 / ACElectrical medical devices - Part 2-43: Particular requirements for the safety of x-ray equipment for interfering methods

TS EN 60601-2-27 Medical electrical equipment - Part 2-27: Specific requirements for the required performance and safety of electrocardiographic monitoring equipment

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

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

TS EN ISO 13212 Ophthalmic optics - Contact lens care products - Guidance for determination of shelf life

TS EN ISO 5359 Anesthesia and breathing equipment - Low pressure hose fittings for use with medical gases

TS EN ISO 5367 Anesthesia and Respiratory Equipment - Breathing sets and fittings

Suction catheters used in respiratory tract TS EN ISO 8836

TS EN ISO 11978 Ophthalmic optics - Contact lenses and contact lens care products - Labeling

TS EN ISO 11979-6 Optics - Eye - Implants - Intraocular lenses - Part 6: Shelf life and transport stability test

TS EN ISO 12870 Ophthalmic optics - Spectacle frames - Rules and test methods

TS EN ISO 14730 Optics - Eye care - Contact lens care products - Antimicrobial protection efficacy test and expiry date determination guide

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

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

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

TS EN 61331-3 X-ray protective devices for medical diagnosis - Part 3: Protective clothing, goggles and protective patient armor

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

TS EN 13718-1 Medical instruments and equipment - Air ambulances - Part 1: Characteristics of medical devices used in air ambulances

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

TS EN ISO 11990-2 Lasers and laser-related equipment - laser resistance determination of tracheal tubes - Part 2: Tracheal tube cuffs

TS EN ISO 21536 / A1 Non-active surgical implants - Joint implants - Specific features for knee joint implants-Amended 1 (ISO 21536: 2007 / Amd 1: 2014)

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

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

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

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

Ophthalmic implants - Interocular lenses - Part 11979: Multifocal interocular lenses (ISO 9-1: 9 / Amd 11979: 9)

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

TS EN 61675-1 Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomography devices (IEC 61675-1: 2013)

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

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

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

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

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

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

S EN ISO 80601-2-69 Electrical medical equipment - Part 2-69: Specific requirements for basic safety and required performance of oxygen concentrator equipment (ISO 80601-2-69: 2014)

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

TS EN 60601-2-43 Electrical medical equipment - Part 2-43: Specific requirements for essential safety and required performance of the X-ray equipment for interventional procedures (IEC 60601-2-43: 2010)

TS EN 60601-2-43 / AC Medical electrical equipment - Part 2-43: Specific requirements for essential safety and required performance of X-ray equipment for interventional procedures

tst EN 60601-2-34 Electrical medical devices - Part 2-34: Particular requirements for the safety of interventional blood pressure monitoring equipment including the required performance (IEC 60601-2-34: 2011)

TS EN 60601-2-27 Medical electrical equipment - Part 2-27: Specific features for the essential safety and required performance of electrocardiography monitoring equipment (IEC 60601-2-27: 2011 + Correction May 2012)

tst EN 60601-1-9 Electrical medical equipment - Part 1-9: General specifications for basic safety and performance required - Supplementary standard: Specification for environmentally conscious design (IEC 60601-1-9: 2007)

Electrical medical equipment - Part 60601-1: General requirements for basic safety and performance - Auxiliary standard: Specifications for environmentally conscious design (IEC 9-1-1: 9 / A60601: 1 )

tst EN 60601-1-8 Electrical medical equipment - Part 1-8: General rules for basic safety and required performance - Supplementary standard: General specifications, tests and guidance for electrical medical equipment and warning systems in electrical medical systems (IEC 60601-1-) 8: 2006)

Electrical medical equipment - Part 60601-1: General rules for basic safety and required performance - Supplementary standard: General specifications, tests and guidance for electrical medical equipment and warning systems in electrical medical systems (IEC 8) -1-1: 8 / A60601: 1)

TS EN 60601-1-8 / A1 Electrical medical equipment - Part 1-8: General rules for basic safety and required performance - Subsidiary standard: General specifications, tests and guidance for warning systems in electrical medical equipment and electrical medical systems

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

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

tst EN 60601-1-3 Electrical medical devices section 1: General rules for safety - Part 1.3 standard for general diagnostic purposes for radiation protection in the x-ray device (IEC 60601-1-3: 2008)

Electrical medical devices section 60601: General rules for safety - Part 1 general standard for the protection of radiation in the standard diagnostic x-ray device for diagnostic purposes (IEC 3-1-1.3: 60601)

Electrical medical devices section 60601: General rules for safety - Part 1 standard for general diagnostic purposes for the protection of radiation in the x-ray device (IEC 3-1-1: 1.3)

60601-1-3 / A1 / tst AC Electrical medical devices section 1: General rules for safety - Part 1.3 standard for general diagnostic purposes for radiation protection in the x-ray device for diagnostic purposes

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

60601-2-44 / A1Electrical medical equipment - Part 2-44: Particular requirements for basic safety and required performance of X-ray equipment for computed tomography

TS EN ISO 11608-1 Pen syringes for medical use - Part 1: Pen syringes - Specifications and test methods

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

TS EN ISO 14534 Optical and optical instruments - Contact lenses and contact lens care products - Key features

TS EN ISO 11070 Intravenous catheters - Sterile - Disposable catheter servers

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

TSE CEN / CLC / TR 14060: 2014 Ensuring traceability of medical devices with unique device identification (UDI)

TS EN 60731 Medical equipment - Ion chamber dosers for radiotherapy

Pressure regulators used in conjunction with medical gases - Section 10524: Manifold and line pressure regulators

Pressure regulators used in combination with medical gases - Section 10524: Pressure regulators integrated in cylinder valves

TS EN ISO 10524-3 / A1 Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves - Amendment 1: Filtering and information to be provided by the manufacturer

TS EN ISO 10524-4 Pressure regulators for use with medical gases - Part 4: Low pressure regulators

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

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

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

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

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

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

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

TS ISO 8536-7 Infusion equipment for medical use - Part 7: Aluminum-plastic combination caps for infusion bottles

TS ISO 10985 Caps made of aluminum plastic combinations for infusion bottles and injection vials - Specifications and test methods

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

TS ISO 13405-2 Prostheses and orthoses - Classification and description of prosthetic components - Part 2: Identification of lower limb prosthetic components

TS ISO 13405-3 Prostheses and orthoses - Classification and description of prosthetic components - Part 3: Identification of upper limb prosthetic components

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

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

Cardiovascular implants - Heart valve prostheses - Part 5840: Surgically implanted heart valve substitutes TS EN ISO 2-2

TS EN ISO 16061 Instruments used with inactive surgical implants - General features

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

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

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

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

TS EN 45502-1 Surgical implants - Active implantable medical devices - Part 1: General rules on safety, marking and information to be provided by the manufacturer

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

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

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

TS EN ISO 16672 Ophthalmic implants - Ocular inner pads

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

Electrical medical equipment - Part 60601-1: General rules for basic safety and required performance - Auxiliary standard: Ease of use TS EN 6-1-1 / A6

TS EN 60601-1-10 / A1Electrical medical equipment-Section1-10: General specifications for basic safety and required performance-Auxiliary standard: Features for the development of physiological closed-loop controllers

TS EN 60601-1-11 Electrical medical equipment - Part 1-11: General rules for basic safety and required performance - Subsidiary standard: Specifications for medical electrical equipment and medical electrical systems used in the domestic health environment

TS EN 60601-2-3 Electrical medical equipment - Part 2-3: Specific features for basic safety and required performance of short-wave therapy equipment

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

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

TS EN 60601-2-24 Electrical medical devices - Part 2-24: Specific requirements for essential safety and required performance of infusion pumps and controllers

TS EN 60601-2-26 Electrical medical devices - Part 2-26: Specific requirements for the essential safety and required performance of electroencephalography devices

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

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

TS EN 60601-2-36 Electrical medical equipment - Part 2-36: Specific features for the basic safety and required performance of the equipment used for the external and external fractures of the kidney and gallbladder

60601-2-41 / A1Electrical medical equipment - Part 2-41: Specific requirements for the basic safety and required performance of lighting fixtures used in surgical interventions and diagnostics

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

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

TS EN 60601-2-37 / A1Electrical medical devices - Part 2-37: Specific requirements for the essential safety and required performance of ultrasonic medical diagnostic and imaging equipment

TS EN 60601-2-54 / A1Electrical medical equipment - Part 2-54: Particular requirements concerning the essential safety and required performance of x-ray equipment for radioscopy and radiography

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

TS EN 60601-2-63 Medical electrical equipment - Part 2-63: Specific requirements for the essential safety and necessary performance of the extra-oral x-ray equipment used in dentistry

TS EN 60601-2-64 Electrical medical equipment - Part 2-64: Specific features for the basic safety and required performance of light ion beam medical electrical equipment

TS EN 60601-2-68 Electrical medical equipment - Part 2-68: Specific features for the essential safety and required performance of X-ray based image guided radiotherapy equipment, light ion beam treatment equipment and radionuclide radiation treatment equipment used in conjunction with electron accelerators

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

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

TS EN 80601-2-58 Electrical medical equipment - Part 2-58: Specific features for basic safety and required performance of lens removal devices and vitrectomy devices for ophthalmic surgery

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

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

TS EN 60601-2-16 Electrical medical devices - Part 2-16: Specific requirements for basic safety and required performance of hemodialysis, hemodiafiltration and hemofiltration devices

TS EN 60601-1-12 Electrical medical equipment - Part 1-12: General rules for basic safety and required performance - Supplementary standard: Specification for medical electrical equipment and medical electrical systems used in the emergency medical service environment

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

TS EN 60601-2-17 Electrical medical equipment - Part 2-17: Specific features for the essential safety and required performance of automatic controlled brachytherapy equipment

TS EN 62366-1 Medical devices - Part 1: Application of availability technique to medical devices

TS EN 80601-2-30 / A1Electrical medical equipment - Part 2-30: Specific features for the essential safety and essential performance of noninvasive automatic repeated blood pressure monitoring equipment

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

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

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

TS EN ISO 18490 Non-Destructive Testing - Measurement of visual acuity of NDT personnel

TS EN ISO 11663 Quality of dialysis fluid for hemodialysis and related treatments

TS EN 60601-1 / A1 / ACElectrical medical equipment - Part 1: General rules for basic safety and required performance (IEC 60601-1: 2005 / A1: 2012 / Revision July 2014)

TS EN ISO 13958 Concentrated solutions for hemodialysis and hemodialysis-related treatments

TS EN ISO 13959 Properties of water used in hemodialysis and hemodialysis-related treatments

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

TS EN 60601-1 / A1 / ACElectrical medical equipment - Part 1: General rules for basic safety and required performance (IEC 60601-1: 2005 / A1: 2012 / Revision July 2014)

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

TS EN ISO 1135-5Transfusion equipment for medical use - Part 5: Disposable transfusion sets used with pressure infusion equipment

TS EN 60601-2-8 / A1Electrical medical equipment - Part 2-8: Particular requirements for the essential safety and required performance of therapeutic x-ray equipment operating in the 10 kV to 1 MV range

TS EN 60601-2-45 / A1Electrical medical equipment - Part 2-45: Particular requirements and safety requirements for the safety of mammographic x-ray equipment and mammographic stereotactic devices

TS EN 60601-2-33 / A2Electrical medical equipment - Part 2-33: Specific requirements for essential safety and required performance of extracorporeal medical diagnostic magnetic resonance equipment

Particular requirements for the basic safety and required performance of electron accelerators in the range 60601 MeV - 2 MeV: Part 1-2 Electrical medical equipment - Part 1-1

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

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

TS EN 60601-2-5 Electrical medical equipment - Part 2-5: Specific requirements for basic safety and required performance of ultrasonic physiotherapy equipment

TS EN 60601-2-23 Medical electrical equipment - Part 2-23: Key features for the basic safety and required performance of partial pressure monitoring devices through the skin

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

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

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

tst EN 61223-3-5 Evaluation and routine tests in the medical imaging department - Part 3-5: Acceptance tests- Image performance for X-ray computed tomography (IEC 61223-3-5: 2004)

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

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

tst EN 60601-2-65 Electrical medical devices section 2-65: Particular requirements for basic safety and necessary performance of dental intra-oral X-Ray equipment (IEC 60601-2-65: 2012)

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

tst EN 60601-2-45 Electrical medical devices - Part 2-45: Particular requirements and performance for the safety of mammographic x-ray equipment and mammographic stereotactic devices (IEC 60601-2-45: 2011)

Electrical medical equipment - Part 60601-2: Particular requirements for the safety of mammographic x-ray equipment and mammographic stereotactic devices (IEC 45-1-2: 45)

tst EN 60601-2-33 Electrical medical equipment - Part 2-33: Specific requirements for the safety of extracorporeal medical diagnostic magnetic resonance equipment (IEC 60601-2-33: 2010)

Electrical medical equipment - Part 60601-2: Particular requirements for basic safety and required performance of medical diagnostic magnetic resonance equipment (IEC 33-1-2: 33 / 60601)

Electrical medical equipment - Part 60601-2: Specific features for the safety of extracorporeal medical diagnostic magnetic resonance equipment TS EN 33-11-2 / tst A33

Electrical medical equipment - Part 60601-2: Particular requirements for the essential safety and required performance of external medical diagnostic magnetic resonance equipment (IEC 33-2: 2: 33)

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

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

tst EN 62464-1 Magnetic resonance equipment for medical imaging - Part 1: Determination of the required image quality parameters (IEC 62464-1: 2007)

tst EN 60601-2-37 Electrical medical devices - Part 2-37: Specific requirements for the safety of ultrasonic medical diagnostic and imaging equipment (IEC 60601-2-37: 2007)

Electrical medical devices - Part 60601-2: Particular requirements for the essential safety and required performance of ultrasonic medical diagnostic and imaging equipment (IEC 37-1: 2: 37)

tst EN 60601-2-26 Electrical medical devices - Part 2-26: Specific properties for basic safety and required performance of electroencephalography devices (IEC 60601-2-26: 2012)

tst EN 60601-2-26 Electrical medical devices - Part 2-26: Specific requirements for the essential safety and required performance of electroencephalography devices (IEC 60601-2-26: 2012)

tst EN 60601-2-47 Electrical medical equipment - Part 2-47: Particular requirements relating to the essential safety and required performance of portable electrocardiograph systems (IEC 60601-2-47: 2012)

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

tst EN 80601-2-30 Electrical medical equipment - Part 2-30: Specific features for safety, including the required performance of noninvasive automatic repeat blood pressure monitoring equipment (IEC 80601-2-30: 2009 + Corrigendum 2010-01)

Electrical medical equipment - Part 80601-2: Particular requirements for the essential safety and required performance of noninvasive automatic repeated blood pressure monitoring equipment (IEC 30 / 1: 2)

tst EN 60601-2-10 Electrical medical equipment - Part 2-10: Specific requirements for essential safety and required performance of nerve and muscle stimulators (IEC 60601-2-10: 2012)

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

EN ISO 80601-2-55 Electrical and medical equipment - Part 2-55: Specific requirements for basic safety and required performance of respiratory gas monitors (ISO 80601-2-55: 2011)

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

EN ISO 80601-2-12 Electrical and medical equipment - Part 2-12: Specific requirements for the safety of lung fans - Intensive care fans (ISO / IEC 80601-2-12: 2011)

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

tst EN 60601-2-16 Electrical medical devices - Part 2-16: Particular requirements for essential safety and required performance of hemodialysis, hemodiafiltration and hemofiltration devices (IEC 60601-2-16: 2012)

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

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

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

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

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

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

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

TS EN ISO 13356 Surgical implants - Tetragonal zirconium oxide stabilized ceramic materials stabilized with yttrium oxide (Y-TZP)

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

TS EN ISO 80601-2-61Electrical medical equipment - Part 2-61: Specific requirements for the essential performance and essential safety of the pulse oximetry equipment for

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

80601-2-12 / tst AC Electrical equipment - Part 2-12: Particular requirements for the safety of lung fans - Intensive care fans - Technical Correction

80601-2-12 / AC Electrical medical equipment - Part 2-12: Specific requirements for the safety of lung fans - Intensive care fans

Electrical medical devices - Part 60601-2: Particular features for the safety of peritoneal dialysis devices

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

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

tst EN 60601-2-57 Electrical medical equipment - Part 2-57: Specific requirements for basic safety and required performance of laser-free devices for treatment, diagnosis, imaging and cosmetic / anesthetic use

tst EN 60601-2-22 Electrical medical devices - Part 2-22: Specific requirements for the safety of diagnostic and therapeutic laser devices (IEC 60601-2-22: 2007 + A1: 2012)

TS EN 60601-2-22 Electrical medical devices - Part 2-22: Specific features for the safety of diagnostic and therapeutic laser devices

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

TS EN ISO 81060-1 Non-Invasive Sphygmomanometer Section 1: General Features

TS EN ISO 8362-2 Injection containers and accessories - Part 2: Stoppers for injection vials

TS EN ISO 8362-1 / A1Injection cups and accessories - Part 1: Injection vials made of glass tubing

TS EN ISO 10079-1 Medical aspiration equipment - Section 1: Electrically operated aspiration equipment

TS EN 16128 Ophthalmic optics - Reference method for nickel release experiments of spectacle frames and sunglasses

TS EN 60601-1-2 Electrical and medical equipment - Part 1-2: General specifications for basic safety and performance - Complementary standard: Electromagnetic disturbances - Characteristics and tests

TS EN 62304 / A1 Medical device software - Software lifecycle processes

TS EN 61675-2 Radionuclide imaging devices - Characteristics and test conditions - Part 2: Gamma cameras for imaging with whole body and single photon emission computed tomography (SPECT)

TS EN ISO 8362-5 Injection containers and accessories - Part 5: Freeze-drying plugs for injection vials

TS EN ISO 80601-2-72Electrical medical equipment - Part 2-72: Specific requirements for the essential safety and required performance of ventilators for home patient care for ventilator-dependent patients

TS EN ISO 11810 Lasers and laser-related equipment - Classification and test method of laser resistance for surgical drapes and / or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition

TS 13702 Authorized Services - Devices Used in Dental Prosthesis Laboratory - Rules

TS EN ISO 8537 Insulin syringes - Disposable, sterile - with or without needles

TS 13713Authorized services - Medical imaging devices - Rules

TS EN ISO 5360 Anesthetic evaporators - Material-specific filling systems

TS EN ISO 14408 Trachea tubes designed for laser surgery - Features for marking and accompanying information

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

TS EN ISO 11197 Feeding units for medical environments

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

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

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

TS EN 60601-2-44 / A2Electrical medical equipment - Part 2-44: Specific requirements for basic safety and required performance of X-ray equipment for computed tomography

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

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

TS EN ISO 10685-2 Ophthalmic optics - Electronic catalog and identification of spectacle frames and sunglasses - Part 2: Business information (ISO 10685-2: 2016, Revised edition 2016-05-15)

TS EN ISO 7376Anesthesia and breathing equipment - Laryngoscopes for tracheal intubation

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

Tst EN ISO 7396-1 Medical gas piping systems - Part 1: Compressed medical gases and piping systems for vacuum (ISO 7396-1: 2016)

tst EN ISO 11197 Feed units for medical environments (ISO 11197: 2016)

TS EN ISO 10328 Prosthetics - Structural testing of lower limb prostheses - Requirements and test methods

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

TS ISO 5832-1 Surgical implants - Metallic materials - Part 1: Machined stainless steel

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

TS ISO 5832-12 / Cor 1Surgical implants - Metallic materials - Part 12: Formable cobalt - Chromium-Molybdenum alloy

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

TS ISO 12891-1 Retrieval and analysis of surgical implants - Part 1: Retrieval and handling

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

TS EN ISO 7864 Disposable sterile hypodermic needles - Requirements and test methods

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

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

TS EN ISO 14971 / D1Medical devices - Applying risk management to medical devices (ISO 14971: 2007; Revised edition 2007-10-01)

TS EN ISO 8536-13 Infusion equipment for medical use - Part 13: Disposable grade flow regulators with liquid contact

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

TS EN ISO 5364 Anesthesia and breathing apparatus - Oropharyngeal tubes

TS EN ISO 5366 Anesthesia and breathing apparatus - Tracheostomy tubes and fittings

TS EN 60601-2-3 / A1Electrical medical equipment - Part 2-3: Specific requirements for basic safety and required performance of short-wave therapy equipment

60601-2-6 / A1Electrical medical equipment - Part 2-6: Specific requirements for basic safety and required performance of microwave treatment equipment

TS ISO 13779-1 Surgical implants - Hydroxyapatite - Part 1: Ceramic hydroxyapatite

TS ISO 7206-2 / A1 Surgical implants - Partial and full hip joint prostheses - Part 2: Movable surfaces made of metal, ceramic and plastic materials

TS ISO 5835 Surgical implants - Metal bone screws with hexagonal head groove, spherical bottom face, asymmetrical thread - Dimensions

TS ISO 5838-1 Surgical implants - Metal bone nails and wires - Part 1: General requirements

TS ISO 8536-12 Infusion equipment for medical use - Part 12: Control valves

TS ISO 8536-12 / A1 Infusion equipment for medical use - Part 12: Control valves - Modified 1

TS EN ISO 5832-3 Surgical implants - Metallic materials - Part 3: Formable titanium 6-Aluminum 4-Vanadium alloy

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

TS EN ISO 80601-2-56Electrical medical equipment - Part 2-56: Specific requirements for basic safety and required performance of clinical thermometers for body temperature measurement

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

TS EN 60601-1-3 / A11Electrical medical devices - Part 1-3: General requirements for basic safety and required performance - Supplementary standard: Radiation protection in diagnostic x-ray equipment

Electrical medical equipment - Part 60601-2: Specific requirements for basic safety and required performance of medical diagnostic magnetic resonance equipment TS EN 33-12-2 / A33

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

TS EN ISO 15223-1 Medical devices - Symbols to be used on medical device labels, labeling and information provided - Part 1: General requirements

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

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

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

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

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

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

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

TS ISO 7206-4 / A1 Surgical implants - Partial and full hip joint prostheses - Part 4: Determination of strength characteristics and performance of stem femoral components - Modified 1