MDD Horizontal Harmonized Standards
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EN ISO 10993-1

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process more

EN ISO 10993-03

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity more

EN ISO 10993-04

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood more

EN ISO 10993-05

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity more

EN ISO 10993-06

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation more

EN ISO 10993-07

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals more

EN ISO 10993-09

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products more

EN ISO 10993-11

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity more

EN ISO 10993-12

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials more

EN ISO 10993-13

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices more

EN ISO 10993-14

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics more

EN ISO 10993-15

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys more

EN ISO 10993-16

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables more

EN ISO 10993-17

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances more

EN ISO 10993-18

Biological evaluation of medical devices - Part 18: Chemical characterization of materials more

EN ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice more

EN 1707

Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings more

EN ISO 5359

Low-pressure hose assemblies for use with medical gases more

EN ISO 7396-1

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum more

EN ISO 7396-2

Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems more

EN ISO 8359

Oxygen concentrators for medical use - Safety requirements more

EN ISO 9170-1

Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum more

EN ISO 9170-2

Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems more

EN ISO 10524-1

Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) more

EN ISO 10524-2

Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005) more

EN ISO 10524-4

Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008) more

EN ISO 10524-3

Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005) more

EN ISO 14630

Non-active surgical implants - General requirements more

EN 14931

Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing more

EN ISO 15002

Flow-metering devices for connection to terminal units of medical gas pipeline systems more

EN ISO 16061

Instrumentation for use in association with non-active surgical implants - General requirements more

EN ISO 18777

Transportable liquid oxygen systems for medical use - Particular requirements more

EN ISO 18779

Medical devices for conserving oxygen and oxygen mixtures - Particular requirements more

EN 20594-1

Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986) more

EN ISO 21969

High-pressure flexible connections for use with medical gas systems more

EN 27740

Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) more

EN 62304

Medical device software - Software life-cycle processes more

EN 62366

Medical devices - Application of usability engineering to medical devices more

EN 60580

Medical electrical equipment - Dose area product meters more

EN 60601-1

Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance more

EN 60601-1-10

Medical electrical equipment -- Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers more

EN 60601-1-11

Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment more

EN 60601-1-3

Medical electrical equipment -- Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment more

EN 60601-1-6

Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability more

EN 60601-1-8

Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems more

EN 60601-2-1

Medical electrical equipment -- Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV more

EN 60601-2-2

Medical electrical equipment -- Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories more

EN 60601-2-3

Medical electrical equipment -- Part 2: Particular requirements for the safety of short-wave therapy equipment more

EN 60601-2-4

Medical electrical equipment -- Part 2-4: Particular requirements for the safety of cardiac defibrillators more

EN 60601-2-5

Medical electrical equipment -- Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment more

EN 60601-2-8

Medical electrical equipment -- Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV more

EN 60601-2-10

Medical electrical equipment -- Part 2-10: Particular requirements for the safety of nerve and muscle stimulators more

EN 60601-2-11

Medical electrical equipment -- Part 2-11: Particular requirements for the safety of gamma beam therapy equipment more

EN 60601-2-12

Medical electrical equipment -- Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators more

EN 60601-2-13

Medical electrical equipment -- Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems more

EN 60601-2-16

Medical electrical equipment -- Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment more

EN 60601-2-17

Medical electrical equipment -- Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment more

EN 60601-2-18

Medical electrical equipment -- Part 2: Particular requirements for the safety of endoscopic equipment more

EN 60601-2-19

Medical electrical equipment -- Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators more

EN 60601-2-20

Medical electrical equipment -- Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators more

EN 60601-2-21

Medical electrical equipment -- Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers more

EN 60601-2-22

Medical electrical equipment -- Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment more

EN 60601-2-24

Medical electrical equipment -- Part 2-24: Particular requirements for the safety of infusion pumps and controllers more

EN 60601-2-25

Medical electrical equipment -- Part 2-25: Particular requirements for the safety of electrocardiographs more

EN 60601-2-26

Medical electrical equipment -- Part 2-26: Particular requirements for the safety of electroencephalographs more

EN 60601-2-27

Medical electrical equipment -- Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment more

EN 60601-2-28

Medical electrical equipment -- Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis more

EN 60601-2-29

Medical electrical equipment -- Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators more

EN 60601-2-30

Medical electrical equipment -- Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment more

EN 60601-2-33

Medical electrical equipment -- Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis more

EN 60601-2-34

Medical electrical equipment -- Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment more

EN 60601-2-35

Medical electrical equipment -- Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use more

EN 60601-2-36

Medical electrical equipment -- Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy more

EN 60601-2-37

Medical electrical equipment -- Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment more

EN 60601-2-38

Medical electrical equipment -- Part 2-38: Particular requirements for the safety of electrically operated hospital beds more

EN 60601-2-39

Medical electrical equipment -- Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment more

EN 60601-2-40

Medical electrical equipment -- Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment more

EN 60601-2-41

Medical electrical equipment -- Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis more

EN 60601-2-43

Medical electrical equipment -- Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures more

EN 60601-2-44

Medical electrical equipment -- Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography more

EN 60601-2-45

Medical electrical equipment -- Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices more

EN 60601-2-46

Medical electrical equipment -- Part 2-46: Particular requirements for the safety of operating tables more

EN 60601-2-47

Medical electrical equipment -- Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems more

EN 60601-2-49

Medical electrical equipment -- Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment more

EN 60601-2-50

Medical electrical equipment -- Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment more

EN 60601-2-51

Medical electrical equipment -- Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs more

EN 60601-2-52

Medical electrical equipment -- Part 2-52: Particular requirements for basic safety and essential performance of medical beds more

EN 60601-2-54

Medical electrical equipment -- Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy more

EN 62083

Medical electrical equipment -- Requirements for the safety of radiotherapy treatment planning systems more

EN 62220-1

Medical electrical equipment - Characteristics of digital X-ray imaging devices -- Part 1: Determination of the detective quantum efficiency more

EN 62220-1-2

Medical electrical equipment - Characteristics of digital X-ray imaging devices -- Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography more

EN 62220-1-3

Medical electrical equipment - Characteristics of digital X-ray imaging devices -- Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging more

EN 80601-2-35

Medical electrical equipment -- Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use more

EN 80601-2-58

Medical electrical equipment -- Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery more

EN 80601-2-59

Medical electrical equipment -- Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening more

EN 1041

Information supplied by the manufacturer of medical devices more

EN 15986

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates more

EN ISO 13408-1

Aseptic processing of health care products - Part 1: General requirements more

EN ISO 13408-2

Aseptic processing of health care products - Part 2: Filtration more

EN ISO 13408-3

Aseptic processing of health care products - Part 3: Lyophilization more

EN ISO 13408-6

Aseptic processing of health care products - Part 6: Isolator systems more

EN ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes more

EN ISO 14971

Medical devices - Application of risk management to medical devices more

EN ISO 22442-1

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management more

EN ISO 22442-2

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling more

EN ISO 22442-3

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents more

EN 285

Sterilization - Steam sterilizers - Large sterilizers more

EN 556-1

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices more

EN 556-2

terilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices more

EN 1422

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods more

EN ISO 11135-1

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices more

EN ISO 11137-1

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices more

EN ISO 11137-2

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose more

EN ISO 11138-3

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes more

EN ISO 11138-2

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes more

EN ISO 11140-1

Sterilization of health care products - Chemical indicators - Part 1: General requirements more

EN ISO 11140-3

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test more

EN ISO 11607-1

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems more

EN ISO 11607-2

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes more

EN ISO 11737-1

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products more

EN ISO 11737-2

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process more

EN 13624

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants more

EN 13727

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity more

EN 14180

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing more

EN 14348

hemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants more

EN 14561

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments more

EN 14562

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments more

EN 14563

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments more

EN ISO 14937

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices more

EN ISO 17664

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices more

EN ISO 17665-1

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices more