List of Harmonized Standards
Below the list of harmonized standards for medical device for your reference and search
For latest update check the official page.
| Title of the standard |
| EN 285:2006+A2:2009 Sterilization – Steam sterilizers – Large sterilizers |
| EN 455-1:2000 Medical gloves for single use – Part 1: Requirements and testing for freedom from holes |
| EN 455-2:2009+A2:2013 Medical gloves for single use – Part 2: Requirements and testing for physical properties |
| EN 455-3:2006 Medical gloves for single use – Part 3: Requirements and testing for biological evaluation |
| EN 455-4:2009 Medical gloves for single use – Part 4: Requirements and testing for shelf life determination |
| EN 556-1:2001 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 1: Requirements for terminally sterilized medical devices |
| EN 556-1:2001/AC:2006 |
| EN 556-2:2015 Sterilization of medical devices – Requirements for medical devices to be designated ”STERILE” – Part 2: Requirements for aseptically processed medical devices |
| EN 794-3:1998+A2:2009 Lung ventilators – Part 3: Particular requirements for emergency and transport ventilators |
| EN 1041:2008 Information supplied by the manufacturer of medical devices |
| EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers – Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
| EN 1060-4:2004 Non-invasive sphygmomanometers – Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers |
| EN ISO 1135-4:2011 Transfusion equipment for medical use – Part 4: Transfusion sets for single use (ISO 1135-4:2010) |
| EN 1282-2:2005+A1:2009 Tracheostomy tubes – Part 2: Paediatric tubes (ISO 5366-3:2001, modified) |
| EN 1422:1997+A1:2009 Sterilizers for medical purposes – Ethylene oxide sterilizers – Requirements and test methods |
| EN 1618:1997 Catheters other than intravascular catheters – Test methods for common properties |
| EN 1639:2009Dentistry – Medical devices for dentistry – Instruments |
| EN 1640:2009 Dentistry – Medical devices for dentistry – Equipment |
| EN 1641:2009 Dentistry – Medical devices for dentistry – Materials |
| EN 1642:2011 Dentistry – Medical devices for dentistry – Dental implants |
| EN 1707:1996 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment – Lock fittings |
| EN 1782:1998+A1:2009 Tracheal tubes and connectors |
| EN 1789:2007+A1:2010 Medical vehicles and their equipment – Road ambulances |
| EN 1820:2005+A1:2009 Anaesthetic reservoir bags (ISO 5362:2000, modified) |
| EN 1865-1:2010+A1:2015 Patient handling equipment used in road ambulances – Part 1: General stretcher systems and patient handling equipment |
| EN 1865-2:2010+A1:2015 Patient handling equipment used in road ambulances – Part 2: Power assisted stretcher |
| EN 1865-3:2012 Patient handling equipment used in road ambulances – Part 3: Heavy duty stretcher |
| EN 1865-4:2012 Patient handling equipment used in road ambulances – Part 4: Foldable patient transfer chair |
| EN 1865-5:2012 Patient handling equipment used in road ambulances – Part 5: Stretcher support |
| EN 1985:1998 Walking aids – General requirements and test methods |
| EN ISO 3826-2:2008 Plastics collapsible containers for human blood and blood components – Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008) |
| EN ISO 3826-3:2007 Plastics collapsible containers for human blood and blood components – Part 3: Blood bag systems with integrated features (ISO 3826-3:2006) |
| EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components – Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015) |
| EN ISO 4074:2002 Natural latex rubber condoms – Requirements and test methods (ISO 4074:2002) |
| EN ISO 4135:2001 Anaesthetic and respiratory equipment – Vocabulary (ISO 4135:2001) |
| EN ISO 5359:2008 Low-pressure hose assemblies for use with medical gases (ISO 5359:2008) |
| EN ISO 5359:2008/A1:2011 |
| EN ISO 5360:2009 Anaesthetic vaporizers – Agent-specific filling systems (ISO 5360:2006) |
| EN ISO 5366-1:2009 Anaesthetic and respiratory equipment – Tracheostomy tubes – Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000) |
| EN ISO 5840:2009 Cardiovascular implants – Cardiac valve prostheses (ISO 5840:2005) |
| EN ISO 7197:2009 Neurosurgical implants – Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007) |
| EN ISO 7376:2009 Anaesthetic and respiratory equipment – Laryngoscopes for tracheal intubation (ISO 7376:2009) |
| EN ISO 7396-1:2007 Medical gas pipeline systems – Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007) |
| EN ISO 7396-1:2007/A1:2010 |
| EN ISO 7396-1:2007/A2:2010 |
| EN ISO 7396-2:2007 Medical gas pipeline systems – Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) |
| EN ISO 7886-3:2009 Sterile hypodermic syringes for single use – Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005) |
| EN ISO 7886-4:2009 Sterile hypodermic syringes for single use – Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006) |
| EN ISO 8185:2009 Respiratory tract humidifiers for medical use – Particular requirements for respiratory humidification systems (ISO 8185:2007) |
| EN ISO 8359:2009 Oxygen concentrators for medical use – Safety requirements (ISO 8359:1996) |
| EN ISO 8359:2009/A1:2012 |
| EN ISO 8835-2:2009 Inhalational anaesthesia systems – Part 2: Anaesthetic breathing systems (ISO 8835-2:2007) |
| EN ISO 8835-3:2009 Inhalational anaesthesia systems – Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007) |
| EN ISO 8835-3:2009/A1:2010 |
| EN ISO 8835-4:2009 Inhalational anaesthesia systems – Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004) |
| EN ISO 8835-5:2009 Inhalational anaesthesia systems – Part 5: Anaesthetic ventilators (ISO 8835-5:2004) |
| EN ISO 9170-1:2008 Terminal units for medical gas pipeline systems – Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008) |
| EN ISO 9170-2:2008 Terminal units for medical gas pipeline systems – Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008) |
| EN ISO 9360-1:2009 Anaesthetic and respiratory equipment – Heat and moisture exchangers (HMEs) for humidifying respired gases in humans – Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000) |
| EN ISO 9360-2:2009 Anaesthetic and respiratory equipment – Heat and moisture exchangers (HMEs) for humidifying respired gases in humans – Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001) |
| EN ISO 9713:2009 Neurosurgical implants – Self-closing intracranial aneurysm clips (ISO 9713:2002) |
| EN ISO 10079-1:2009 Medical suction equipment – Part 1: Electrically powered suction equipment – Safety requirements (ISO 10079-1:1999) |
| EN ISO 10079-2:2009 Medical suction equipment – Part 2: Manually powered suction equipment (ISO 10079-2:1999) |
| EN ISO 10079-3:2009 Medical suction equipment – Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999) |
| EN ISO 10328:2016 (new)Prosthetics – Structural testing of lower-limb prostheses – Requirements and test methods (ISO 10328:2016) |
| EN ISO 10524-1:2006 Pressure regulators for use with medical gases – Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) |
| EN ISO 10524-2:2006 Pressure regulators for use with medical gases – Part 2: Manifold and line pressure regulators (ISO 10524-2:2005) |
| EN ISO 10524-3:2006 Pressure regulators for use with medical gases – Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005) |
| EN ISO 10524-4:2008 Pressure regulators for use with medical gases – Part 4: Low-pressure regulators (ISO 10524-4:2008) |
| EN ISO 10535:2006 Hoists for the transfer of disabled persons – Requirements and test methods (ISO 10535:2006) |
| EN ISO 10555-1:2009 Sterile, single-use intravascular catheters – Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004) |
| EN ISO 10651-2:2009 Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004) |
| EN ISO 10651-4:2009 Lung ventilators – Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) |
| EN ISO 10651-6:2009 Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 6: Home-care ventilatory support devices (ISO 10651-6:2004) |
| EN ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) |
| EN ISO 10993-1:2009/AC:2010 |
| EN ISO 10993-3:2014 Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) |
| EN ISO 10993-4:2009 Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006) |
| EN ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
| EN ISO 10993-6:2009 Biological evaluation of medical devices – Part 6: Tests for local effects after implantation (ISO 10993-6:2007) |
| EN ISO 10993-7:2008 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) |
| EN ISO 10993-7:2008/AC:2009 |
| EN ISO 10993-9:2009 Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) |
| EN ISO 10993-11:2009 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
| EN ISO 10993-12:2012 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
| EN ISO 10993-13:2010 Biological evaluation of medical devices – Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
| EN ISO 10993-14:2009 Biological evaluation of medical devices – Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) |
| EN ISO 10993-15:2009 Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) |
| EN ISO 10993-16:2010 Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010) |
| EN ISO 10993-17:2009 Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
| EN ISO 10993-18:2009 Biological evaluation of medical devices – Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
| EN ISO 11135-1:2007 Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) |
| EN ISO 11137-1:2015 Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
| EN ISO 11137-2:2015 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
| EN ISO 11138-2:2009 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) |
| EN ISO 11138-3:2009 Sterilization of health care products – Biological indicators – Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) |
| EN ISO 11140-1:2009 Sterilization of health care products – Chemical indicators – Part 1: General requirements (ISO 11140-1:2005) |
| EN ISO 11140-3:2009 Sterilization of health care products – Chemical indicators – Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007) |
| EN ISO 11197:2009 Medical supply units (ISO 11197:2004) |
| EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) |
| EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) |
| EN ISO 11737-1:2006 Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) |
| EN ISO 11737-1:2006/AC:2009 |
| EN ISO 11737-2:2009 Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) |
| EN ISO 11810-1:2009 Lasers and laser-related equipment – Test method and classification for the laser resistance of surgical drapes and/or patient protective covers – Part 1: Primary ignition and penetration (ISO 11810-1:2005) |
| EN ISO 11810-2:2009 Lasers and laser-related equipment – Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers – Part 2: Secondary ignition (ISO 11810-2:2007) |
| EN ISO 11979-8:2009 Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirements (ISO 11979-8:2006) |
| EN ISO 11990-1:2014 Lasers and laser-related equipment – Determination of laser resistance of tracheal tubes – Part 1: Tracheal tube shaft (ISO 11990-1:2011) |
| EN ISO 11990-2:2014 Lasers and laser-related equipment – Determination of laser resistance of tracheal tubes – Part 2: Tracheal tube cuffs (ISO 11990-2:2010) |
| EN 12006-2:1998+A1:2009 Non active surgical implants – Particular requirements for cardiac and vascular implants – Part 2: Vascular prostheses including cardiac valve conduits |
| EN 12006-3:1998+A1:2009 Non active surgical implants – Particular requirements for cardiac and vascular implants – Part 3: Endovascular devices |
| EN 12183:2009 Manual wheelchairs – Requirements and test methods |
| EN 12184:2009 Electrically powered wheelchairs, scooters and their chargers – Requirements and test methods |
| EN 12342:1998+A1:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators |
| EN 12470-1:2000+A1:2009 Clinical thermometers – Part 1: Metallic liquid-in-glass thermometers with maximum device |
| EN 12470-2:2000+A1:2009 Clinical thermometers – Part 2: Phase change type (dot matrix) thermometers |
| EN 12470-3:2000+A1:2009 Clinical thermometers – Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
| EN 12470-4:2000+A1:2009 Clinical thermometers – Part 4: Performance of electrical thermometers for continuous measurement |
| EN 12470-5:2003 Clinical thermometers – Part 5: Performance of infra-red ear thermometers (with maximum device) |
| EN ISO 12870:2009 Ophthalmic optics – Spectacle frames – Requirements and test methods (ISO 12870:2004) |
| EN 13060:2014Small steam sterilizers |
| EN ISO 13408-1:2015 Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| EN ISO 13408-2:2011 Aseptic processing of health care products – Part 2: Filtration (ISO 13408-2:2003) |
| EN ISO 13408-3:2011 Aseptic processing of health care products – Part 3: Lyophilization (ISO 13408-3:2006) |
| EN ISO 13408-4:2011 Aseptic processing of health care products – Part 4: Clean-in-place technologies (ISO 13408-4:2005) |
| EN ISO 13408-5:2011 Aseptic processing of health care products – Part 5: Sterilization in place (ISO 13408-5:2006) |
| EN ISO 13408-6:2011 Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2005) |
| EN ISO 13408-7:2015 Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012) |
| EN ISO 13485:2016 (new)Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) |
| This is the first publication |
| EN 13544-1:2007+A1:2009Respiratory therapy equipment – Part 1: Nebulizing systems and their components |
| EN 13544-2:2002+A1:2009Respiratory therapy equipment – Part 2: Tubing and connectors |
| EN 13544-3:2001+A1:2009Respiratory therapy equipment – Part 3: Air entrainment devices |
| EN 13624:2003 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area – Test method and requirements (phase 2, step 1) |
| EN 13718-1:2008 Medical vehicles and their equipment – Air ambulances – Part 1: Requirements for medical devices used in air ambulances |
| EN 13718-2:2015 Medical vehicles and their equipment – Air ambulances – Part 2: Operational and technical requirements for air ambulances |
| EN 13726-1:2002 Test methods for primary wound dressings – Part 1: Aspects of absorbency |
| EN 13726-1:2002/AC:2003 |
| EN 13726-2:2002 Test methods for primary wound dressings – Part 2: Moisture vapour transmission rate of permeable film dressings |
| EN 13727:2012 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of bactericidal activity in the medical area – Test method and requirements (phase 2, step 1) |
| EN 13867:2002+A1:2009 Concentrates for haemodialysis and related therapies |
| EN 13976-1:2011 Rescue systems – Transportation of incubators – Part 1: Interface conditions |
| EN 13976-2:2011 Rescue systems – Transportation of incubators – Part 2: System requirements |
| EN 14079:2003 Non-active medical devices – Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze |
| EN 14139:2010 Ophthalmic optics – Specifications for ready-to-wear spectacles |
| EN ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2011) |
| EN ISO 14155:2011/AC:2011 |
| EN 14180:2003+A2:2009 Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing |
| EN 14348:2005 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants – Test methods and requirements (phase 2, step 1) |
| EN ISO 14408:2009 Tracheal tubes designed for laser surgery – Requirements for marking and accompanying information (ISO 14408:2005) |
| EN 14561:2006 Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area – Test method and requirements (phase 2, step 2) |
| EN 14562:2006 Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area – Test method and requirements (phase 2, step 2) |
| EN 14563:2008 Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area – Test method and requirements (phase 2, step 2) |
| EN ISO 14602:2011 Non-active surgical implants – Implants for osteosynthesis – Particular requirements (ISO 14602:2010) |
| EN ISO 14607:2009 Non-active surgical implants – Mammary implants – Particular requirements (ISO 14607:2007) |
| EN ISO 14630:2009 Non-active surgical implants – General requirements (ISO 14630:2008) |
| EN 14683:2005 Surgical masks – Requirements and test methods |
| EN ISO 14889:2009 Ophthalmic optics – Spectacle lenses – Fundamental requirements for uncut finished lenses (ISO 14889:2003) |
| EN 14931:2006 Pressure vessels for human occupancy (PVHO) – Multi-place pressure chamber systems for hyperbaric therapy – Performance, safety requirements and testing |
| EN ISO 14937:2009 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 (ISO 14937:2009) |
| EN ISO 14971:2012 Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| EN ISO 15001:2011 Anaesthetic and respiratory equipment – Compatibility with oxygen (ISO 15001:2010) |
| EN ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) |
| EN ISO 15004-1:2009 Ophthalmic instruments – Fundamental requirements and test methods – Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006) |
| EN ISO 15223-1:2016 (new)Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03) |
| EN ISO 15747:2011 Plastic containers for intravenous injections (ISO 15747:2010) |
| EN ISO 15798:2010 Ophthalmic implants – Ophthalmic viscosurgical devices (ISO 15798:2010) |
| EN ISO 15883-1:2009 Washer-disinfectors – Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) |
| EN ISO 15883-2:2009 Washer-disinfectors – Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006) |
| EN ISO 15883-3:2009 Washer-disinfectors – Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006) |
| EN ISO 15883-4:2009 Washer-disinfectors – Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008) |
| EN 15986:2011 Symbol for use in the labelling of medical devices – Requirements for labelling of medical devices containing phthalates |
| EN ISO 16061:2009 Instrumentation for use in association with non-active surgical implants – General requirements (ISO 16061:2008, Corrected version 2009-03-15) |
| EN ISO 16201:2006 Technical aids for disabled persons – Environmental control systems for daily living (ISO 16201:2006) |
| EN ISO 17510-1:2009 Sleep apnoea breathing therapy – Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
| EN ISO 17510-2:2009 Sleep apnoea breathing therapy – Part 2: Masks and application accessories (ISO 17510-2:2007) |
| EN ISO 17664:2004 Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004) |
| EN ISO 17665-1:2006 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
| EN ISO 18777:2009 Transportable liquid oxygen systems for medical use – Particular requirements (ISO 18777:2005) |
| EN ISO 18778:2009 Respiratory equipment – Infant monitors – Particular requirements (ISO 18778:2005) |
| EN ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures – Particular requirements (ISO 18779:2005) |
| EN ISO 19054:2006 Rail systems for supporting medical equipment (ISO 19054:2005) |
| EN 20594-1:1993 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 1: General requirements (ISO 594-1:1986) |
| EN 20594-1:1993/A1:1997 |
| EN 20594-1:1993/AC:1996 |
| EN ISO 21534:2009Non-active surgical implants – Joint replacement implants – Particular requirements (ISO 21534:2007) |
| EN ISO 21535:2009Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants (ISO 21535:2007) |
| EN ISO 21536:2009Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants (ISO 21536:2007) |
| EN ISO 21649:2009Needle-free injectors for medical use – Requirements and test methods (ISO 21649:2006) |
| EN ISO 21969:2009High-pressure flexible connections for use with medical gas systems (ISO 21969:2009) |
| EN ISO 21987:2009Ophthalmic optics – Mounted spectacle lenses (ISO 21987:2009) |
| EN ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management (ISO 22442-1:2007) |
| EN ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007) |
| EN ISO 22442-3:2007 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 (ISO 22442-3:2007) |
| EN ISO 22523:2006 External limb prostheses and external orthoses – Requirements and test methods (ISO 22523:2006) |
| EN ISO 22675:2016 (new)Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods (ISO 22675:2016) |
| EN ISO 23328-1:2008 Breathing system filters for anaesthetic and respiratory use – Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003) |
| EN ISO 23328-2:2009 Breathing system filters for anaesthetic and respiratory use – Part 2: Non-filtration aspects (ISO 23328-2:2002) |
| EN ISO 23747:2009 Anaesthetic and respiratory equipment – Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007) |
| EN ISO 25539-1:2009 Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005) |
| EN ISO 25539-1:2009/AC:2011 |
| EN ISO 25539-2:2009 Cardiovascular implants – Endovascular devices – Part 2: Vascular stents (ISO 25539-2:2008) |
| EN ISO 25539-2:2009/AC:2011 |
| EN ISO 26782:2009 Anaesthetic and respiratory equipment – Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009) |
| EN ISO 25539-2:2009/AC:2011 |
| EN 27740:1992 Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) |
| EN 27740:1992/A1:1997 |
| EN 27740:1992/AC:1996 |
| EN ISO 81060-1:2012 Non-invasive sphygmomanometers – Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007) |
| EN 60118-13:2005 Electroacoustics – Hearing aids — Part 13: Electromagnetic compatibility (EMC) IEC 60118-13:2004 |
| EN 60522:1999 Determination of the permanent filtration of X-ray tube assemblies IEC 60522:1999 |
| EN 60580:2000 Medical electrical equipment – Dose area product meters IEC 60580:2000 |
| EN 60601-1:2006 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005 |
| EN 60601-1:2006/AC:2010 |
| EN 60601-1:2006/A1:2013 IEC 60601-1:2005/A1:2012 |
| EN 60601-1-1:2001 Medical electrical equipment – Part 1-1: General requirements for safety – Collateral standard: Safety requirements for medical electrical systems IEC 60601-1-1:2000 |
| EN 60601-1-2:2015 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests IEC 60601-1-2:2014 |
| EN 60601-1-3:2008 Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment IEC 60601-1-3:2008 |
| EN 60601-1-3:2008/AC:2010 |
| EN 60601-1-3:2008/A11:2016 |
| EN 60601-1-4:1996 Medical electrical equipment – Part 1-4: General requirements for safety – Collateral standard: Programmable electrical medical systems IEC 60601-1-4:1996 |
| EN 60601-1:2006/AC:2010 |
| EN 60601-1-6:2010 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability IEC 60601-1-6:2010 |
| EN 60601-1-8:2007 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 IEC 60601-1-8:2006 |
| EN 60601-1-8:2007/AC:2010 |
| EN 60601-1-8:2007/A11:2017 |
| EN 60601-1-10:2008 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 IEC 60601-1-10:2007 |
| EN 60601-1-11:2010 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 IEC 60601-1-11:2010 |
| EN 60601-2-1:1998 Medical electrical equipment – Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV IEC 60601-2-1:1998 |
| EN 60601-2-1:1998/A1:2002 IEC 60601-2-1:1998/A1:2002 |
| EN 60601-2-2:2009 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 IEC 60601-2-2:2009 |
| EN 60601-2-3:1993 Medical electrical equipment – Part 2: Particular requirements for the safety of short-wave therapy equipment IEC 60601-2-3:1991 |
| EN 60601-2-3:1993/A1:1998 IEC 60601-2-3:1991/A1:1998 |
| EN 60601-2-4:2003 Medical electrical equipment — Part 2-4: Particular requirements for the safety of cardiac defibrillators IEC 60601-2-4:2002 |
| EN 60601-2-5:2000 Medical electrical equipment – Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment IEC 60601-2-5:2000 |
| EN 60601-2-8:1997 Medical electrical equipment – Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV IEC 60601-2-8:1987 |
| EN 60601-2-8:1997/A1:1997 IEC 60601-2-8:1987/A1:199 |
| EN 60601-2-10:2000 Medical electrical equipment – Part 2-10: Particular requirements for the safety of nerve and muscle stimulators IEC 60601-2-10:1987 |
| EN 60601-2-10:2000/A1:2001 IEC 60601-2-10:1987/A1:2001 |
| EN 60601-2-11:1997 Medical electrical equipment – Part 2-11: Particular requirements for the safety of gamma beam therapy equipment IEC 60601-2-11:1997 |
| EN 60601-2-11:1997/A1:2004 IEC 60601-2-11:1997/A1:2004 |
| EN 60601-2-12:2006 Medical electrical equipment – Part 2-12: Particular requirements for the safety of lung ventilators – Critical care ventilators IEC 60601-2-12:2001 |
| EN 60601-2-13:2006 Medical electrical equipment – Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems IEC 60601-2-13:2003 |
| EN 60601-2-13:2006/A1:2007 IEC 60601-2-13:2003/A1:2006 |
| EN 60601-2-16:1998 Medical electrical equipment – Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment IEC 60601-2-16:1998 |
| EN 60601-2-16:1998/AC:1999 |
| EN 60601-2-17:2004 Medical electrical equipment – Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment IEC 60601-2-17:2004 |
| EN 60601-2-18:1996 Medical electrical equipment – Part 2: Particular requirements for the safety of endoscopic equipment IEC 60601-2-18:1996 |
| EN 60601-2-18:1996/A1:2000 IEC 60601-2-18:1996/A1:2000 |
| EN 60601-2-19:2009 Medical electrical equipment – Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators IEC 60601 IEC 60601-2-19:2009 |
| EN 60601-2-20:2009 Medical electrical equipment – Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators IEC 60601 IEC 60601-2-20:2009 |
| EN 60601-2-21:2009 Medical electrical equipment – Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers IEC 60601-2-21:2009 |
| EN 60601-2-22:1996 Medical electrical equipment – Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment IEC 60601-2-22:1995 |
| EN 60601-2-23:2000 Medical electrical equipment – Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment IEC 60601-2-23:1999 |
| EN 60601-2-24:1998 Medical electrical equipment – Part 2-24: Particular requirements for the safety of infusion pumps and controllers IEC 60601-2-24:1998 |
| EN 60601-2-25:1995 Medical electrical equipment – Part 2-25: Particular requirements for the safety of electrocardiographs IEC 60601-2-25:1993 |
| EN 60601-2-25:1995/A1:1999 IEC 60601-2-25:1993/A1:1999 |
| EN 60601-2-26:2003 Medical electrical equipment – Part 2-26: Particular requirements for the safety of electroencephalographs IEC 60601-2-26:2002 |
| EN 60601-2-27:2006 Medical electrical equipment – Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment IEC 60601-2-27:2005 |
| EN 60601-2-27:2006/AC:2006 |
| EN 60601-2-28:2010 Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis IEC 60601-2-28:2010 |
| EN 60601-2-29:2008 Medical electrical equipment – Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators IEC 60601-2-29:2008 |
| EN 60601-2-30:2000 Medical electrical equipment — Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment IEC 60601-2-30:1999 |
| EN 60601-2-33:2010 (new)Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis IEC 60601 IEC 60601-2-33:2010 |
| EN 60601-2-33:2010/A1:2015 IEC 60601-2-33:2010/A1:2013 |
| EN 60601-2-33:2010/A2:2015 IEC 60601-2-33:2010/A2:2015T |
| EN 60601-2-33:2010/AC:2016-03T |
| EN 60601-2-33:2010/A12:2016 |
| EN 60601-2-34:2000 Medical electrical equipment – Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment IEC 60601-2-34:2000 |
| EN 60601-2-36:1997 Medical electrical equipment – Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy IEC 60601-2-36:1997 |
| EN 60601-2-37:2008 Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment IEC 60601-2-37:2007 |
| EN 60601-2-39:2008 Medical electrical equipment – Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment IEC 60601-2-39:2007 |
| EN 60601-2-40:1998 Medical electrical equipment – Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment IEC 60601-2-40:1998 |
| EN 60601-2-41:2009 Medical electrical equipment – Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis IEC 60601-2-41:2009 |
| EN 60601-2-43:2010 Medical electrical equipment – Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures IEC 60601-2-43:2010 |
| EN 60601-2-44:2009 Medical electrical equipment – Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography IEC 60601-2-44:2009 |
| EN 60601-2-45:2001 Medical electrical equipment — Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices IEC 60601-2-45:2001 |
| EN 60601-2-46:1998 Medical electrical equipment — Part 2-46: Particular requirements for the safety of operating tables IEC 60601-2-46:1998 |
| EN 60601-2-47:2001 Medical electrical equipment – Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems IEC 60601-2-47:2001 |
| EN 60601-2-49:2001 Medical electrical equipment – Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment IEC 60601-2-49:2001 |
| EN 60601-2-50:2009 Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment IEC 60601-2-50:2009 |
| EN 60601-2-51:2003 Medical electrical equipment – Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs IEC 60601-2-51:2003 |
| EN 60601-2-52:2010 Medical electrical equipment – Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009) |
| 30/08/2012 |
| EN 60601-2-54:2009 Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy IEC 60601-2-54:2009 |
| EN 60627:2001 Diagnostic X-ray imaging equipment – Characteristics of general purpose and mammographic anti-scatter grids IEC 60627:2001 |
| EN 60627:2001/AC:2002 |
| EN 60645-1:2001 Electroacoustics – Audiological equipment – Part 1: Pure-tone audiometers IEC 60645-1:2001 |
| EN 60645-2:1997 Audiometers – Part 2: Equipment for speech audiometry IEC 60645-2:1993 |
| EN 60645-3:2007 Electroacoustics – Audiometric equipment – Part 3: Test signals of short duration IEC 60645-3:2007 |
| EN 60645-4:1995 Audiometers – Part 4: Equipment for extended high-frequency audiometry IEC 60645-4:1994 |
| EN 61217:2012 Radiotherapy equipment – Coordinates, movements and scales IEC 61217:2011 |
| EN 61676:2002 Medical electrical equipment – Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology IEC 61676:2002 |
| EN 61676:2002/A1:2009 IEC 61676:2002/A1:2008 |
| EN 62083:2009 Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems IEC 62083:2009 |
| EN 62220-1:2004 Medical electrical equipment – Characteristics of digital X-ray imaging devices – Part 1: Determination of the detective quantum efficiency IEC 62220-1:2003 |
| EN 62220-1-2:2007 Medical electrical equipment – Characteristics of digital X-ray imaging devices – Part 1-2: Determination of the detective quantum efficiency – Detectors used in mammography IEC 62220-1-2:2007 |
| EN 62220-1-3:2008 Medical electrical equipment – Characteristics of digital X-ray imaging devices – Part 1-3: Determination of the detective quantum efficiency – Detectors used in dynamic imaging IEC 62220-1-3:2008 |
| EN 62304:2006 Medical device software – Software life-cycle processes IEC 62304:2006 |
| EN 62304:2006/AC:2008 |
| EN 62366:2008 Medical devices – Application of usability engineering to medical devices IEC 62366:2007 |
| EN 80601-2-35:2009 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 IEC 80601-2-35:2009 |
| EN 80601-2-58:2009 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 IEC 80601-2-58:2008 |
| EN 80601-2-59:2009 Medical electrical equipment – Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening IEC 80601 IEC 80601-2-59:2008 |
