The Complete List of Harmonized Standards for the Medical Device Directive (Linked to Official English Language Edition)
| Standard: | Title: |
|---|---|
| EN 285 | Sterilization - Steam sterilizers - Large sterilizers |
| EN 455-1 | Medical gloves for single use - Part 1: Requirements and testing for freedom from holes |
| EN 455-3 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| EN 455-4 | Medical gloves for single use - Part 4: Requirements and testing for shelf life determination |
| EN 556-1 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices |
| EN 556-2 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices |
| EN 794-3 | Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators |
| EN 1041 | Information supplied by the manufacturer of medical devices |
| EN 1060-3 | Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
| EN 1060-4 | Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers |
| EN 1282-2 | Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified) |
| EN 1422 | Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
| EN 1618 | Catheters other than intravascular catheters - Test methods for common properties |
| EN 1639 | Dentistry - Medical devices for dentistry - Instruments |
| EN 1640 | Dentistry - Medical devices for dentistry - Equipment |
| EN 1641 | Dentistry - Medical devices for dentistry - Materials |
| EN 1642 | Dentistry - Medical devices for dentistry - Dental implants |
| EN 1707 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings |
| EN 1782 | Tracheal tubes and connectors |
| EN 1789 | Medical vehicles and their equipment - Road ambulances |
| EN 1820 | Anaesthetic reservoir bags (ISO 5362:2000, modified) |
| EN 1865-3 | Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
| EN 1865-4 | Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair |
| EN 1865-5 | Patient handling equipment used in road ambulances - Part 5: Stretcher support |
| EN 1985 | Walking aids - General requirements and test methods |
| EN ISO 3826-2 | 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 | Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006) |
| EN ISO 4074 | Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002) |
| EN ISO 4135 | Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001) |
| EN ISO 5356-1 | Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2004) |
| EN ISO 5356-2 | Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2006) |
| EN ISO 5359 | Low-pressure hose assemblies for use with medical gases (ISO 5359:2008) |
| EN ISO 5360 | Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006) |
| EN ISO 5366-1 | Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000) |
| EN ISO 5840 | Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005) |
| EN ISO 7197 | Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007) |
| EN ISO 7376 | Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009) |
| EN ISO 7396-1 | Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007) |
| EN ISO 7396-2 | Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) |
| EN ISO 7886-3 | Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005) |
| EN ISO 7886-4 | Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006) |
| EN ISO 8185 | Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007) |
| EN ISO 8359 | Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996) |
| EN ISO 8835-2 | Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007) |
| EN ISO 8835-3 | Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007) |
| EN ISO 8835-4 | Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004) |
| EN ISO 8835-5 | Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004) |
| EN ISO 9170-1 | 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 | Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008) |
| EN ISO 9360-1 | 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 | 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 | Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002) |
| EN ISO 10079-1 | Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999) |
| EN ISO 10079-2 | Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999) |
| EN ISO 10079-3 | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999) |
| EN ISO 10328 | Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006) |
| 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) |
| EN ISO 10524-2 | Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005) |
| EN ISO 10524-3 | Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005) |
| EN ISO 10524-4 | Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008) |
| EN ISO 10535 | Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006) |
| EN ISO 10555-1 | 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 | 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 | Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) |
| EN ISO 10651-6 | 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 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) |
| EN ISO 10993-3 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003) |
| EN ISO 10993-4 | 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 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
| EN ISO 10993-6 | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007) |
| EN ISO 10993-7 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) |
| EN ISO 10993-9 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) |
| EN ISO 10993-11 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
| EN ISO 10993-12 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007) |
| EN ISO 10993-13 | 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 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) |
| EN ISO 10993-15 | 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 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010) |
| EN ISO 10993-17 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
| EN ISO 10993-18 | Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
| 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 (ISO 11135-1:2007) |
| 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 (ISO 11137-1:2006) |
| EN ISO 11137-2 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01) |
| EN ISO 11138-2 | Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) |
| EN ISO 11138-3 | Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) |
| EN ISO 11140-1 | Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005) |
| 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 (ISO 11140-3:2007, including Cor 1:2007) |
| EN ISO 11197 | Medical supply units (ISO 11197:2004) |
| EN ISO 11607-1 | 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 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) |
| EN ISO 11737-1 | Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) |
| 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 (ISO 11737-2:2009) |
| EN ISO 11810-1 | 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 | 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 | Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006) |
| EN 12006-2 | Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits |
| EN 12183 | Manual wheelchairs - Requirements and test methods |
| EN 12184 | Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods |
| EN 12342 | Breathing tubes intended for use with anaesthetic apparatus and ventilators |
| EN 12470-1 | Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device |
| EN 12470-2 | Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers |
| EN 12470-3 | Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
| EN 12470-4 | Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement |
| EN 12470-5 | Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device) |
| EN ISO 12870 | Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004) |
| EN 13060 | Small steam sterilizers |
| EN ISO 13408-1 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008) |
| EN ISO 13408-2 | Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003) |
| EN ISO 13408-3 | Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006) |
| EN ISO 13408-4 | Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005) |
| EN ISO 13408-5 | Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006) |
| EN ISO 13408-6 | Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005) |
| EN ISO 13485 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) |
| EN 13544-1 | Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
| EN 13544-2 | Respiratory therapy equipment - Part 2: Tubing and connectors |
| EN 13544-3 | Respiratory therapy equipment - Part 3: Air entrainment devices |
| EN 13624 | 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 | Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances |
| EN 13726-1 | Test methods for primary wound dressings - Part 1: Aspects of absorbency |
| EN 13726-2 | Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings |
| EN 13727 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1) |
| EN 13867 | Concentrates for haemodialysis and related therapies |
| EN 13976-1 | Rescue systems - Transportation of incubators - Part 1: Interface conditions |
| EN 13976-2 | Rescue systems - Transportation of incubators - Part 2: System requirements |
| EN 14079 | Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze |
| EN 14139 | Ophthalmic optics - Specifications for ready-to-wear spectacles |
| EN ISO 14155 | Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011) |
| EN 14180 | Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
| EN 14348 | 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 | Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005) |
| EN 14561 | 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 | 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 | 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 | Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010) |
| EN ISO 14607 | Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007) |
| EN ISO 14630 | Non-active surgical implants - General requirements (ISO 14630:2008) |
| EN 14683 | Surgical masks - Requirements and test methods |
| EN ISO 14889 | Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003) |
| EN 14931 | Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing |
| 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 (ISO 14937:2009) |
| EN ISO 14971 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| EN ISO 15001 | Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010) |
| EN ISO 15002 | Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) |
| EN ISO 15004-1 | Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006) |
| EN ISO 15747 | Plastic containers for intravenous injections (ISO 15747:2010) |
| EN ISO 15798 | Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010) |
| EN ISO 15883-1 | Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) |
| EN ISO 15883-2 | 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 | 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 | Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008) |
| EN 15986 | Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
| EN ISO 16061 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15) |
| EN ISO 16201 | Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006) |
| EN ISO 17510-1 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
| EN ISO 17510-2 | Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007) |
| EN ISO 17664 | 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 | 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 | Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005) |
| EN ISO 18778 | Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005) |
| EN ISO 18779 | Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005) |
| EN ISO 19054 | Rail systems for supporting medical equipment (ISO 19054:2005) |
| 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) |
| EN ISO 21171 | Medical gloves - Determination of removable surface powder (ISO 21171:2006) |
| EN ISO 21534 | Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007) |
| EN ISO 21535 | Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007) |
| EN ISO 21536 | Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007) |
| EN ISO 21649 | Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) |
| EN ISO 21969 | High-pressure flexible connections for use with medical gas systems (ISO 21969:2009) |
| EN ISO 21987 | Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2009) |
| EN ISO 22442-1 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007) |
| EN ISO 22442-2 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007) |
| 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 (ISO 22442-3:2007) |
| EN ISO 22523 | External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) |
| EN ISO 22610 | Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006) |
| EN ISO 22612 | Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005) |
| EN ISO 22675 | Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2006) |
| EN ISO 23328-1 | 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 | Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002) |
| EN ISO 23747 | 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 | Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005) |
| EN ISO 25539-2 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008) |
| EN ISO 26782 | Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009) |
| EN 27740 | Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) |
| EN ISO 81060-1 | Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007) |
| EN 60118-13 | Electroacoustics - Hearing aids -- Part 13: Electromagnetic compatibility (EMC) IEC 60118-13:2004 |
| EN 60522 | Determination of the permanent filtration of X-ray tube assemblies IEC 60522:1999 |
| EN 60580 | Medical electrical equipment - Dose area product meters IEC 60580:2000 |
| EN 60601-1 | Medical electrical equipment -- Part 1: General requirements for safety IEC 60601-1:2005 |
| EN 60601-1-2 | Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests IEC 60601-1-2:2007 (Modified) |
| 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 IEC 60601-1-3:2008 |
| EN 60601-1-6 | 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 | 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 60601-1-10 | 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 IEC 60601-1-10:2007 |
| 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 IEC 60601-1-11:2010 |
| 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 IEC 60601-2-1:1998 |
| 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 IEC 60601-2-2:2009 |
| EN 60601-2-3 | Medical electrical equipment -- Part 2: Particular requirements for the safety of short-wave therapy equipment IEC 60601-2-3:1991 |
| EN 60601-2-4 | Medical electrical equipment -- Part 2-4: Particular requirements for the safety of cardiac defibrillators IEC 60601-2-4:2002 |
| EN 60601-2-5 | Medical electrical equipment -- Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment IEC 60601-2-5:2000 |
| 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 IEC 60601-2-8:1987 |
| EN 60601-2-10 | Medical electrical equipment -- Part 2-10: Particular requirements for the safety of nerve and muscle stimulators IEC 60601-2-10:1987 |
| EN 60601-2-11 | Medical electrical equipment -- Part 2-11: Particular requirements for the safety of gamma beam therapy equipment IEC 60601-2-11:1997 |
| EN 60601-2-12 | 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 | Medical electrical equipment -- Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems IEC 60601-2-13:2003 |
| EN 60601-2-16 | Medical electrical equipment -- Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment IEC 60601-2-16:1998 |
| EN 60601-2-17 | 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 | Medical electrical equipment -- Part 2: Particular requirements for the safety of endoscopic equipment IEC 60601-2-18:1996 |
| EN 60601-2-19 | Medical electrical equipment -- Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators IEC 60601-2-19:2009 |
| EN 60601-2-20 | Medical electrical equipment -- Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators IEC 60601-2-20:2009 |
| EN 60601-2-21 | 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 | 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 | 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 | 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 | Medical electrical equipment -- Part 2-25: Particular requirements for the safety of electrocardiographs IEC 60601-2-25:1993 |
| EN 60601-2-26 | Medical electrical equipment -- Part 2-26: Particular requirements for the safety of electroencephalographs IEC 60601-2-26:2002 |
| EN 60601-2-27 | Medical electrical equipment -- Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment IEC 60601-2-27:2005 |
| EN 60601-2-28 | 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 | 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 | 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 | Medical electrical equipment -- Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis IEC 60601-2-33:2002 |
| EN 60601-2-34 | 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 60601-2-35 | Medical electrical equipment -- Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use IEC 60601-2-35:1996 |
| EN 60601-2-36 | 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 | 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 60601-2-38 | Medical electrical equipment -- Part 2-38: Particular requirements for the safety of electrically operated hospital beds IEC 60601-2-38:1996 |
| EN 60601-2-39 | 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 | 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 | 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 | 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 | 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 | 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 | Medical electrical equipment -- Part 2-46: Particular requirements for the safety of operating tables IEC 60601-2-46:1998 |
| EN 60601-2-47 | 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 | 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 | 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 | 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 | Medical electrical equipment -- Part 2-52: Particular requirements for basic safety and essential performance of medical beds IEC 60601-2-52:2009 |
| 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 IEC 60601-2-54:2009 |
| EN 60627 | Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids IEC 60627:2001 |
| EN 60645-1 | Electroacoustics - Audiological equipment -- Part 1: Pure-tone audiometers IEC 60645-1:2001 |
| EN 60645-2 | Audiometers -- Part 2: Equipment for speech audiometry IEC 60645-2:1993 |
| EN 60645-3 | Electroacoustics - Audiometric equipment -- Part 3: Test signals of short duration IEC 60645-3:2007 |
| EN 60645-4 | Audiometers -- Part 4: Equipment for extended high-frequency audiometry IEC 60645-4:1994 |
| EN 61217 | Radiotherapy equipment - Coordinates, movements and scales IEC 61217:1996 |
| EN 61676 | Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology IEC 61676:2002 |
| EN 62083 | Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems IEC 62083:2009 |
| EN 62220-1 | 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 | 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 | 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 | Medical device software - Software life-cycle processes IEC 62304:2006 |
| EN 62366 | Medical devices - Application of usability engineering to medical devices IEC 62366:2007 |
| 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 IEC 80601-2-35:2009 |
| 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 IEC 80601-2-58:2008 |
| 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 IEC 80601-2-59:2008 |