| 标准号 | 名称 | 采信 |
|---|
| EN 285 | Sterilization - Steam sterilizers - Large sterilizers | EU、UK |
| EN 455-1 | Medical gloves for single use - Part 1: Requirements and testing for freedom of holes | EU、UK |
| EN 455-2 | Medical gloves for single use - Part 2: Requirements and testing for physical properties | EU、UK |
| EN 455-3 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation | EU、UK |
| EN 455-4 | Medical gloves for single use - Part 4: Requirements and testing for shelf life determination | UK |
| EN 556-1 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - | EU、UK |
| EN 556-2 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - | EU、UK |
| EN 794-3 | Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators | UK |
| EN 1041 | Information supplied by the manufacturer of medical devices | UK |
| EN 1060-3 | Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood | UK |
| EN 1060-4 | Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accurac | UK |
| EN 1135-4 | Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (I | EU、UK |
| EN 1135-5 | Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure in | EU |
| EN 1282-2 | Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified) | UK |
| EN 1422 | Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods | UK |
| EN 1618 | Catheters other than intravascular catheters - Test methods for common properties | UK |
| EN 1639 | Dentistry - Medical devices for dentistry - Instruments | UK |
| EN 1640 | Dentistry - Medical devices for dentistry - Equipment | UK |
| EN 1641 | Dentistry - Medical devices for dentistry - Materials | UK |
| EN 1642 | Dentistry - Medical devices for dentistry - Dental implants | UK |
| EN 1707 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipme | UK |
| EN 1782 | Tracheal tubes and connectors | UK |
| EN 1789 | Medical vehicles and their equipment - Road ambulances | UK |
| EN 1820 | Anaesthetic reservoir bags (ISO 5362:2000, modified) | UK |
| EN 1865-1 | Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patie | UK |
| EN 1865-2 | Patient handling equipment used in ambulances - Part 2: Power assisted stretcher | EU、UK |
| EN 1865-3 | Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher | UK |
| EN 1865-4 | Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair | UK |
| EN 1865-5 | Patient handling equipment used in road ambulances - Part 5: Stretcher support | UK |
| EN 1865-6 | Patient handling equipment used in ambulances - Part 6: Powered chairs | EU、UK |
| EN 1985 | Walking aids - General requirements and test methods | UK |
| EN 3826-2 | Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols | UK |
| EN 3826-3 | Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems | UK |
| EN 3826-4 | Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood | UK |
| EN 4074 | Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002) | UK |
| EN 4135 | Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001) | UK |
| EN 5359 | Low-pressure hose assemblies for use with medical gases (ISO 5359:2008) | UK |
| EN 5360 | Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006) | UK |
| EN 5366-1 | Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for us | UK |
| EN 5840 | Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005) | UK |
| EN 7197 | Neurosurgical implants - Sterile, single-use hydrocephalus shunts (ISO 7197:2024) | EU、UK |
| EN 7376 | Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009) | UK |
| EN 7396-1 | Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum | UK |
| EN 7396-2 | Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2 | UK |
| EN 7886-3 | Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immuni | UK |
| EN 7886-4 | Sterile hypodermic syringes for single use - Part 4: Syringes with reuse prevention feature (ISO | UK |
| EN 8185 | Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidifi | UK |
| EN 8359 | Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996) | UK |
| EN 8835-3 | Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic | UK |
| EN 8835-4 | Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835- 4:2004 | UK |
| EN 8835-5 | Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004) | UK |
| EN 8835-2-2007 | Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835- 2:2007) | UK |
| EN 9170-1 | Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed | UK |
| EN 9170-2 | Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas sca | UK |
| EN 9360-1 | Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying resp | UK |
| EN 9360-2 | Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying resp | UK |
| EN 9713 | Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002) | UK |
| EN 10079-1 | Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements | UK |
| EN 10079-2 | Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999) | UK |
| EN 10079-3 | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source ( | UK |
| EN 10328 | Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 1 | UK |
| EN 10524-1 | Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regula | UK |
| EN 10524-2 | Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators ( | UK |
| EN 10524-3 | Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cyl | UK |
| EN 10524-4 | Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524- 4:2 | UK |
| EN 10535 | Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006) | UK |
| EN 10555-1 | Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, in | UK |
| EN 10651-2 | Lung ventilators for medical use - Particular requirements for basic safety and essential perfor | UK |
| EN 10651-4 | Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651 | UK |
| EN 10651-6 | Lung ventilators for medical use - Particular requirements for basic safety and essential perfor | UK |
| EN 10993-1 | Biological evaluation of medical devices - Part 1: Requirements and general principles for the e | EU、UK |
| EN 10993-3 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and r | UK |
| EN 10993-4 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with bloo | EU、UK |
| EN 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5: | EU、UK |
| EN 10993-6 | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (I | UK |
| EN 10993-7 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 1 | UK |
| EN 10993-9 | Biological evaluation of medical devices - Part 9: Framework for identification and quantificati | EU、UK |
| EN 10993-10 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2 | EU、UK |
| EN 10993-11 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:20 | UK |
| EN 10993-12 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials ( | EU、UK |
| EN 10993-13 | Biological evaluation of medical devices - Part 13: Identification and quantification of degrada | UK |
| EN 10993-14 | Biological evaluation of medical devices - Part 14: Identification and quantification of degrada | UK |
| EN 10993-15 | Biological evaluation of medical devices - Part 15: Identification and quantification of degrada | EU、UK |
| EN 10993-16 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation p | UK |
| EN 10993-17 | Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical dev | EU、UK |
| EN 10993-18 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device | EU、UK |
| EN 10993-23 | Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021) | EU、UK |
| EN 11135 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, valid | EU、UK |
| EN 11135-1 | Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, v | UK |
| EN 11137-1 | Sterilization of health care products - Radiation - Part 1: Requirements for development, valida | EU、UK |
| EN 11137-2 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose | EU、UK |
| EN 11138-2 | Sterilization of health care products - Biological indicators - Part 2: Biological indicators fo | UK |
| EN 11138-3 | Sterilization of health care products - Biological indicators - Part 3: Biological indicators fo | UK |
| EN 11140-1 | Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO | UK |
| EN 11140-3 | Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems | UK |
| EN 11197 | Medical supply units (ISO 11197:2004) | UK |
| EN 11607-1 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, steril | EU、UK |
| EN 11607-2 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for formin | EU、UK |
| EN 11608-7 | Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessi | UK |
| EN 11737-1 | Sterilization of health care products - Microbiological methods - Part 1: Determination of a pop | EU、UK |
| EN 11737-2 | Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility per | EU、UK |
| EN 11810-1 | Lasers and laser-related equipment - Test method and classification for the laser resistance of | UK |
| EN 11810-2 | Lasers and laser-related equipment - Test method and classification for the laser-resistance of | UK |
| EN 11979-8 | Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979- 8:2006) | UK |
| EN 11990 | Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft an | UK |
| EN 11990-1 | Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part | UK |
| EN 11990-2 | Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part | UK |
| EN 12006-2 | Non active surgical implants - Particular requirements for cardiac and vascular implants - Part | UK |
| EN 12006-3 | Non active surgical implants - Particular requirements for cardiac and vascular implants - Part | UK |
| EN 12183 | Manual wheelchairs - Requirements and test methods | UK |
| EN 12184 | Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods | UK |
| EN 12342 | Breathing tubes intended for use with anaesthetic apparatus and ventilators | UK |
| EN 12470-1 | Clinical thermometers - Part 1: Metallic liquid- in-glass thermometers with maximum device | UK |
| EN 12470-2 | Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers | UK |
| EN 12470-3 | Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive a | UK |
| EN 12470-4 | Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measuremen | UK |
| EN 12470-5 | Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device) | UK |
| EN 12870 | Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2024) | EU、UK |
| EN 13060 | Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing | EU、UK |
| EN 13408-1 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023) | EU、UK |
| EN 13408-2 | Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003) | UK |
| EN 13408-3 | Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006) | UK |
| EN 13408-4 | Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:20 | UK |
| EN 13408-5 | Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006) | UK |
| EN 13408-6 | Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021) | EU、UK |
| EN 13408-7 | Aseptic processing of health care products - Part 7: Alternative processes for medical devices a | UK |
| EN 13485 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2 | EU、UK |
| EN 13544-1 | Respiratory therapy equipment - Part 1: Nebulizing systems and their component | UK |
| EN 13544-2 | Respiratory therapy equipment - Part 2: Tubing and connectors | UK |
| EN 13544-3 | Respiratory therapy equipment - Part 3: Air entrainment devices | UK |
| EN 13624 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fung | UK |
| EN 13718-1 | Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices | UK |
| EN 13718-2 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requir | UK |
| EN 13726-1 | Test methods for primary wound dressings - Part 1: Aspects of absorbency | UK |
| EN 13726-2 | Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeabl | UK |
| EN 13727 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bact | UK |
| EN 13795-1 | Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns | EU、UK |
| EN 13795-2 | Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits | EU、UK |
| EN 13867 | Concentrates for haemodialysis and related therapies | UK |
| EN 13976-1 | Rescue systems - Transportation of incubators - Part 1: Interface conditions | UK |
| EN 13976-2 | Rescue systems - Transportation of incubators - Part 2: System requirements | UK |
| EN 14079 | Non-active medical devices - Performance requirements and test methods for absorbent cotton gauz | UK |
| EN 14139 | Ophthalmic optics - Specifications for ready-to- wear spectacles | UK |
| EN 14155 | Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155 | EU、UK |
| EN 14160 | Sterilization of health care products - Liquid chemical sterilizing agents for single-use medica | EU、UK |
| EN 14180 | Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirem | EU、UK |
| EN 14222 | Stainless steel steam boilers | EU |
| EN 14348 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of myco | UK |
| EN 14408 | Tracheal tubes designed for laser surgery - Requirements for marking and accompanying informatio | UK |
| EN 14561 | Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bacteri | UK |
| EN 14562 | Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungici | UK |
| EN 14563 | Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobac | UK |
| EN 14602 | Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602: | UK |
| EN 14607 | Non-active surgical implants - Mammary implants - Specific requirements (ISO 14607:2024) | EU、UK |
| EN 14630 | Non-active surgical implants - General requirements (ISO 14630:2024) | EU、UK |
| EN 14683 | Medical face masks - Requirements and test methods | EU、UK |
| EN 14889 | Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 1 | EU、UK |
| EN 14931 | Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbari | UK |
| EN 14937 | Sterilization of health care products - General requirements for characterization of a sterilizi | UK |
| EN 14971 | Medical devices - Application of risk management to medical devices (ISO 14971:2019) | EU、UK |
| EN 15001 | Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010) | UK |
| EN 15002 | Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 1500 | UK |
| EN 15004-1 | Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirement | UK |
| EN 15223-1 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part | EU、UK |
| EN 15747 | Plastic containers for intravenous injections (ISO 15747:2010) | UK |
| EN 15798 | Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010) | UK |
| EN 15883-1 | Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1 | EU、UK |
| EN 15883-2 | Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal d | EU、UK |
| EN 15883-3 | Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal d | EU、UK |
| EN 15883-4 | Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical | UK |
| EN 15883-7 | Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical | EU |
| EN 15986 | Symbol for use in the labelling of medical devices - Requirements for labelling of medical devic | UK |
| EN 16061 | Instrumentation for use in association with non- active surgical implants - General requirements | UK |
| EN 16201 | Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201: | UK |
| EN 17510-1 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2 | UK |
| EN 17510-2 | Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007) | UK |
| EN 17511 | In vitro diagnostic medical devices - Requirements for establishing metrological traceability of | EU |
| EN 17664 | Sterilization of medical devices - Information to be provided by the manufacturer for the proces | UK |
| EN 17664-1 | Processing of health care products - Information to be provided by the medical device manufactur | EU、UK |
| EN 17664-2 | Processing of health care products - Information to be provided by the medical device manufactur | EU、UK |
| EN 17665 | Sterilization of health care products - Moist heat - Requirements for the development, validatio | EU |
| EN 17665-1 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, v | UK |
| EN 18113-1 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Par | EU |
| EN 18113-2 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Par | EU |
| EN 18113-3 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Par | EU |
| EN 18113-4 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Par | EU |
| EN 18113-5 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Par | EU |
| EN 18562-1 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evalu | EU |
| EN 18562-2 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests | EU |
| EN 18562-3 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests | EU |
| EN 18562-4 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests | EU |
| EN 18777 | Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005) | UK |
| EN 18778 | Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005) | UK |
| EN 18779 | Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2 | UK |
| EN 19054 | Rail systems for supporting medical equipment (ISO 19054:2005) | UK |
| EN 20594-1 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipme | UK |
| EN 20916 | In vitro diagnostic medical devices - Clinical performance studies using specimens from human su | EU |
| EN 21534 | Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2 | UK |
| EN 21535 | Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint | EU、UK |
| EN 21536 | Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint | EU、UK |