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MDD

来自认证百科
Admin（讨论 | 贡献）2020年3月22日 (日) 13:52的版本

MDD简介

欧盟为消除各成员国间的贸易壁垒，逐步建立成为一个统一的大市场，以确保人员、服务、资金和产品（如医疗器械）的自由流通。在医疗器械领域，欧盟委员会制定了三个欧盟指令，以替代原来各成员的认可体系，使有关这类产品投放市场的规定协调一致。 这三个指令分别是：

  • Medical devices Directive - MDD Directive 93/42/EEC
  • In vitro diagnostic medical devices - IVD Directive 98/79/EC
  • Active implantable medical devices - AIMD Directive 90/385/EEC 适用于心脏起搏器，可植入的胰岛素泵等有源植入性医疗器械。


Directive 93/42/EEC 医疗器械MDD指令

  • MDD医疗器械指令（MedicalDevicesDirective，93/42/EEC），适用范围很广，包括除有源植入性和体外诊断器械之外的几乎所有的医疗器械，如无源性医疗器械（敷料、一次性使用产品、接触镜、血袋、导管等）；以及有源性医疗器械，如核磁共振仪、超声诊断和治疗仪、输液泵等。该指令已于1995年1月1日生效，过渡截止日期为1998年6月13日从1998年6月14日起强制执行。

　　上述指令规定，在指令正式实施后，只有带有CE标志的医疗器械产品才能在欧盟市场上销售。


MDD Reference standard

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

Base: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169 of 12 July 1993

MDD是欧盟医疗器械93/42/EEC指令的简称，适用于在欧盟国家销售的医疗器械进行认证，是强制认证，需要由获得授权的公告机构进行认证。

MDD指令的产品分3个等级：一类，二类，三类，危险等级越高的产品划分的等级越高，认证就越严格，周期越长，费用越高。

标准更迭

MDD指令Directive 93/42/EEC将于在2020年5月26日将被，MDR指令REGULATION (EU) 2017/745替代

MDR指令

MDR指令REGULATION (EU) 2017/745

取自“https://iec.wiki/index.php?title=MDD&oldid=1089”