{
  "url": "https://openlegislation.uk/eu-decision-2020-437/annex-I",
  "json_url": "https://openlegislation.uk/eu-decision-2020-437/annex-I.json",
  "legislation": "eudn/2020/437",
  "legislation_title": "Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC",
  "legislation_url": "https://openlegislation.uk/eu-decision-2020-437",
  "path": "annex/I",
  "kind": "annex",
  "number": "I",
  "heading": null,
  "text": "No\nReference of the standard\n1.\nEN 285:2006+A2:2009\nSterilization - Steam sterilizers - Large sterilizers\n2.\nEN 455-1:2000\nMedical gloves for single use - Part 1: Requirements and testing for freedom from holes\n3.\nEN 455-2:2009+A2:2013\nMedical gloves for single use - Part 2: Requirements and testing for physical properties\n4.\nEN 455-3:2006\nMedical gloves for single use - Part 3: Requirements and testing for biological evaluation\n5.\nEN 455-4:2009\nMedical gloves for single use - Part 4: Requirements and testing for shelf life determination\n6.\nEN 556-1:2001\nSterilization of medical devices - Requirements for medical devices to be designated \"STERILE\" - Part 1: Requirements for terminally sterilized medical devices\nEN 556-1:2001/AC:2006\n7.\nEN 556-2:2015\nSterilization of medical devices - Requirements for medical devices to be designated \"STERILE\" - Part 2: Requirements for aseptically processed medical devices\n8.\nEN 794-3:1998+A2:2009\nLung ventilators - Part 3: Particular requirements for emergency and transport ventilators\n9.\nEN 1041:2008\nInformation supplied by the manufacturer of medical devices\n10.\nEN 1060-3:1997+A2:2009\nNon-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems\n11.\nEN 1060-4:2004\nNon-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers\n12.\nEN ISO 1135-4:2011\nTransfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010)\n13.\nEN 1282-2:2005+A1:2009\nTracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)\n14.\nEN 1422:1997+A1:2009\nSterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods\n15.\nEN 1618:1997\nCatheters other than intravascular catheters - Test methods for common properties\n16.\nEN 1639:2009\nDentistry - Medical devices for dentistry - Instruments\n17.\nEN 1640:2009\nDentistry - Medical devices for dentistry - Equipment\n18.\nEN 1641:2009\nDentistry - Medical devices for dentistry - Materials\n19.\nEN 1642:2011\nDentistry - Medical devices for dentistry - Dental implants\n20.\nEN 1707:1996\nConical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings\n21.\nEN 1782:1998+A1:2009\nTracheal tubes and connectors\n22.\nEN 1789:2007+A1:2010\nMedical vehicles and their equipment - Road ambulances\n23.\nEN 1820:2005+A1:2009\nAnaesthetic reservoir bags (ISO 5362:2000, modified)\n24.\nEN 1865-1:2010+A1:2015\nPatient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment\n25.\nEN 1865-2:2010+A1:2015\nPatient handling equipment used in road ambulances - Part 2: Power assisted stretcher\n26.\nEN 1865-3:2012\nPatient handling equipment used in road ambulances - Part 3: Heavy duty stretcher\n27.\nEN 1865-4:2012\nPatient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair\n28.\nEN 1865-5:2012\nPatient handling equipment used in road ambulances - Part 5: Stretcher support\n29.\nEN 1985:1998\nWalking aids - General requirements and test methods\nNotice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant essential requirements of the amended directive are appropriately covered.\n30.\nEN ISO 3826-2:2008\nPlastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008)\n31.\nEN ISO 3826-3:2007\nPlastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826- 3:2006)\n32.\nEN ISO 3826-4:2015\nPlastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)\n33.\nEN ISO 4074:2002\nNatural latex rubber condoms - Requirements and test methods (ISO 4074:2002)\n34.\nEN ISO 4135:2001\nAnaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)\n35.\nEN ISO 5359:2008\nLow-pressure hose assemblies for use with medical gases (ISO 5359:2008)\nEN ISO 5359:2008/A1:2011\n36.\nEN ISO 5360:2009\nAnaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)\n37.\nEN ISO 5366-1:2009\nAnaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)\n38.\nEN ISO 5840:2009\nCardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)\n39.\nEN ISO 7197:2009\nNeurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)\n40.\nEN ISO 7376:2009\nAnaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)\n41.\nEN ISO 7396-1:2007\nMedical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)\nEN ISO 7396-1:2007/A1:2010\nEN ISO 7396-1:2007/A2:2010\n42.\nEN ISO 7396-2:2007\nMedical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)\n43.\nEN ISO 7886-3:2009\nSterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)\n44.\nEN ISO 7886-4:2009\nSterile hypodermic syringes for single use - Part 4: Syringes with reuse prevention feature (ISO 7886-4:2006)\n45.\nEN ISO 8185:2009\nRespiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)\n46.\nEN ISO 8359:2009\nOxygen concentrators for medical use - Safety requirements (ISO 8359:1996)\nEN ISO 8359:2009/A1:2012\n47.\nEN ISO 8835-2:2009\nInhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835- 2:2007)\n48.\nEN ISO 8835-3:2009\nInhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)\nEN ISO 8835-3:2009/A1:2010\n49.\nEN ISO 8835-4:2009\nInhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835- 4:2004)\n50.\nEN ISO 8835-5:2009\nInhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)\n51.\nEN ISO 9170-1:2008\nTerminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008)\n52.\nEN ISO 9170-2:2008\nTerminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)\n53.\nEN ISO 9360-1:2009\nAnaesthetic 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)\n54.\nEN ISO 9360-2:2009\nAnaesthetic 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)\n55.\nEN ISO 9713:2009\nNeurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)\n56.\nEN ISO 10079-1:2009\nMedical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)\n57.\nEN ISO 10079-2:2009\nMedical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)\n58.\nEN ISO 10079-3:2009\nMedical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)\n59.\nEN ISO 10328:2016\nProsthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)\n60.\nEN ISO 10524-1:2006\nPressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524- 1:2006)\n61.\nEN ISO 10524-2:2006\nPressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)\n62.\nEN ISO 10524-3:2006\nPressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)\n63.\nEN ISO 10524-4:2008\nPressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524- 4:2008)\n64.\nEN ISO 10535:2006\nHoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)\nNotice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant essential requirements of the amended directive are appropriately covered.\n65.\nEN ISO 10555-1:2009\nSterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)\n66.\nEN ISO 10651-2:2009\nLung 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)\n67.\nEN ISO 10651-4:2009\nLung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)\n68.\nEN ISO 10651-6:2009\nLung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)\n69.\nEN ISO 10993-1:2009\nBiological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)\nEN ISO 10993-1:2009/AC:2010\n70.\nEN ISO 10993-3:2014\nBiological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)\n71.\nEN ISO 10993-4:2009\nBiological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)\n72.\nEN ISO 10993-5:2009\nBiological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)\n73.\nEN ISO 10993-6:2009\nBiological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)\n74.\nEN ISO 10993-7:2008\nBiological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)\nEN ISO 10993-7:2008/AC:2009\n75.\nEN ISO 10993-9:2009\nBiological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)\n76.\nEN ISO 10993-11:2018\nBiological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)\n77.\nEN ISO 10993-12:2012\nBiological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)\n78.\nEN ISO 10993-13:2010\nBiological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)\n79.\nEN ISO 10993-14:2009\nBiological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)\n80.\nEN ISO 10993-15:2009\nBiological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)\n81.\nEN ISO 10993-16:2010\nBiological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)\n82.\nEN ISO 10993-17:2009\nBiological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)\n83.\nEN ISO 10993-18:2009\nBiological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)\n84.\nEN ISO 11135-1:2007\nSterilization 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)\n85.\nEN ISO 11137-1:2015\nSterilization 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)\nEN ISO 11137-1:2015/A2:2019\n86.\nEN ISO 11137-2:2015\nSterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)\n87.\nEN ISO 11138-2:2009\nSterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)\n88.\nEN ISO 11138-3:2009\nSterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)\n89.\nEN ISO 11140-1:2009\nSterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)\n90.\nEN ISO 11140-3:2009\nSterilization 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)\n91.\nEN ISO 11197:2009\nMedical supply units (ISO 11197:2004)\n92.\nEN ISO 11607-1:2009\nPackaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)\n93.\nEN ISO 11607-2:2006\nPackaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)\n94.\nEN ISO 11608-7:2017\nNeedle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)\n95.\nEN ISO 11737-1:2006\nSterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)\nEN ISO 11737-1:2006/AC:2009\n96.\nEN ISO 11737-2:2009\nSterilization 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)\n97.\nEN ISO 11810-1:2009\nLasers 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)\n98.\nEN ISO 11810-2:2009\nLasers 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)\n99.\nEN ISO 11979-8:2009\nOphthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979- 8:2006)\n100.\nEN ISO 11990:2018\nLasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO 11990:2018)\n101.\nEN 12006-2:1998+A1:2009\nNon active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits\n102.\nEN 12006-3:1998+A1:2009\nNon active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices\n103.\nEN 12183:2009\nManual wheelchairs - Requirements and test methods\n104.\nEN 12184:2009\nElectrically powered wheelchairs, scooters and their chargers - Requirements and test methods\n105.\nEN 12342:1998+A1:2009\nBreathing tubes intended for use with anaesthetic apparatus and ventilators\n106.\nEN 12470-1:2000+A1:2009\nClinical thermometers - Part 1: Metallic liquid- in-glass thermometers with maximum device\n107.\nEN 12470-2:2000+A1:2009\nClinical thermometers - Part 2: Phase change type (dot matrix) thermometers\n108.\nEN 12470-3:2000+A1:2009\nClinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device\n109.\nEN 12470-4:2000+A1:2009\nClinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement\n110.\nEN 12470-5:2003\nClinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)\nNotice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant essential requirements of the amended directive are appropriately covered.\n111.\nEN ISO 12870:2009\nOphthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004)\n112.\nEN 13060:2014\nSmall steam sterilizers\n113.\nEN ISO 13408-1:2015\nAseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)\n114.\nEN ISO 13408-2:2018\nAseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)\n115.\nEN ISO 13408-3:2011\nAseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)\n116.\nEN ISO 13408-4:2011\nAseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)\n117.\nEN ISO 13408-5:2011\nAseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)\n118.\nEN ISO 13408-6:2011\nAseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)\n119.\nEN ISO 13408-7:2015\nAseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)\n120.\nEN ISO 13485:2016\nMedical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)\nEN ISO 13485:2016/AC:2018\n121.\nEN 13544-1:2007+A1:2009\nRespiratory therapy equipment - Part 1: Nebulizing systems and their component\n122.\nEN 13544-2:2002+A1:2009\nRespiratory therapy equipment - Part 2: Tubing and connectors\n123.\nEN 13544-3:2001+A1:2009\nRespiratory therapy equipment - Part 3: Air entrainment devices\n124.\nEN 13624:2003\nChemical 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)\n125.\nEN 13718-1:2008\nMedical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances\n126.\nEN 13718-2:2015\nMedical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances\n127.\nEN 13726-1:2002\nTest methods for primary wound dressings - Part 1: Aspects of absorbency\nEN 13726-1:2002/AC:2003\n128.\nEN 13726-2:2002\nTest methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings\n129.\nEN 13727:2012\nChemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)\n130.\nEN 13795-1:2019\nSurgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns\n131.\nEN 13795-2:2019\nSurgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits\n132.\nEN 13867:2002+A1:2009\nConcentrates for haemodialysis and related therapies\n133.\nEN 13976-1:2011\nRescue systems - Transportation of incubators - Part 1: Interface conditions\n134.\nEN 13976-2:2018\nRescue systems - Transportation of incubators - Part 2: System requirements\n135.\nEN 14079:2003\nNon-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze\n136.\nEN 14139:2010\nOphthalmic optics - Specifications for ready-to- wear spectacles\n137.\nEN ISO 14155:2011\nClinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)\nEN ISO 14155:2011/AC:2011\n138.\nEN 14180:2003+A2:2009\nSterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing\n139.\nEN 14348:2005\nChemical 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)\n140.\nEN ISO 14408:2009\nTracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)\n141.\nEN 14561:2006\nChemical 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)\n142.\nEN 14562:2006\nChemical 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)\n143.\nEN 14563:2008\nChemical 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)\n144.\nEN ISO 14602:2011\nNon-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)\n145.\nEN ISO 14607:2009\nNon-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)\n146.\nEN ISO 14630:2009\nNon-active surgical implants - General requirements (ISO 14630:2008)\n147.\nEN 14683:2019+AC:2019\nMedical face masks - Requirements and test methods\n148.\nEN ISO 14889:2009\nOphthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)\n149.\nEN 14931:2006\nPressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing\n150.\nEN ISO 14937:2009\nSterilization 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)\n151.\nEN ISO 14971:2012\nMedical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)\n152.\nEN ISO 15001:2011\nAnaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)\n153.\nEN ISO 15002:2008\nFlow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)\n154.\nEN ISO 15004-1:2009\nOphthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)\n155.\nEN ISO 15223-1:2016\nMedical 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)\n156.\nEN ISO 15747:2019\nPlastic containers for intravenous injections (ISO 15747:2018)\n157.\nEN ISO 15798:2010\nOphthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)\n158.\nEN ISO 15883-1:2009\nWasher-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)\n159.\nEN ISO 15883-2:2009\nWasher-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)\n160.\nEN ISO 15883-3:2009\nWasher-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)\n161.\nEN ISO 15883-4:2018\nWasher-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018)\n162.\nEN 15986:2011\nSymbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalate\n163.\nEN ISO 16061:2009\nInstrumentation for use in association with non- active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03- 15)\n164.\nEN ISO 16201:2006\nTechnical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006)\n165.\nEN ISO 17510-1:2009\nSleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)\n166.\nEN ISO 17510-2:2009\nSleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)\n167.\nEN ISO 17664:2017\nProcessing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)\n168.\nEN ISO 17665-1:2006\nSterilization 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)\n169.\nEN ISO 18777:2009\nTransportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)\n170.\nEN ISO 18778:2009\nRespiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)\n171.\nEN ISO 18779:2005\nMedical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)\n172.\nEN ISO 19054:2006\nRail systems for supporting medical equipment (ISO 19054:2005)\n173.\nEN 20594-1:1993\nConical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)\nEN 20594-1:1993/A1:1997\nEN 20594-1:1993/AC:1996\n174.\nEN ISO 21534:2009\nNon-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)\n175.\nEN ISO 21535:2009\nNon-active surgical implants - Joint replacement implants - Specific requirements for hip- joint replacement implants (ISO 21535:2007)\n176.\nEN ISO 21536:2009\nNon-active surgical implants - Joint replacement implants - Specific requirements for knee- joint replacement implants (ISO 21536:2007)\n177.\nEN ISO 21649:2009\nNeedle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)\n178.\nEN ISO 21969:2009\nHigh-pressure flexible connections for use with medical gas systems (ISO 21969:2009)\n179.\nEN ISO 21987:2017\nOphthalmic optics - Mounted spectacle lenses (ISO 21987:2017)\n180.\nEN ISO 22442-1:2007\nMedical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007)\n181.\nEN ISO 22442-2:2007\nMedical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)\n182.\nEN ISO 22442-3:2007\nMedical 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)\n183.\nEN ISO 22523:2006\nExternal limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)\nNotice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant essential requirements of the amended directive are appropriately covered.\n184.\nEN ISO 22675:2016\nProsthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)\n185.\nEN ISO 23328-1:2008\nBreathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 23328- 1:2003)\n186.\nEN ISO 23328-2:2009\nBreathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)\n187.\nEN ISO 23747:2009\nAnaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)\n188.\nEN ISO 25424:2019\nSterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)\n189.\nEN ISO 25539-1:2009\nCardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)\nEN ISO 25539-1:2009/AC:2011\n190.\nEN ISO 25539-2:2009\nCardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539- 2:2008)\nEN ISO 25539-2:2009/AC:2011\n191.\nEN ISO 26782:2009\nAnaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)\nEN ISO 26782:2009/AC:2009\n192.\nEN 27740:1992\nInstruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)\nEN 27740:1992/A1:1997\nEN 27740:1992/AC:1996\n193.\nEN 60118-13:2005\nElectroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC) (IEC 60118-13:2004)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n194.\nEN 60522:1999\nDetermination of the permanent filtration of X- ray tube assemblies (IEC 60522:1999)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n195.\nEN 60580:2000\nMedical electrical equipment - Dose area product meters (IEC 60580:2000)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n196.\nEN 60601-1:2006\nMedical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)\nEN 60601-1:2006/AC:2010\nEN 60601-1:2006/A1:2013 (IEC 60601-1:2005/A1:2012)\n197.\nEN 60601-1-1:2001\nMedical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1:2000)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n198.\nEN 60601-1-2:2015\nMedical 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)\n199.\nEN 60601-1-3:2008\nMedical 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)\nEN 60601-1-3:2008/AC:2010\nEN 60601-1-3:2008/A11:2016\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n200.\nEN 60601-1-4:1996\nMedical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems (IEC 60601-1-4:1996)\nEN 60601-1-4:1996/A1:1999 (IEC 60601-1-4:1996/A1:1999)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n201.\nEN 60601-1-6:2010\nMedical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n202.\nEN 60601-1-8:2007\nMedical 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)\nEN 60601-1-8:2007/AC:2010\nEN 60601-1-8:2007/A11:2017\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n203.\nEN 60601-1-10:2008\nMedical 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)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n204.\nEN 60601-1-11:2010\nMedical 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)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n205.\nEN 60601-2-1:1998\nMedical 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)\nEN 60601-2-1:1998/A1:2002 (IEC 60601-2-1:1998/A1:2002)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n206.\nEN 60601-2-2:2009\nMedical 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)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n207.\nEN 60601-2-3:1993\nMedical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipment (IEC 60601-2-3:1991)\nEN 60601-2-3:1993/A1:1998 (IEC 60601-2-3:1991/A1:1998)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n208.\nEN 60601-2-4:2003\nMedical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators (IEC 60601-2-4:2002)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n209.\nEN 60601-2-5:2000\nMedical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment (IEC 60601-2-5:2000)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n210.\nEN 60601-2-8:1997\nMedical 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)\nEN 60601-2-8:1997/A1:1997 (IEC 60601-2-8:1987/A1:1997)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n211.\nEN 60601-2-10:2000\nMedical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators (IEC 60601-2-10:1987)\nEN 60601-2-10:2000/A1:2001 (IEC 60601-2-10:1987/A1:2001)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n212.\nEN 60601-2-11:1997\nMedical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment (IEC 60601-2-11:1997)\nEN 60601-2-11:1997/A1:2004 (IEC 60601-2-11:1997/A1:2004)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n213.\nEN 60601-2-12:2006\nMedical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators (IEC 60601-2-12:2001)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n214.\nEN 60601-2-13:2006\nMedical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems (IEC 60601-2-13:2003)\nEN 60601-2-13:2006/A1:2007 (IEC 60601-2-13:2003/A1:2006)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n215.\nEN 60601-2-16:1998\nMedical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:1998)\nEN 60601-2-16:1998/AC:1999\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n216.\nEN 60601-2-17:2004\nMedical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment (IEC 60601-2-17:2004)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n217.\nEN 60601-2-18:1996\nMedical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment (IEC 60601-2-18:1996)\nEN 60601-2-18:1996/A1:2000 (IEC 60601-2-18:1996/A1:2000)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n218.\nEN 60601-2-19:2009\nMedical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:2009)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n219.\nEN 60601-2-20:2009\nMedical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (IEC 60601-2-20:2009)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n220.\nEN 60601-2-21:2009\nMedical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (IEC 60601-2-21:2009)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n221.\nEN 60601-2-22:1996\nMedical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment (IEC 60601-2-22:1995)\nNotice: This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n222.\nEN 60601-2-23:2000\nMedical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment (IEC 60601-2-23:1999)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n223.\nEN 60601-2-24:1998\nMedical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers (IEC 60601-2-24:1998)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n224.\nEN 60601-2-25:1995\nMedical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs (IEC 60601-2-25:1993)\nEN 60601-2-25:1995/A1:1999 (IEC 60601-2-25:1993/A1:1999)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n225.\nEN 60601-2-26:2003\nMedical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs (IEC 60601-2-26:2002)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n226.\nEN 60601-2-27:2006\nMedical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment (IEC 60601-2-27:2005)\nEN 60601-2-27:2006/AC:2006\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n227.\nEN 60601-2-28:2010\nMedical 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)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n228.\nEN 60601-2-29:2008\nMedical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators (IEC 60601-2-29:2008)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n229.\nEN 60601-2-30:2000\nMedical 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)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n230.\nEN 60601-2-33:2010\nMedical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2010)\nEN 60601-2-33:2010/A1:2015 (IEC 60601-2-33:2010/A1:2013)\nEN 60601-2-33:2010/A2:2015 (IEC 60601-2-33:2010/A2:2015)\nEN 60601-2-33:2010/AC:2016-03\nEN 60601-2-33:2010/A12:2016\n231.\nEN 60601-2-34:2000\nMedical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment (IEC 60601-2-34:2000)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n232.\nEN 60601-2-36:1997\nMedical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:1997)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n233.\nEN 60601-2-37:2008\nMedical 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)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n234.\nEN 60601-2-39:2008\nMedical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2007)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n235.\nEN 60601-2-40:1998\nMedical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment (IEC 60601-2-40:1998)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n236.\nEN 60601-2-41:2009\nMedical 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)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n237.\nEN 60601-2-43:2010\nMedical 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)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n238.\nEN 60601-2-44:2009\nMedical 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)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n239.\nEN 60601-2-45:2001\nMedical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-45:2001)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n240.\nEN 60601-2-46:1998\nMedical electrical equipment - Part 2-46: Particular requirements for the safety of operating tables (IEC 60601-2-46:1998)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n241.\nEN 60601-2-47:2001\nMedical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems (IEC 60601-2-47:2001)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n242.\nEN 60601-2-49:2001\nMedical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment (IEC 60601-2-49:2001)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n243.\nEN 60601-2-50:2009\nMedical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment (IEC 60601-2-50:2009)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n244.\nEN 60601-2-51:2003\nMedical 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)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n245.\nEN 60601-2-52:2010\nMedical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)\nEN 60601-2-52:2010/AC:2011\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n246.\nEN 60601-2-54:2009\nMedical 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)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n247.\nEN 60627:2001\nDiagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids (IEC 60627:2001)\nEN 60627:2001/AC:2002\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n248.\nEN 60645-1:2001\nElectroacoustics - Audiological equipment - Part 1: Pure-tone audiometers (IEC 60645-1:2001)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n249.\nEN 60645-2:1997\nAudiometers - Part 2: Equipment for speech audiometry (IEC 60645-2:1993)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n250.\nEN 60645-3:2007\nElectroacoustics - Audiometric equipment - Part 3: Test signals of short duration (IEC 60645-3:2007)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n251.\nEN 60645-4:1995\nAudiometers - Part 4: Equipment for extended high-frequency audiometry (IEC 60645-4:1994)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n252.\nEN 61217:2012\nRadiotherapy equipment - Coordinates, movements and scales (IEC 61217:2011)\n253.\nEN 61676:2002\nMedical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology (IEC 61676:2002)\nEN 61676:2002/A1:2009 (IEC 61676:2002/A1:2008)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n254.\nEN 62083:2009\nMedical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems (IEC 62083:2009)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n255.\nEN 62220-1:2004\nMedical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency (IEC 62220-1:2003)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n256.\nEN 62220-1-2:2007\nMedical 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)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n257.\nEN 62220-1-3:2008\nMedical 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)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n258.\nEN 62304:2006\nMedical device software - Software life-cycle processes (IEC 62304:2006)\nEN 62304:2006/AC:2008\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n259.\nEN 62366:2008\nMedical devices - Application of usability engineering to medical devices (IEC 62366:2007)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n260.\nEN 80601-2-35:2009\nMedical 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)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n261.\nEN 80601-2-58:2009\nMedical 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)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n262.\nEN 80601-2-59:2009\nMedical 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)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n263.\nEN ISO 81060-1:2012\nNon-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)\n264.\nEN ISO 81060-2:2019\nNon-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2020/437/annex/I",
    "retrieved_at": "2026-11-01T15:12:20.503794+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}