ESO (1) Reference and title of the harmonised standard (and reference document) Reference of superseded standard Date of cessation of presumption of conformity of superseded standard Note 1

CEN EN 285:2006 Sterilization — Steam sterilizers — Large sterilizers EN 285:1996 30.11.2008

CEN EN 375:2001 Information supplied by the manufacturer with in vitro diagnostic reagents for professional use —

CEN EN 376:2002 Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing —

CEN EN 455-1:2000 Medical gloves for single use — Part 1: Requirements and testing for freedom from holes EN 455-1:1993 Date Expired (30.4.2001)

CEN EN 455-2:2000 Medical gloves for single use — Part 2: Requirements and testing for physical properties (including Technical Corrigendum 1:1996) EN 455-2:1995 Date Expired (30.4.2001)

CEN EN 455-3:1999 Medical gloves for single use — Part 3: Requirements and testing for biological evaluation —

CEN EN 550:1994 Sterilization of medical devices — Validation and routine control of ethylene oxide sterilization —

CEN EN 556-1:2001 Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices EN 556:1994 + A1:1998 Date Expired (30.4.2002)

EN 556-1:2001/AC:2006

CEN EN 556-2:2003 Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices —

CEN EN 591:2001 Instructions for use for in vitro diagnostic instruments for professional use —

CEN EN 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing —

CEN EN 737-1:1998 Medical gas pipeline systems — Part 1: Terminal units for compressed medical gases and vacuum —

CEN EN 737-2:1998 Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems — Basic requirements —

EN 737-2:1998/A1:1999 Note 3 Date Expired (30.6.2000)

CEN EN 737-3:1998 Medical gas pipeline systems — Part 3: Pipelines for compressed medical gases and vacuum —

EN 737-3:1998/A1:1999 Note 3 Date Expired (30.6.2000)

CEN EN 737-4:1998 Medical gas pipeline systems — Part 4: Terminal units for anaesthetic gas scavenging systems —

CEN EN 738-4:1998 Pressure regulators for use with medical gases — Part 4: Low-pressure regulators intended for incorporation into medical equipment —

EN 738-4:1998/A1:2002 Note 3 Date Expired (31.10.2002)

CEN EN 739:1998 Low-pressure hose assemblies for use with medical gases —

EN 739:1998/A1:2002 Note 3 Date Expired (31.10.2002)

CEN EN 740:1998 Anaesthetic workstations and their modules — Particular requirements —

EN 740:1998/A1:2004 Note 3 Date Expired (31.7.2004)

EN 740:1998/AC:1998

CEN EN 794-1:1997 Lung ventilators — Part 1: Particular requirements for critical care ventilators —

EN 794-1:1997/A1:2000 Note 3 Date Expired (31.5.2001)

CEN EN 794-3:1998 Lung ventilators — Part 3: Particular requirements for emergency and transport ventilators —

EN 794-3:1998/A1:2005 Note 3 Date Expired (31.12.2005)

CEN EN 867-3:1997 Non-biological systems for use in sterilizers — Part 3: Specification for Class B indicators for use in the Bowie and Dick test —

CEN EN 980:2003 Graphical symbols for use in the labelling of medical devices EN 980:1996 Date Expired (31.10.2003)

CEN EN 1041:1998 Information supplied by the manufacturer with medical devices —

CEN EN 1060-1:1995 Non-invasive sphygmomanometers — Part 1: General requirements —

EN 1060-1:1995/A1:2002 Note 3 Date Expired (30.11.2002)

CEN EN 1060-2:1995 Non-invasive sphygmomanometers — Part 2: Supplementary requirements for mechanical sphygmomanometers —

CEN EN 1060-3:1997 Non-invasive sphygmomanometers — Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems —

EN 1060-3:1997/A1:2005 Note 3 Date Expired (30.6.2006)

CEN EN 1060-4:2004 Non-invasive sphygmomanometers — Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers —

CEN EN 1089-3:2004 Transportable gas cylinders — Gas cylinder identification (excluding LPG) — Part 3: Colour coding EN 1089-3:1997 Date Expired (31.10.2004)

CEN EN 1280-1:1997 Agent specific filling systems for anaesthetic vaporizers — Part 1: Rectangular keyed filling systems —

EN 1280-1:1997/A1:2000 Note 3 Date Expired (24.11.2000)

CEN EN 1281-2:1995 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:1987 modified) —

CEN EN 1282-2:2005 Tracheostomy tubes — Part 2: Paediatric tubes (ISO 5366-3:2001, modified) EN 1282-2:1997 Date Expired (31.12.2005)

CEN EN 1422:1997 Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods —

CEN EN 1618:1997 Catheters other than intravascular catheters — Test methods for common properties —

CEN EN 1639:2004 Dentistry — Medical devices for dentistry — Instruments EN 1639:1996 Date Expired (31.12.2004)

CEN EN 1640:2004 Dentistry — Medical devices for dentistry — Equipment EN 1640:1996 Date Expired (31.12.2004)

CEN EN 1641:2004 Dentistry — Medical devices for dentistry — Materials EN 1641:1996 Date Expired (31.12.2004)

CEN EN 1642:2004 Dentistry — Medical devices for dentistry — Dental implants EN 1642:1996 Date Expired (31.12.2004)

CEN EN 1707:1996 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Lock fittings —

CEN EN 1782:1998 Tracheal tubes and connectors —

CEN EN 1789:1999 Medical vehicles and their equipment — Road ambulances —

EN 1789:1999/A1:2003 Note 3 Date Expired (30.9.2003)

CEN EN 1820:2005 Anaesthetic reservoir bags (ISO 5362:2000, modified) EN 1820:1997 Date Expired (31.12.2005)

CEN EN 1865:1999 Specifications for stretchers and other patient handling equipment used in road ambulances —

CEN EN 1970:2000 Adjustable beds for disabled persons — Requirements and test methods —

EN 1970:2000/A1:2005 Note 3 Date Expired (30.9.2005)

CEN EN 1985:1998 Walking aids — General requirements and test methods —

CEN EN ISO 4074:2002 Natural latex rubber condoms — Requirements and test methods (ISO 4074:2002) EN 600:1996 Date Expired (31.8.2005)

CEN EN ISO 4135:2001 Anaesthetic and respiratory equipment — Vocabulary (ISO 4135:2001) EN ISO 4135:1996 Date Expired (28.2.2002)

CEN EN ISO 5356-1:2004 Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets (ISO 5356-1:2004) EN 1281-1:1997 Date Expired (30.11.2004)

CEN EN ISO 5366-1:2004 Anaesthetic and respiratory equipment — Tracheostomy tubes — Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000) EN 1282-1:1996 Date Expired (31.1.2005)

CEN EN ISO 5840:2005 Cardiovascular implants — Cardiac valve prostheses (ISO 5840:2005) EN 12006-1:1999 Date Expired (30.6.2006)

CEN EN ISO 7197:2006 Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006) —

CEN EN ISO 7376:2003 Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation (ISO 7376:2003) EN 1819:1997 Date Expired (30.6.2004)

CEN EN ISO 7439:2002 Copper-bearing intra-uterine contraceptive devices — Requirements, tests (ISO 7439:2002) —

CEN EN ISO 7886-3:2005 Sterile hypodermic syringes for single use — Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005) —

CEN EN ISO 8185:1997 Humidifiers for medical use — General requirements for humidification systems (ISO 8185:1997) —

CEN EN ISO 8359:1996 Oxygen concentrators for medical use — Safety requirements (ISO 8359:1996) —

CEN EN ISO 8835-4:2004 Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004) —

EN ISO 8835-4:2004/AC:2006

CEN EN ISO 8835-5:2004 Inhalational anaesthesia systems — Part 5: Anaesthesia ventilators (ISO 8835-5:2004) —

EN ISO 8835-5:2004/AC:2006

CEN EN ISO 9360-1:2000 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000) —

CEN EN ISO 9360-2:2002 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001) —

CEN EN ISO 9713:2004 Neurosurgical implants — Self-closing intracranial aneurysm clips (ISO 9713:2002) —

CEN EN ISO 9919:2005 Medical electrical equipment — Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) EN 865:1997 Date Expired (30.9.2005)

CEN EN ISO 10079-1:1999 Medical suction equipment — Part 1: Electrically powered suction equipment — Safety requirements (ISO 10079-1:1999) EN ISO 10079-1:1996 Date Expired (29.2.2000)

CEN EN ISO 10079-2:1999 Medical suction equipment — Part 2: Manually powered suction equipment (ISO 10079-2:1999) EN ISO 10079-2:1996 Date Expired (29.2.2000)

CEN EN ISO 10079-3:1999 Medical suction equipment — Part 3: Suction equipment powered from vacuum or pressure source (ISO 10079-3:1999) EN ISO 10079-3:1996 Date Expired (29.2.2000)

CEN EN ISO 10524-1:2006 Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) EN 738-1:1997 31.10.2008

CEN EN ISO 10524-2:2006 Pressure regulators for use with medical gases — Part 2: Manifold and line pressure regulators (ISO 10524-2:2005) EN 738-2:1998 31.10.2008

CEN EN ISO 10524-3:2006 Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005) EN 738-3:1998 31.10.2008

CEN EN ISO 10535:1998 Hoists for the transfer of disabled persons — Requirements and test methods (ISO 10535:1998) —

CEN EN ISO 10555-1:1996 Sterile, single-use intravascular catheters — Part 1: General requirements (ISO 10555-1:1995) —

EN ISO 10555-1:1996/A1:1999 Note 3 Date Expired (31.1.2000)

EN ISO 10555-1:1996/A2:2004 Note 3 Date Expired (30.11.2004)

CEN EN ISO 10651-2:2004 Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004) EN 794-2:1997 Date Expired (31.1.2005)

CEN EN ISO 10651-4:2002 Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) —

CEN EN ISO 10651-6:2004 Lung 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 10993-1:2003 Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003) —

CEN EN ISO 10993-3:2003 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003) EN 30993-3:1993 Date Expired (30.4.2004)

CEN EN ISO 10993-4:2002 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002) EN 30993-4:1993 Date Expired (30.4.2003)

EN ISO 10993-4:2002/A1:2006 Note 3 31.1.2007

CEN EN ISO 10993-5:1999 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999) EN 30993-5:1994 Date Expired (30.11.1999)

CEN EN ISO 10993-9:1999 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999) —

CEN EN ISO 10993-10:2002 Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002) EN ISO 10993-10:1995 Date Expired (31.3.2003)

EN ISO 10993-10:2002/A1:2006 Note 3 31.1.2007

CEN EN ISO 10993-11:2006 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006) EN ISO 10993-11:1995 28.2.2007

CEN EN ISO 10993-12:2004 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2002) EN ISO 10993-12:1996 Date Expired (31.5.2005)

CEN EN ISO 10993-13:1998 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) —

CEN EN ISO 10993-14:2001 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) —

CEN EN ISO 10993-15:2000 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) —

CEN EN ISO 10993-16:1997 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997) —

CEN EN ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) —

CEN EN ISO 10993-18:2005 Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005) —

CEN EN ISO 11137-1:2006 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006) EN 552:1994 30.4.2009

CEN EN ISO 11137-2:2006 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2006) EN 552:1994 30.4.2009

CEN EN ISO 11138-2:2006 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) —

CEN EN ISO 11138-3:2006 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) —

CEN EN ISO 11140-1:2005 Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005) EN 867-2:1997 Date Expired (31.1.2006)

CEN EN ISO 11197:2004 Medical supply units (ISO 11197:2004) EN 793:1997 Date Expired (30.6.2005)

CEN EN ISO 11607-1:2006 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) EN 868-1:1997 Date Expired (30.4.2006)

CEN EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) —

CEN EN ISO 11737-1:2006 Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) EN 1174-1:1996 EN 1174-2:1996 EN 1174-3:1996 31.10.2006

CEN EN ISO 11979-8:2006 Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements (ISO 11979-8:2006) EN 13503-8:2000 31.1.2007

CEN EN ISO 11990:2003 Optics and optical instruments — Lasers and laser-related equipment — Determination of laser resistance of tracheal tube shafts (ISO 11990:2003) EN ISO 11990:1999 Date Expired (31.10.2003)

CEN EN 12006-2:1998 Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 2: Vascular prostheses including cardiac valve conduits —

CEN EN 12006-3:1998 Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 3: Endovascular devices —

CEN EN 12010:1998 Non-active surgical implants — Joint replacement implants — Particular requirements —

CEN EN 12011:1998 Instrumentation to be used in association with non-active surgical implants — General requirements —

CEN EN 12182:1999 Technical aids for disabled persons — General requirements and test methods —

CEN EN 12183:2006 Manual wheelchairs — Requirements and test methods EN 12183:1999 31.3.2007

CEN EN 12184:2006 Electrically powered wheelchairs, scooters and their chargers — Requirements and test methods EN 12184:1999 31.3.2007

CEN EN 12322:1999 In vitro diagnostic medical devices — Culture media for microbiology — Performance criteria for culture media —

EN 12322:1999/A1:2001 Note 3 Date Expired (30.4.2002)

CEN EN 12342:1998 Breathing tubes intended for use with anaesthetic apparatus and ventilators —

CEN EN 12442-1:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices — Part 1: Analysis and management of risk —

CEN EN 12442-2:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices — Part 2: Controls on sourcing, collection and handling —

CEN EN 12442-3:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents —

CEN EN 12470-1:2000 Clinical thermometers — Part 1: Metallic liquid-in-glass thermometers with maximum device —

CEN EN 12470-2:2000 Clinical thermometers — Part 2: Phase change type (dot matrix) thermometers —

CEN EN 12470-3:2000 Clinical thermometers — Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device —

CEN EN 12470-4:2000 Clinical thermometers — Part 4: Performance of electrical thermometers for continuous measurement —

CEN EN 12470-5:2003 Clinical thermometers — Part 5: Performance of infra-red ear thermometers (with maximum device) —

CEN EN 12523:1999 External limb prostheses and external orthoses — Requirements and test methods —

CEN EN 12563:1998 Non-active surgical implants — Joint replacement implants — Specific requirements for hip joint replacement implants —

CEN EN 12564:1998 Non-active surgical implants — Joint replacement implants — Specific requirements for knee joint replacement implants —

CEN EN ISO 12870:2004 Ophthalmic optics — Spectacle frames — Requirements and test methods (ISO 12870:2004) EN ISO 12870:1997 Date Expired (28.2.2005)

EN ISO 12870:2004/AC:2005

CEN EN 13014:2000 Connections for gas sampling tubes to anaesthetic and respiratory equipment —

CEN EN 13060:2004 Small steam sterilizers —

CEN EN 13220:1998 Flow-metering devices for connection to terminal units of medical gas pipeline systems —

CEN EN 13328-1:2001 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance —

CEN EN 13328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects —

EN 13328-2:2002/A1:2003 Note 3 Date Expired (30.6.2004)

CEN EN ISO 13485:2003 Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) EN ISO 13485:2000 EN ISO 13488:2000 Date Expired (31.7.2006)

CEN EN 13544-1:2001 Respiratory therapy equipment — Part 1: Nebulizing systems and their components —

EN 13544-1:2001/A1:2004 Note 3 Date Expired (31.12.2004)

CEN EN 13544-2:2002 Respiratory therapy equipment — Part 2: Tubing and connectors —

CEN EN 13544-3:2001 Respiratory therapy equipment — Part 3: Air entrainment devices —

CEN EN 13624:2003 Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area — Test method and requirements (phase 2, step 1) —

CEN EN 13718-1:2002 Air, water and difficult terrain ambulances — Part 1: Medical device interface requirements for the continuity of patient care —

CEN EN 13718-2:2002 Air, water and difficult terrain ambulances — Part 2: Operational and technical requirements for the continuity of patient care —

CEN EN 13726-1:2002 Test methods for primary wound dressings — Part 1: Aspects of absorbency —

CEN EN 13726-2:2002 Test methods for primary wound dressings — Part 2: Moisture vapour transmission rate of permeable film dressings —

CEN EN 13727:2003 Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area — Test method and requirements (phase 2, step 1) —

CEN EN 13795-1:2002 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Part 1: General requirements for manufacturers, processors and products —

CEN EN 13795-2:2004 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 2: Test methods —

CEN EN 13795-3:2006 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 3: Performance requirements and performance levels —

CEN EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements —

CEN EN 13826:2003 Peak expiratory flow meters —

CEN EN 13867:2002 Concentrates for haemodialysis and related therapies —

CEN EN 13976-1:2003 Rescue systems — Transportation of incubators — Part 1: Interface conditions —

CEN EN 13976-2:2003 Rescue systems — Transportation of incubators — Part 2: System requirements —

CEN EN 14079:2003 Non-active medical devices — Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze —

CEN EN ISO 14155-1:2003 Clinical investigation of medical devices for human subjects — Part 1: General requirements (ISO 14155-1:2003) EN 540:1993 Date Expired (31.8.2003)

CEN EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003) —

CEN EN ISO 14160:1998 Sterilization of single-use medical devices incorporating materials of animal origin — Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998) —

CEN EN 14180:2003 Sterilizers for medical purposes — Low temperature steam and formaldehyde sterilizers — Requirements and testing —

CEN EN 14299:2004 Non active surgical implants — Particular requirements for cardiac and vascular implants — Specific requirements for arterial stents —

CEN EN 14348:2005 Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants — Test methods and requirements (phase 2, step 1) —

CEN EN ISO 14408:2005 Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information (ISO 14408:2005) —

CEN EN ISO 14534:2002 Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements (ISO 14534:2002) EN ISO 14534:1997 Date Expired (31.12.2002)

CEN EN 14561:2006 Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area — Test method and requirements (phase 2, step 2) —

CEN EN 14562:2006 Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area — Test method and requirements (phase 2, step 2) —

CEN EN ISO 14602:1998 Non-active surgical implants — Implants for Osteosynthesis — Particular requirements (ISO 14602:1998) —

CEN EN ISO 14630:2005 Non-active surgical implants — General requirements (ISO 14630:2005) EN ISO 14630:1997 Date Expired (30.11.2005)

CEN EN 14683:2005 Surgical masks — Requirements and test methods —

CEN EN ISO 14889:2003 Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses (ISO 14889:2003) EN ISO 14889:1997 Date Expired (30.11.2003)

CEN EN 14931:2006 Pressure vessels for human occupancy (PVHO) — Multi-place pressure chamber systems for hyperbaric therapy — Performance, safety requirements and testing —

CEN EN ISO 14937:2000 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000) —

CEN EN ISO 14971:2000 Medical devices — Application of risk management to medical devices (ISO 14971:2000) EN 1441:1997 Date Expired (31.3.2004)

EN ISO 14971:2000/A1:2003 Note 3 Date Expired (31.3.2004)

CEN EN ISO 15001:2004 Anaesthetic and respiratory equipment — Compatibility with oxygen (ISO 15001:2003) —

CEN EN ISO 15004-1:2006 Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006) EN ISO 15004:1997 31.12.2006

CEN EN ISO 15225:2000 Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000) —

EN ISO 15225:2000/A1:2004 Note 3 Date Expired (31.8.2004)

CEN EN ISO 15747:2005 Plastics containers for intravenous injection (ISO 15747:2003) —

CEN EN ISO 15883-1:2006 Washer-disinfectors — Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) —

CEN EN ISO 15883-2:2006 Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006) —

CEN EN ISO 15883-3:2006 Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006) —

CEN EN ISO 17510-1:2002 Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy devices (ISO 17510-1:2002) —

CEN EN ISO 17510-2:2003 Sleep apnoea breathing therapy — Part 2: Masks and application accessories (ISO 17510-2:2003) —

CEN EN ISO 17664:2004 Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004) —

CEN EN ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) EN 554:1994 31.8.2009

CEN EN ISO 18777:2005 Transportable liquid oxygen systems for medical use — Particular requirements (ISO 18777:2005) —

CEN EN ISO 18778:2005 Respiratory equipment — Infant monitors — Particular requirements (ISO 18778:2005) —

CEN EN ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures — Particular requirements (ISO 18779:2005) —

CEN EN ISO 19054:2006 Rail systems for supporting medical equipment (ISO 19054:2005) EN 12218:1998 30.6.2008

CEN EN 20594-1:1993 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements (ISO 594-1:1986) —

EN 20594-1:1993/A1:1997 Note 3 Date Expired (31.5.1998)

CEN EN ISO 21171:2006 Medical gloves — Determination of removable surface powder (ISO 21171:2006) —

CEN EN ISO 21647:2004 Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004) EN 12598:1999 EN 864:1996 EN ISO 11196:1997 Date Expired (31.5.2005)

EN ISO 21647:2004/AC:2006

CEN EN ISO 21649:2006 Needle-free injectors for medical use — Requirements and test methods (ISO 21649:2006) —

CEN EN ISO 21969:2006 High-pressure flexible connections for use with medical gas systems (ISO 21969:2005) EN 13221:2000 31.12.2007

CEN EN ISO 22610:2006 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006) —

CEN EN ISO 22612:2005 Clothing for protection against infectious agents — Test method for resistance to dry microbial penetration (ISO 22612:2005) —

CEN EN 27740:1992 Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) —

EN 27740:1992/A1:1997 Note 3 Date Expired (31.5.1998)

CEN EN 30993-6:1994 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:1994) —