# Official Journal C 216/7 Se

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 216 |
| | |
| English edition | Information and Notices | Volume 497 September 2006 |

ISSN 1725-2423

Official Journal

of the European Union

C 216

English edition

Information and Notices

Volume 497 September 2006

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| Notice No | Contents | page |
| --- | --- | --- |
| | I   Information |
| | Commission |
| 2006/C 216/1 | Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(Publication of titles and references of harmonised standards under the directive)
   (
  1
  ) | 1 |
| 2006/C 216/2 | Commission communication in the framework of the implementation of the Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices(Publication of titles and references of harmonised standards under the directive)
   (
  1
  ) | 17 |
| 2006/C 216/3 | Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices(Publication of titles and references of harmonised standards under the directive)
   (
  1
  ) | 21 |

Notice No

Contents

page

I   Information

Commission

2006/C 216/1

Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(Publication of titles and references of harmonised standards under the directive)
   (
  1
  )

(Publication of titles and references of harmonised standards under the directive)

1

1

2006/C 216/2

Commission communication in the framework of the implementation of the Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices(Publication of titles and references of harmonised standards under the directive)
   (
  1
  )

(Publication of titles and references of harmonised standards under the directive)

1

17

2006/C 216/3

Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices(Publication of titles and references of harmonised standards under the directive)
   (
  1
  )

(Publication of titles and references of harmonised standards under the directive)

1

21

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| --- | --- |
| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

| EN | |
| --- | --- |

EN

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I Information

Commission

| 7.9.2006 | EN | Official Journal of the European Union | C 216/1 |
| --- | --- | --- | --- |

7.9.2006

EN

Official Journal of the European Union

C 216/1

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Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

(2006/C 216/01)

(Text with EEA relevance)

(Publication of titles and references of harmonised standards under the directive)

| 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
  Sterilisation — Steam sterilisers — Large sterilisers | 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
  Sterilisation of medical devices — Validation and routine control of ethylene oxide sterilisation | — | |
| CEN | EN 554:1994
  Sterilisation of medical devices — Validation and routine control of sterilisation by moist heat | — | |
| CEN | EN 556-1:2001
  Sterilisation of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilised medical devices | EN 556:1994 + A1:1998 | Date expired
  (30.4.2002) |
| CEN | EN 556-2:2003
  Sterilisation 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 sterilisers — 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
  Sterilisers for medical purposes — Ethylene oxide sterilisers — 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 | 31.8.2006 |
| 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 | 31.10.2006 |
| 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 | 31.10.2006 |
| 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) |
| 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 10993-7:1995
  Biological evaluation of medical devices — Part 7: Ethylene oxide sterilisation residuals (ISO 10993-7:1995) | — | |
| 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) |
| CEN | EN ISO 10993-11:1995
  Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:1993) | — | |
| 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
  Sterilisation of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 11137-1:2006) | EN 552:1994 | 30.4.2009 |
| CEN | EN ISO 11137-2:2006
  Sterilisation of health care products — Radiation — Part 2: Establishing the sterilisation dose (ISO 11137-2:2006) | EN 552:1994 | 30.4.2009 |
| CEN | EN ISO 11140-1:2005
  Sterilisation 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 sterilised 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 sterilised medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) | — | |
| CEN | EN ISO 11737-1:2006
  Sterilisation 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 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 12183:1999
  Manually propelled wheelchairs — Requirements and test methods | — | |
| CEN | EN 12184:1999
  Electrically powered wheelchairs, scooters and their charges — Requirements and test methods | — | |
| 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 sterilisers | — | |
| 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 13488:2000
  EN ISO 13485:2000 | 31.7.2006 |
| CEN | EN 13503-8:2000
  Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements (ISO 11979-8:1999, modified) | — | |
| 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
  Sterilisation 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
  Sterilisation of single-use medical devices incorporating materials of animal origin — Validation and routine control of sterilisation by liquid chemical sterilants (ISO 14160:1998) | — | |
| CEN | EN 14180:2003
  Sterilisers for medical purposes — Low temperature steam and formaldehyde sterilisers — 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
  Sterilisation of health care products — General requirements for characterization of a sterilising agent and the development, validation and routine control of a sterilisation 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
  Sterilisation of medical devices — Information to be provided by the manufacturer for the processing of resterilisable medical devices (ISO 17664:2004) | — | |
| 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 ISO 11196:1997
  EN 12598:1999
  EN 864:1996 | 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 | 31.12.2006 |
| 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) | — | |
| CEN | EN 46003:1999
  Quality systems — Medical devices — Particular requirements for the application of EN ISO 9003 | — | |

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

Sterilisation — Steam sterilisers — Large sterilisers

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

Sterilisation of medical devices — Validation and routine control of ethylene oxide sterilisation

—

CEN

EN 554:1994

Sterilisation of medical devices — Validation and routine control of sterilisation by moist heat

—

CEN

EN 556-1:2001

Sterilisation of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilised medical devices

EN 556:1994 + A1:1998

Date expired

(30.4.2002)

CEN

EN 556-2:2003

Sterilisation 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 sterilisers — 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

Sterilisers for medical purposes — Ethylene oxide sterilisers — 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

31.8.2006

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

31.10.2006

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

31.10.2006

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)

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 10993-7:1995

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilisation residuals (ISO 10993-7:1995)

—

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)

CEN

EN ISO 10993-11:1995

Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:1993)

—

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

Sterilisation of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 11137-1:2006)

EN 552:1994

30.4.2009

CEN

EN ISO 11137-2:2006

Sterilisation of health care products — Radiation — Part 2: Establishing the sterilisation dose (ISO 11137-2:2006)

EN 552:1994

30.4.2009

CEN

EN ISO 11140-1:2005

Sterilisation 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 sterilised 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 sterilised medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)

—

CEN

EN ISO 11737-1:2006

Sterilisation 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 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 12183:1999

Manually propelled wheelchairs — Requirements and test methods

—

CEN

EN 12184:1999

Electrically powered wheelchairs, scooters and their charges — Requirements and test methods

—

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 sterilisers

—

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 13488:2000

EN ISO 13485:2000

31.7.2006

CEN

EN 13503-8:2000

Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements (ISO 11979-8:1999, modified)

—

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

Sterilisation 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

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

—

CEN

EN 14180:2003

Sterilisers for medical purposes — Low temperature steam and formaldehyde sterilisers — 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

Sterilisation of health care products — General requirements for characterization of a sterilising agent and the development, validation and routine control of a sterilisation 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

Sterilisation of medical devices — Information to be provided by the manufacturer for the processing of resterilisable medical devices (ISO 17664:2004)

—

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 ISO 11196:1997

EN 12598:1999

EN 864:1996

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

31.12.2006

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)

—

CEN

EN 46003:1999

Quality systems — Medical devices — Particular requirements for the application of EN ISO 9003

—

| Note 1 | Generally the date of cessation of presumption of conformity will be the date of withdrawal (dow), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
| --- | --- |
| Note 3 | In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive. |

Note 1

Generally the date of cessation of presumption of conformity will be the date of withdrawal (dow), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

Note 3

In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

Note:

| — | Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council (2) amended by the Directive 98/48/EC (3). |
| --- | --- |

—

Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council (2) amended by the Directive 98/48/EC (3).

| — | Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the Community languages. |
| --- | --- |

—

Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the Community languages.

| — | This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list. |
| --- | --- |

—

This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list.

More information about harmonised standards on the Internet at

http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/

---

(1)  ESO: European Standardisation Organisation:

| — | CEN: rue de Stassart 36, B-1050 Brussels, Tel.(32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cenorm.be) |
| --- | --- |

—

CEN: rue de Stassart 36, B-1050 Brussels, Tel.(32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cenorm.be)

| — | CENELEC: rue de Stassart 35, B-1050 Brussels, Tel.(32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org) |
| --- | --- |

—

CENELEC: rue de Stassart 35, B-1050 Brussels, Tel.(32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org)

| — | ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel.(33) 492 94 42 00; fax (33) 493 65 47 16 (http://www.etsi.org) |
| --- | --- |

—

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel.(33) 492 94 42 00; fax (33) 493 65 47 16 (http://www.etsi.org)

(2)  OJ L 204, 21.7.1998, p. 37.

(3)  OJ L 217, 5.8.1998, p. 18.

---

| 7.9.2006 | EN | Official Journal of the European Union | C 216/17 |
| --- | --- | --- | --- |

7.9.2006

EN

Official Journal of the European Union

C 216/17

---

Commission communication in the framework of the implementation of the Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices

(2006/C 216/02)

(Text with EEA relevance)

(Publication of titles and references of harmonised standards under the directive)

| 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 550:1994
  Sterilisation of medical devices — Validation and routine control of ethylene oxide sterilisation | — | |
| CEN | EN 554:1994
  Sterilisation of medical devices — Validation and routine control of sterilization by moist heat | — | |
| CEN | EN 556-1:2001
  Sterilisation of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilised medical devices | EN 556:1994 + A1:1998 | Date expired
  (30.4.2002) |
| CEN | EN 556-2:2003
  Sterilisation of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices | — | |
| 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 ISO 10993-1:2003
  Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003) | — | |
| 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) |
| 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) |
| CEN | EN ISO 10993-11:1995
  Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:1993) | — | |
| 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 10993-16:1997
  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 characterisation of materials (ISO 10993-18:2005) | — | |
| CEN | EN ISO 11137-1:2006
  Sterilization of healthcare products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 11137-1:2006) | EN 552:1994 | 30.4.2009 |
| CEN | EN ISO 11137-2:2006
  Sterilisation of healthcare products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2006) | EN 552:1994 | 30.4.2009 |
| CEN | EN ISO 11140-1:2005
  Sterilization of healthcare products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005) | — | |
| CEN | EN ISO 11607-1:2006
  Packaging for terminally sterilised 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 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 13485:2003
  Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) | EN ISO 13485:2000
  EN ISO 13488:2000 | 31.7.2006 |
| CEN | EN 13824:2004
  Sterilisation of medical devices — Aseptic processing of liquid medical devices — Requirements | — | |
| 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 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 30993-6:1994
  Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:1994) | — | |
| CEN | EN 45502-1:1997
  Active implantable medical devices — Part 1: General requirements for safety, marking and information to be provided by the manufacturer | — | |
| CEN | EN 45502-2-1:2004
  Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) | — | |

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 550:1994

Sterilisation of medical devices — Validation and routine control of ethylene oxide sterilisation

—

CEN

EN 554:1994

Sterilisation of medical devices — Validation and routine control of sterilization by moist heat

—

CEN

EN 556-1:2001

Sterilisation of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilised medical devices

EN 556:1994 + A1:1998

Date expired

(30.4.2002)

CEN

EN 556-2:2003

Sterilisation of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices

—

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 ISO 10993-1:2003

Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003)

—

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)

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)

CEN

EN ISO 10993-11:1995

Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:1993)

—

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 10993-16:1997

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 characterisation of materials (ISO 10993-18:2005)

—

CEN

EN ISO 11137-1:2006

Sterilization of healthcare products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 11137-1:2006)

EN 552:1994

30.4.2009

CEN

EN ISO 11137-2:2006

Sterilisation of healthcare products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2006)

EN 552:1994

30.4.2009

CEN

EN ISO 11140-1:2005

Sterilization of healthcare products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005)

—

CEN

EN ISO 11607-1:2006

Packaging for terminally sterilised 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 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 13485:2003

Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)

EN ISO 13485:2000

EN ISO 13488:2000

31.7.2006

CEN

EN 13824:2004

Sterilisation of medical devices — Aseptic processing of liquid medical devices — Requirements

—

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 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 30993-6:1994

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

—

CEN

EN 45502-1:1997

Active implantable medical devices — Part 1: General requirements for safety, marking and information to be provided by the manufacturer

—

CEN

EN 45502-2-1:2004

Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

—

| Note 1 | Generally the date of cessation of presumption of conformity will be the date of withdrawal (dow), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
| --- | --- |
| Note 3 | In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive. |

Note 1

Generally the date of cessation of presumption of conformity will be the date of withdrawal (dow), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

Note 3

In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

Note:

| — | Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council (2) amended by the Directive 98/48/EC (3). |
| --- | --- |

—

Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council (2) amended by the Directive 98/48/EC (3).

| — | Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the Community languages. |
| --- | --- |

—

Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the Community languages.

| — | This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list. |
| --- | --- |

—

This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list.

More information about harmonised standards on the Internet at

http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/

---

(1)  ESO: European Standardisation Organisation:

| — | CEN: rue de Stassart 36, B-1050 Brussels, Tel.: (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cenorm.be) |
| --- | --- |

—

CEN: rue de Stassart 36, B-1050 Brussels, Tel.: (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cenorm.be)

| — | CENELEC: rue de Stassart 35, B-1050 Brussels, Tel.: (32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org) |
| --- | --- |

—

CENELEC: rue de Stassart 35, B-1050 Brussels, Tel.: (32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org)

| — | ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. (33) 492 94 42 00; fax: (33) 493 65 47 16 (http://www.etsi.org) |
| --- | --- |

—

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. (33) 492 94 42 00; fax: (33) 493 65 47 16 (http://www.etsi.org)

(2)  OJ L 204, 21.7.1998, p. 37.

(3)  OJ L 217, 5.8.1998, p. 18.

---

| 7.9.2006 | EN | Official Journal of the European Union | C 216/21 |
| --- | --- | --- | --- |

7.9.2006

EN

Official Journal of the European Union

C 216/21

---

Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

(2006/C 216/03)

(Text with EEA relevance)

(Publication of titles and references of harmonised standards under the directive)

| 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 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 556-1:2001
  Sterilisation of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilised medical devices | EN 556:1994 + A1:1998 | Date expired
  (30.4.2002) |
| 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 980:2003
  Graphical symbols for use in the labelling of medical devices | EN 980:1996 | Date expired
  (31.10.2003) |
| CEN | EN 12286:1998
  In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Presentation of reference measurement procedures | — | |
| | EN 12286:1998/A1:2000 | Note 3 | Date expired
  (24.11.2000) |
| CEN | EN 12287:1999
  In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials | — | |
| 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 ISO 13485:2003
  Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) | EN ISO 13488:2000
  EN ISO 13485:2000 | 31.7.2006 |
| CEN | EN 13532:2002
  General requirements for in vitro diagnostic medical devices for self-testing | — | |
| CEN | EN 13612:2002
  Performance evaluation of in vitro diagnostic medical devices | — | |
| CEN | EN 13640:2002
  Stability testing of in vitro diagnostic reagents | — | |
| CEN | EN 13641:2002
  Elimination or reduction of risk of infection related to in vitro diagnostic reagents | — | |
| CEN | EN 13975:2003
  Sampling procedures used for acceptance testing of in vitro diagnostic medical devices — Statistical aspects | — | |
| CEN | EN 14254:2004
  In vitro diagnostic medical devices — Single-use receptacles for the collection of specimens, other than blood, from humans | — | |
| CEN | EN 14820:2004
  Single-use containers for human venous blood specimen collection | — | |
| CEN | EN ISO 14937:2000
  Sterilisation of health care products — General requirements for characterisation of a sterilising agent and the development, validation and routine control of a sterilisation 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 ISO 14971:2000/A1:2003 | Note 3 | Date expired
  (31.3.2004) |
| CEN | EN ISO 15197:2003
  In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003) | — | |
| CEN | EN ISO 15225:2000
  Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000) | — | |
| CEN | EN ISO 17511:2003
  In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) | — | |
| CEN | EN ISO 18153:2003
  In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003) | — | |

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 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 556-1:2001

Sterilisation of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilised medical devices

EN 556:1994 + A1:1998

Date expired

(30.4.2002)

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 980:2003

Graphical symbols for use in the labelling of medical devices

EN 980:1996

Date expired

(31.10.2003)

CEN

EN 12286:1998

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Presentation of reference measurement procedures

—

EN 12286:1998/A1:2000

Note 3

Date expired

(24.11.2000)

CEN

EN 12287:1999

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials

—

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 ISO 13485:2003

Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)

EN ISO 13488:2000

EN ISO 13485:2000

31.7.2006

CEN

EN 13532:2002

General requirements for in vitro diagnostic medical devices for self-testing

—

CEN

EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices

—

CEN

EN 13640:2002

Stability testing of in vitro diagnostic reagents

—

CEN

EN 13641:2002

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

—

CEN

EN 13975:2003

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices — Statistical aspects

—

CEN

EN 14254:2004

In vitro diagnostic medical devices — Single-use receptacles for the collection of specimens, other than blood, from humans

—

CEN

EN 14820:2004

Single-use containers for human venous blood specimen collection

—

CEN

EN ISO 14937:2000

Sterilisation of health care products — General requirements for characterisation of a sterilising agent and the development, validation and routine control of a sterilisation 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 ISO 14971:2000/A1:2003

Note 3

Date expired

(31.3.2004)

CEN

EN ISO 15197:2003

In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)

—

CEN

EN ISO 15225:2000

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

—

CEN

EN ISO 17511:2003

In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)

—

CEN

EN ISO 18153:2003

In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)

—

| Note 1 | Generally the date of cessation of presumption of conformity will be the date of withdrawal (dow), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
| --- | --- |
| Note 3 | In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive. |

Note 1

Generally the date of cessation of presumption of conformity will be the date of withdrawal (dow), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

Note 3

In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

Note:

| — | Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council (2) amended by the Directive 98/48/EC (3). |
| --- | --- |

—

Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council (2) amended by the Directive 98/48/EC (3).

| — | Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the Community languages. |
| --- | --- |

—

Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the Community languages.

| — | This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list. |
| --- | --- |

—

This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list.

More information about harmonised standards on the Internet at

http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/

---

(1)  ESO: European Standardisation Organisation:

| — | CEN: rue de Stassart 36, B-1050 Brussels, Tel. (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cenorm.be) |
| --- | --- |

—

CEN: rue de Stassart 36, B-1050 Brussels, Tel. (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cenorm.be)

| — | CENELEC: rue de Stassart 35, B-1050 Brussels, Tel. (32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org) |
| --- | --- |

—

CENELEC: rue de Stassart 35, B-1050 Brussels, Tel. (32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org)

| — | ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel.(33) 492 94 42 00; fax (33) 493 65 47 16 (http://www.etsi.org) |
| --- | --- |

—

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel.(33) 492 94 42 00; fax (33) 493 65 47 16 (http://www.etsi.org)

(2)  OJ L 204, 21.7.1998, p. 37.

(3)  OJ L 217, 5.8.1998, p. 18.

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