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Medical devices

Directive 93/42/EEC concerning medical devices

Short name:	Medical devices
Base:	Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ No L 169/1 of 1993-07-12)
Modification:	[-]
Directive repealed as from 1.1.1995:	76/764/EEC
Application Guide:	Guidelines relating to the demarcation between Directives 90/385/EEC, 93/42/EEC and 65/65/EEC Guidelines on a Medical Devices Vigilance System
EC contact point:	DG Enterprise & Industry Mr. M. Kohler Tel. +32 2 296 75 83, Fax. +32 2 296.70.13 e-mail: e ntr-cosm-med-dev@ec.europa.eu Website on Active Implantable Medical Devices

Publications in the Official Journal:

Commission communication in relation to Council Directive 90/385/EEC on medical devices
OJ C 304 of 2008-11-27 (p 8-16)

(This publication concerns a list of references of harmonised standards related to medical devices in the electrotechnical field.
This 'consolidated' list published in OJ C 304 incorporates European standards adopted by CENELEC only. This list replaces the previous lists of CENELEC standards published in the Official Journal of the European Union.)
Commission communication in relation to Council Directive 93/42/EEC on medical devices
OJ C 186 of 2008-07-23 (p. 9-24)

(This publication concerns a list of references of harmonised standards related to medical devices in the general field.
This 'consolidated' list published in OJ C 186 incorporates European standards adopted by CEN only. This list replaces the previous lists of CEN standards published in the Official Journal of the European Union.)
Earlier publications: view

Summary list of titles and references of harmonised standards related to medical devices

The information contained in the summary list is a compilation of the references of standards which have been published in the Official Journal of the European Union.
Although the lists are updated regularly, they may not be complete and they do not have any legal validity; only publication in the Official Journal produces legal affect.

The following summary list of references of harmonised standards is split into two tables. The first part of the table includes the references of the harmonised standards from EN 375:2001 to EN 27740:1992/A1:1997. The second part of the table starts with the references of harmonised standard EN 60118-13:2005.

First part of summary table (includes the references of the harmonised standards from EN 375:2001 to EN 27740:1992/A1:1997)
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 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes	EN 455-1:1993	Date expired (30.04.2001)
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 (30.04.2001)
CEN	EN 455-3:2006 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation	EN 455-3:1999	Date expired (30.06.2007)
CEN	EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices	EN 556:1994 + A1:1998	Date expired (30.04.2002)
	EN 556-1:2001/AC:2006
CEN	EN 556-2:2003 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices	—
CEN	EN 591:2001 Instructions for use for in vitro diagnostic instruments for professional use	—
CEN	EN 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing	—
CEN	EN 737-1:1998 Medical gas pipeline systems - Part 1: Terminal units for compressed medical gases and vacuum	—
CEN	EN 737-4:1998 Medical gas pipeline systems - Part 4: Terminal units for anaesthetic gas scavenging systems	—
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 (31.05.2001)
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 980:2008 Symbols for use in the labelling of medical devices	EN 980:2003	31.05.2010
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 (30.06.2006)
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 1282-2:2005 Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)	EN 1282-2:1997	Date expired (31.12.2005)
CEN	EN 1422:1997 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods	—
CEN	EN 1618:1997 Catheters other than intravascular catheters - Test methods for common properties	—
CEN	EN 1639:2004 Dentistry - Medical devices for dentistry - Instruments	EN 1639:1996	Date expired (31.12.2004)
CEN	EN 1640:2004 Dentistry - Medical devices for dentistry - Equipment	EN 1640:1996	Date expired (31.12.2004)
CEN	EN 1641:2004 Dentistry - Medical devices for dentistry - Materials	EN 1641:1996	Date expired (31.12.2004)
CEN	EN 1642:2004 Dentistry - Medical devices for dentistry - Dental implants	EN 1642:1996	Date expired (31.12.2004)
CEN	EN 1707:1996 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings	—
CEN	EN 1782:1998 Tracheal tubes and connectors	—
CEN	EN 1789:2007 Medical vehicles and their equipment - Road ambulances	EN 1789:1999	Date expired (30.11.2007)
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 (30.09.2005)
CEN	EN 1985:1998 Walking aids - General requirements and test methods	—
CEN	EN ISO 3826-3:2007 Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)	—
CEN	EN ISO 4074:2002 Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002)	EN 600:1996	Date expired (31.08.2005)
CEN	EN ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)	EN ISO 4135:1996	Date expired (28.02.2002)
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 5356-2:2007 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2006)	EN 1281-2:1995	Date expired (29.02.2008)
CEN	EN ISO 5359:2008 Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)	EN 739:1998	30.06.2010
CEN	EN ISO 5360:2007 Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)	EN 1280-1:1997	Date expired (30.06.2008)
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 (31.01.2005)
CEN	EN ISO 5840:2005 Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)	EN 12006-1:1999	Date expired (30.06.2006)
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 (30.06.2004)
CEN	EN ISO 7396-1:2007 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)	EN 737-3:1998	30.04.2009
CEN	EN ISO 7396-2:2007 Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)	EN 737-2:1998	30.04.2009
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 7886-4:2006 Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)	—
CEN	EN ISO 8185:2007 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)	EN ISO 8185:1997	Date expired (31.01.2008)
CEN	EN ISO 8359:1996 Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)	—
CEN	EN ISO 8536-4:2007 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2007)	—
CEN	EN ISO 8835-2:2007 Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)	EN 740:1998	31.05.2009
CEN	EN ISO 8835-3:2007 Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)	EN 740:1998	31.05.2009
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 (30.09.2005)
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 (29.02.2000)
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 (29.02.2000)
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 (29.02.2000)
CEN	EN ISO 10328:2006 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006)	—
CEN	EN ISO 10524-1:2006 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)	EN 738-1:1997	31.10.2008
CEN	EN ISO 10524-2:2006 Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)	EN 738-2:1998	31.10.2008
CEN	EN ISO 10524-3:2006 Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)	EN 738-3:1998	31.10.2008
CEN	EN ISO 10524-4:2008 Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)	EN 738-4:1998	30.06.2010
CEN	EN ISO 10535:2006 Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)	EN ISO 10535:1998	Date expired (30.06.2007)
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 (31.01.2000)
	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 (31.01.2005)
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 (30.04.2004)
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 (30.04.2003)
	EN ISO 10993-4:2002/A1:2006	Note 3	Date expired (31.01.2007)
CEN	EN ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)	EN 30993-5:1994	Date expired (30.11.1999)
CEN	EN ISO 10993-6:2007 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)	EN 30993-6:1994	Date expired (31.10.2007)
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 (31.03.2003)
	EN ISO 10993-10:2002/A1:2006	Note 3	Date expired (31.01.2007)
CEN	EN ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)	EN ISO 10993-11:1995	Date expired (28.02.2007)
CEN	EN ISO 10993-12:2007 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)	EN ISO 10993-12:2004	Date expired (31.05.2008)
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