Corrigendum to Commission communication (page 9 of OJ C 182 of 2002-07-31)in relation to Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro diagnostic medical devices OJ C 273 page 11 of 2003-11-14
Commission communication in relation to Directive 93/42/EEC on medical devices and Directive 90/385/EEC on active implantable medical devices OJ C 270 page 2 of 2003-11-11
Commission communication in relation to Directive 93/42/EEC on medical devices OJ C 268 page 29 of 2003-11-07
Commission communication in relation to Directive 93/42/EEC on medical devices OJ C 247 page 7 of 2003-10-15
Commission communication in relation to Directive 93/42/EEC on medical devices OJ C 75 of 2003-03-27
Commission communication in relation to Directive 93/42/EEC on medical devices, Directive 98/79/EC on in-vitro diagnostic medical devices and Directive 90/385/EEC on active implantable medical devices - OJ C 32 page 14 of 2003-02-11
Commission communication in relation to Directive 93/42/EEC on medical devices - OJ C 321 page 2 of 2002-12-21
Commission communication in relation to Directive 93/42/EEC on medical devices - OJ C 310 page 12 of 2002-12-13
Commission communication in relation to Directive 93/42/EEC on medical devices - OJ C 310 pages 4-11 of 2002-12-13
Commission communication in relation to Directive 93/42/EEC on medical devices and to Directive 98/79/EC on in-vitro diagnostic medical devices - OJ C 182 page 8 of 2002-07-31
Commission communication in relation to Directive 93/42/EEC on medical devices and to Directive 98/79/EC on in-vitro diagnostic medical devices - OJ C 182 pages 9-10 of 2002-07-31 Important notice: EN 12180:2000
Commission communication in relation to Directive 93/42/EEC on medical devices - OJ C 319 page 10-12 of 2001-11-14
Commission communication in relation to Directive 93/42/EEC on medical devices and to Directive 98/79/EC on in-vitro diagnostic medical devices - OJ C 319 page 13 of 2001-11-14
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. It does 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 table includes the references of the harmonised standards from EN 285 to EN 30993-11. The second table starts at the references of harmonised standard EN 46001.
European
Standards
Bodies |
Standard reference |
Titles |
Ratification date |
Publication OJ |
CEN |
EN 285 |
Sterilization - Steam sterilizers - Large sterilizers |
1996 |
C 181 of 1999-06-26 |
CEN |
EN 375: 2001 |
Information supplied by the manufacturer with in vitro diagnostic reagents for professional use |
|
C 182 of 2002-07-31 |
CEN |
EN 376: 2002 |
Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing |
|
C 182 of 2002-07-31 |
CEN |
EN 455-1 |
Medical gloves for single use - Part 1 : Requirements and testing for freedom from holes |
2000 |
C 319 of 2001-11-14 |
CEN |
EN 455-2: 2000 |
Medical gloves for single use - Part 2: Requirements and testing for physical properties (including Corrigendum 1996) |
|
C 182 of 2002-07-31 |
CEN |
EN 455-3 |
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
1999 |
C 293 of 2000-10-14 |
CEN |
EN 475 |
Medical devices. Electrically generated alarm signals |
1995 |
C 181 of 1999-06-26 |
CEN |
EN 540 |
Clinical investigation of medical devices for humans |
1993 |
C 181 of 1999-06-26 |
CEN |
EN 550 |
Sterilization of medical devices - Validation and routine control of ethylene oxide sterilisation |
1994 |
C 181 of 1999-06-26 |
CEN |
EN 552 |
Sterilization of medical devices - Validation and routine control of sterilisation by irradiation |
1994 |
C 181 of 1999-06-26 |
CEN |
EN 552 A1 |
Sterilization of medical devices - Validation and routine control of sterilisation by irradiation |
1994
1999 |
C 288 of 1999-10-09 |
CEN |
EN 552: 1994/ A2:2000 |
Sterilisation of medical devices - Validation and routine control of sterilisation by irradiation |
|
C 182 of 2002-07-31 |
CEN |
EN 554 |
Sterilization of medical devices - Validation and routine control of sterilisation by moist heat |
1994 |
C 181 of 1999-06-26 |
CEN |
EN 556 |
Sterilization of medical devices - requirements for medical devices to be labelled sterile |
1994 |
C 181 of 1999-06-26 |
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 |
|
C 182 of 2002-07-31 |
CEN |
EN 591: 2001 |
Instructions for use in vitro diagnostic instruments for professional use |
|
C 182 of 2002-07-31 |
CEN |
EN 592: 2002 |
Instructions for use for in vitro diagnostic instruments for self-testing |
|
C 182 of 2002-07-31 |
CEN |
EN 600 |
Natural rubber latex male condoms |
1996 |
C 181 of 1999-06-26 |
CEN |
EN 724 |
Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices |
1994 |
C 181 of 1999-06-26 |
CEN |
EN 737-1 |
Medical gas pipeline systems - Part 1: Terminal units for compressed medical gases and vacuum |
1998 |
C 181 of 1999-06-26 |
CEN |
EN 737-2 |
Medical gas pipeline systems - Part 2: Anaesthetic gas scavening disposal systems - Basic requirements |
1998 |
C 181 of 1999-06-26 |
CEN |
EN 737-2/A1 |
Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems - Basic requirements |
1998
1999 |
C 293 of 2000-10-14 |
CEN |
EN 737-3 |
Medical gas pipeline systems - Part 3: Pipelines for compressed medical gases and vacuum |
1998 |
C 227 of 1999-08-10 |
CEN |
EN 737-3/A1 |
Medical gas pipeline systems - Part 3: Pipelines for compressed medical gases and vacuum |
1998
1999 |
C 293 of 2000-10-14 |
CEN |
EN 737-4 |
Medical gas pipeline systems - Part 4: Terminal units for anaesthetic gas scavenging systems |
1998 |
C 181 of 1999-06-26 |
CEN |
EN 738-1 |
Pressure regulators for use with medical gases - Part 1: pressure regulators and pressure regulators with flow metering devices |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 738-1:1997/ A1:2002 |
Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow metering devices |
|
C 310 of 2002-12-13 |
CEN |
EN 738-2 |
Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators |
1998 |
C 293 of 2000-10-14 |
CEN |
EN 738-3 |
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves |
1998 |
C 293 of 2000-10-14 |
CEN |
EN 738-3:1998/ A1:2002 |
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves |
|
C 310 of 2002-12-13 |
CEN |
EN 738-4 |
Pressure regulators for use with medical gases - Part 4: Low-pressure regulators intended for incorporation into medical equipment |
1998 |
C 293 of 2000-10-14 |
CEN |
EN 738-4:1998/ A1:2002 |
Pressure regulators for use with medical gases - Part 4: Low-pressure regulators intended for incorporation into medical equipment |
|
C 310 of 2002-12-13 |
CEN |
EN 739 |
Low pressure hose assemblies for use with medical gases |
1998 |
C 181 of 1999-06-26 |
CEN |
EN 739-1:1998/ A1:2002 |
Low-pressure hose assemblies for use with medical gases |
|
C 310 of 2002-12-13 |
CEN |
EN 740 |
Anaesthetic workstations and their modules - Particular requirements |
1998 |
C 227 of 1999-08-10 |
CEN |
EN 793 |
Particular requirements for safety of medical supply units |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 794-1 |
Lung ventilators - Part 1 : particular requirements for critical care ventilators |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 794-1: 1997/ A1:2000 |
Lung ventilators - Part 1: Particular requirements for critical care ventilators |
|
C 182 of 2002-07-31 |
CEN |
EN 794-2 |
Lung ventilators - Part 2 : particular requirements for home care use |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 794-3 |
Medical electrical equipment - Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators |
1998 |
C 181 of 1999-06-26 |
CEN |
EN 864 |
Medical electrical equipment : Capnometers for use with humans. Particular requirements |
1996 |
C 181 of 1999-06-26 |
CEN |
EN 865 |
Pulse oximeters - Particular requirements |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 867-2 |
Non-biological systems for use in sterilizers - Part 2 : process indicators (class A) |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 867-3 |
Non-biological systems for use in sterilizers - Part 3 : specification for class B indicators for use in the Bowie and Dick test |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 868-1 |
Packaging materials and systems for medical devices which are to be sterilized - Part 1 : general requirements and test methods |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 980
A1 |
Graphical symbols for use in the labelling of medical devices |
1996
1999 |
C 293 of 2000-10-14 |
CEN |
EN 980: 1996/ A1:1999 |
Graphical symbols for use in the labelling of medical devices |
|
C 319 of 2001-11-14 |
CEN |
EN 1041 |
Information supplied by the manufacturer with medical devices |
1998 |
C 181 of 1999-06-26 |
CEN |
EN 1060-1 |
Non-invasive sphygmomanometers - Part 1 : general requirement |
1995 |
C 181 of 1999-06-26 |
CEN |
EN 1060-1:1998/ A1:2002 |
Non-invasive sphygmomanometers - Part 1 : general requirement |
|
C 310 of 2002-12-13 |
CEN |
EN 1060-2 |
Non-invasive sphygmomanometers - Part 2 : supplementary requirements for mechanical sphygmomanometers |
1995 |
C 181 of 1999-06-26 |
CEN |
EN 1060-3 |
Non-invasive sphygmomanometers - Part 3 : supplementary requirements for electromechanical blood pressure measuring systems |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 1089-3 |
Transportable gas cylinders - Cylinder identification - Part 3 : colour coding |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 1089-3/A1 |
Transportable Gas cylinders - Gas cylinder identification - Part 3: Colour coding |
1997
1998 |
C 293 of 2000-10-14 |
CEN |
EN 1174-1 |
Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: requirements |
1996 |
C 181 of 1999-06-26 |
CEN |
EN 1174-2 |
Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: guidance |
1996 |
C 181 of 1999-06-26 |
CEN |
EN 1174-3 |
Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: guide to the methods for validation of microbiological techniques |
1996 |
C 181 of 1999-06-26 |
CEN |
EN 1280-1 |
Agent specific filling systems for anaesthetic vaporizers - Part 1 : rectangular keyed filling systems |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 1280-1: 1997/ A1:2000 |
Agent specific filling systems for anaesthetic vaporisers - Part 1: Rectangular keyed filling systems |
|
C 182 of 2002-07-31 |
CEN |
EN 1281-1 |
Anaesthetic and respiratory equipment - Conical connectors - Part 1 : cones and sockets |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 1281-1 Amendment1 |
Anaesthetic and respiratory equipment - Conical connectors - Part 1 : cones and sockets |
1997
1998 |
C 181 of 1999-06-26 |
CEN |
EN 1281-2 |
Anaesthetic and respiratory equipment - Conical connectors - Part 2 : screw-threaded weight-bearing connectors (ISO 5356-2:1987 modified) |
1995 |
C 181 of 1999-06-26 |
CEN |
EN 1282-1 |
Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1 : tubes for use in adults |
1996 |
C 181 of 1999-06-26 |
CEN |
EN 1282-2 |
Tracheostomy tubes - Part 2 : paediatric tubes |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 1422 |
Sterilisers for medical purposes - ethylene oxide sterilisers - requirements and test methods |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 1441
( superseded ) |
Medical devices - risk analysis |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 1618 |
Catheters other than intravascular catheters - test methods for common properties |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 1639 |
Dentistry - Medical devices for dentistry - Instruments |
1996 |
C 181 of 1999-06-26 |
CEN |
EN 1640 |
Dentistry - Medical devices for dentistry - Equipment |
1996 |
C 181 of 1999-06-26 |
CEN |
EN 1641 |
Dentistry - Medical devices for dentistry - Materials |
1996 |
C 181 of 1999-06-26 |
CEN |
EN 1642 |
Dentistry - Medical devices for dentistry - Dental implants |
1996 |
C 181 of 1999-06-26 |
CEN |
EN 1707 |
Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings |
1996 |
C 181 of 1999-06-26 |
CEN |
EN 1782 |
Tracheal tubes and connectors |
1998 |
C 181 of 1999-06-26 |
CEN |
EN 1789:1999/ A1:2003 |
Medical vehicles and their equipment - Road ambulances |
|
C 268 of 2003-11-07 |
CEN |
EN 1819 |
Laryngoscopes for tracheal intubation - particular requirements |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 1820 |
Anaesthetic reservoir bags |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 1865 |
Specifications for stretchers and other patient handling equipment used in road ambulances |
1999 |
C 293 of 2000-10-14 |
CEN |
EN 1970 |
Adjustable beds for disabled persons - Requirements and test methods |
2000 |
C 319 of 2001-11-14 |
CEN |
EN 1985 |
Walking aids - General requirements and test methods |
1998 |
C 227 of 1999-08-10 |
CEN |
EN ISO 4074: 2002 |
Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002) |
|
C 182 of 2002-07-31 |
CEN |
EN ISO 4135 |
Anaesthesiology - Vocabulary (ISO 4135:1995) |
1996 |
C 181 of 1999-06-26 |
CEN |
EN ISO 4135: 2001 |
Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001) |
|
C 182 of 2002-07-31 |
CEN |
EN ISO 8185 |
Humidifiers for medical use - General requirements for humidification systems |
1997 |
C 181 of 1999-06-26 |
CEN |
EN ISO 8359 |
Oxygen concentrators for medical use - Safety requirements |
1996 |
C 181 of 1999-06-26 |
CEN |
EN ISO 9360-1 |
Anaesthesic and respiratory equipment - Heat and moisture exhangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000) |
2000 |
C 319 of 2001-11-14 |
CEN |
EN ISO 9360-2:2002 |
Anaesthesic and respiratory equipment - Heat and moisture exhangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomised patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001) |
|
C 75 of 2003-03-27 |
CEN |
EN ISO 9703-3 |
Anaesthesia and respiratory care alarm signals - Part 3: Guidance on application of alarms (ISO 9703-3:1998) |
1998 |
C 227 of 1999-08-10 |
CEN |
EN ISO 10079-1 |
Medical suction equipment - Part 1 : electrically powered suction equipment - Safety requirements (ISO 10079-1:1991, including technical corrigendum 1:1992 and technical corrigendum 2:1993)
Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999) |
1996
1999 |
C 181 of 1999-06-26
C 293 of 2000-10-14
|
CEN |
EN ISO 10079-2 |
Medical suction equipment - Part 2 : manually powered suction equipment - (ISO 10079-2:1992)
Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999) |
1996
1999 |
C 181 of 1999-06-26
C 293 of 2000-10-14
|
CEN |
EN ISO 10079-3 |
Medical suction equipment - Part 3 : suction equipment powered from vacuum or pressure source (ISO 10079-3:1992)
Medical suction equipment – Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999) |
1996
1999 |
C 181 of 1999-06-26
C 293 of 2000-10-14
|
CEN |
EN ISO 10535 |
Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:1998) |
1998 |
C 293 of 2000-10-14 |
CEN |
EN ISO 10555-1 |
Sterile, single-use intravascular catheters - Part 1 : general requirements (ISO 10555-1:1995) |
1996 |
C 181 of 1999-06-26 |
CEN |
EN ISO 10555-1/A1 |
Sterile, single-use intra-vascular catheters - Part 1: General requirements (ISO 10555-1:1996/Amd 1:1999) |
1996
1999 |
C 293 of 2000-10-14 |
CEN |
EN ISO 10651-4:2002 |
Lung ventilators -Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) |
|
C 310 of 2002-12-13 |
CEN |
EN ISO 10993-1 |
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997) |
1997 |
C 181 of 1999-06-26 |
CEN |
EN ISO 10993-4: 2002 |
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002) |
|
C 321 of 2002-12-21 |
CEN |
EN ISO 10993-5 |
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999) |
1999 |
C 288 of 1999-10-09 |
CEN |
EN ISO 10993-7 |
Biological evaluation of medical devices - Part 7: ethylene oxide sterilisation residuals (ISO 10993-7:1995) |
1995 |
C 293 of 2000-10-14 |
CEN |
EN ISO 10993-8: 2001 |
Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000) |
|
C 182 of 2002-07-31 |
CEN |
EN ISO 10993-9 |
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999) |
1999 |
C 227 of 1999-08-12 |
CEN |
EN ISO 10993-10: 2002 |
Biological evaluation of medical devices - Part 10 : tests for irritation and sensitisation (ISO 10993-10:2002) |
|
C 321 of 2002-12-21 |
CEN |
EN ISO 10993-12 |
Biological evaluation of medical devices - Part 12 : sample preparation and reference materials (ISO 10993-12:1996) |
1996 |
C 181 of 1999-06-26 |
CEN |
EN ISO 10993-13 |
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) |
1998 |
C 227 of 1999-08-12 |
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) |
|
C 182 of 2002-07-31 |
CEN |
EN ISO 10993-15 |
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) |
2000 |
C 319 of 2001-11-14 |
CEN |
EN ISO 10993-16 |
Biological evaluation of medical devices - Part 16: toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997) |
1997 |
C 181 of 1999-06-26 |
CEN |
EN ISO 10993-17:2002 |
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
|
C 270 of 2003-11-11 |
CEN |
EN ISO 11196 |
Anaesthetic gas monitors (ISO 11196:1995 including technical corrigendum 1:1997) |
1997 |
C 181 of 1999-06-26 |
CEN |
EN ISO 11810: 2002 |
Optics and optical instruments - Lasers and laser-related equipment - Test method for the laser-resistance of surgical drapes and/or patient-protective covers (ISO 11810:2002) |
|
C 321 of 2002-12-21 |
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) |
|
C 268 of 2003-11-07 |
CEN |
EN 12006-1 |
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes |
1999 |
C 293 of 2000-10-14 |
CEN |
EN 12006-2 |
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits |
1998 |
C 181 of 1999-06-26 |
CEN |
EN 12006-3 |
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices |
1998 |
C 227 of 1999-08-10 |
CEN |
EN 12010 |
Non active surgical implants - Joint replacement implants - Particular requirements |
1998 |
C 181 of 1999-06-26 |
CEN |
EN 12011 |
Instrumentation to be used in association with non-active surgical implants - General requirements |
1998 |
C 181 of 1999-06-26 |
CEN |
EN 12180: 2000 |
Non-active surgical implants - Body contouring implants - Specific requirements for mammary implants |
|
C 182 of 2002-07-31 |
Important notice : The references of EN 12180: 2000, published on page 10 of OJ C 182 of 2002-07-31, will be deleted in a Commission Opinion in the Official Journal in the year 2004. |
CEN |
EN 12182 |
Technical aids for disabled persons - General requirements and test methods |
1999 |
C 293 of 2000-10-14 |
CEN |
EN 12183 |
Manually propelled wheelchairs - Requirements and test methods |
1999 |
C 227 of 1999-08-10 |
CEN |
EN 12184 |
Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods |
1999 |
C 227 of 1999-08-10 |
CEN |
EN 12218 |
Rail systems for supporting medical equipment |
1998 |
C 293 of 2000-10-14 |
CEN |
EN 12218:1998/ A1:2002 |
Rail systems for supporting medical equipment |
|
C 310 of 2002-12-13 |
CEN |
EN 12322: 1999/ A1:2001 |
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media |
|
C 182 of 2002-07-31 |
CEN |
EN 12342 |
Breathing tubes intended for use with anaesthetic apparatus and ventilators |
1998 |
C 181 of 1999-06-26 |
CEN |
EN 12442-1 |
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk |
2000 |
C 319 of 2001-11-14 |
CEN |
EN 12442-2 |
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, collection and handling |
2000 |
C 319 of 2001-11-14 |
CEN |
EN 12442-3 |
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 |
2000 |
C 319 of 2001-11-14 |
CEN |
EN 12470-1 |
Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device |
2000 |
C 293 of 2000-10-14 |
CEN |
EN 12470-2 |
Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers |
2000 |
C 319 of 2001-11-14 |
CEN |
EN 12470-3 |
Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
2000 |
C 293 of 2000-10-14 |
CEN |
EN 12470-4 |
Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement |
2000 |
C 319 of 2001-11-14 |
CEN |
EN 12470-5:2003 |
Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device) |
|
C 268 of 2003-11-07 |
CEN |
EN 12523 |
External limb prostheses and external orthoses - Requirements and test methods |
1998 |
C 227 of 1999-08-10 |
CEN |
EN 12563 |
Non-active surgical implants - Joint replacement implants - Specific requirements for hip joint replacement implants |
1998 |
C 227 of 1999-08-10 |
CEN |
EN 12564 |
Non-active surgical implants - Joint replacement implants - Specific requirements for knee joint replacement implants |
1998 |
C 227 of 1999-08-10 |
CEN |
EN 12598 |
Oxygen monitors for patient breathing mixtures - Particular requirements |
1999 |
C 227 of 1999-08-10 |
CEN |
EN 12718: 2001
corrigendum |
Corrigendum to page 9 of C 182 of 2002-07-31:
the references to EN 12718:2001 are deleted in OJ C 273 of 2003-11-14 |
CEN |
ENV 12719: 2001
corrigendum |
Corrigendum to page 9 of C 182 of 2002-07-31:
the references to ENV 12719:2001 are deleted in OJ C 273 of 2003-11-14 |
CEN |
EN ISO 12870 |
Ophtalmic optics - Spectacle frames - General requirements and test methods |
1997 |
C 181 of 1999-06-26 |
CEN |
EN 13014 |
Connections for gas sampling tubes to anaesthetic and respiratory equipment |
2000 |
C 319 of 2001-11-14 |
CEN |
EN 13220 |
Flow-metering devices for connection to terminal units of medical gas pipeline systems |
1998 |
C 293 of 2000-10-14 |
CEN |
EN 13221 |
High-pressure flexible connections for use with medical gases |
2000 |
C 319 of 2001-11-14 |
CEN |
EN 13328-1: 2001 |
Breathing system filters for anaesthetic and respiratory use - Part 1: Test method to assess filtration performance |
|
C 182 of 2002-07-31 |
CEN |
EN 13328-2:2002 |
Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects |
|
C 75 of 2003-03-27 |
CEN |
EN ISO 13485:
2000 |
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001:1994 (revision of EN 46001:1996) |
|
C 182 of 2002-07-31 |
- Reference of the superseded standard: EN 46001
- Date of cessation of presumption of conformity of the superseded standard: 2004-03-01 ( Note 1 )
|
CEN |
EN ISO 13488:
2000 |
Quality systems - Medical devices - Particular requirements for the application of ISO 9002:1994 (revision of EN 46002 :1996) |
|
C 182 of 2002-07-31 |
- Reference of the superseded standard: EN 46002
- Date of cessation of presumption of conformity of the superseded standard: 2004-03-01 ( Note 1 )
|
CEN |
EN 13503-8 |
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO/FDIS 11979-8:1999, modified) |
2000 |
C 319 of 2001-11-14 |
CEN |
EN 13544-1: 2001 |
Respiratory therapy equipment - Part 1: Nebulising systems and their components |
|
C 182 of 2002-07-31 |
CEN |
EN 13544-2: 2002 |
Respiratory therapy equipment - Part 2: Tubing and connectors |
|
C 321 of 2002-12-21 |
CEN |
EN 13544-3: 2001 |
Respiratory therapy equipment - Part 3: Air entrainment devices |
|
C 182 of 2002-07-31 |
CEN |
EN 13718-1: 2002 |
Air, water and difficult terrain ambulances - Part 1: Medical device interface requirements for the continuity of patient care |
|
C 321 of 2002-12-21 |
CEN |
EN 13718-2:2002 |
Air, water and difficult terrain ambulances - Part 2: Operational and technical requirements for continuity of patient care |
|
C 75 of 2003-03-27 |
CEN |
EN 13726-1:2002 |
Test methods for primary wound dressings - Part 1: Aspects of absorbency |
|
C 75 of 2003-03-27 |
CEN |
EN 13726-2:2002 |
Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings |
|
C 75 of 2003-03-27 |
CEN |
EN 13726-3:2003 |
Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness |
|
C 268 of 2003-11-07 |
CEN |
EN 13726-4:2003 |
Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability |
|
C 268 of 2003-11-07 |
CEN |
EN 13867:
2002 |
Concentrates for haemodialysis and related therapies |
|
C 321 of 2002-12-21 |
CEN |
EN 14079:2003 |
Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze |
|
C 268 of 2003-11-07 |
CEN |
EN ISO 14155-1:2003 |
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) |
|
C 270 of 2003-11-11 |
CEN |
EN ISO 14155-2:2003 |
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) |
|
C 270 of 2003-11-11 |
CEN |
EN ISO 14160 |
Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants |
1998 |
C 181 of 1999-06-26 |
CEN |
EN 14180:2003 |
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
|
C 268 of 2003-11-07 |
CEN |
EN ISO 14534: 2002 |
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002) |
|
C 310 of 2002-12-13 |
CEN |
EN ISO 14602 |
Non-active surgical implants - Implants for Osteosynthesis - Particular requirements |
1998 |
C 181 of 1999-06-26 |
CEN |
EN ISO 14630 |
Non-active surgical implants - General requirements |
1997 |
C 181 of 1999-06-26 |
CEN |
EN ISO 14889: 2003 |
Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003) |
|
C 268 of 2003-11-07 |
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) |
|
C 182 of 2002-07-31 |
CEN |
EN ISO 14971:
2000 |
Medical devices - Application of risk management to medical devices (ISO 14971:2000) |
|
C 182 of 2002-07-31 |
- Reference of the superseded standard: EN 1441
- Date of cessation of presumption of conformity of the superseded standard: 2004-04-01 ( Note 1 )
|
CEN |
EN ISO 15004 |
Ophthalmic instruments – fundamental requirements and test methods (ISO 594-1: 1986) |
1997 |
C 181 of 1999-06-26 |
CEN |
EN ISO 15225: 2000 |
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000) |
|
C 182 of 2002-07-31 |
CEN |
EN ISO 17510-2:2003 |
Sleep apnoea breathing therapy - Part 2 : Masks and application accessories (ISO 17510?2:2003) |
|
C 268 of 2003-11-07 |
CEN |
EN 20594-1 |
Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1 : General requirements (ISO 594-1:1986) |
1993 |
C 181 of 1999-06-26 |
CEN |
EN 20594-1 A1 |
Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986) |
1993,1997 |
C 227 of 1999-08-10 |
CEN |
EN 27740 |
Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) |
1992 |
C 181 of 1999-06-26 |
CEN |
EN 27740 A1 |
Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) |
1992,1997 |
C 227 of 1999-08-10 |
CEN |
EN 30993-3 |
Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:1992) |
1993 |
C 181 of 1999-06-26 |
CEN |
EN 30993-4 |
Biological evaluation of medical devices - Part 4 : selection of tests for interactions with blood (ISO 10993-4:1992) |
1993 |
C 181 of 1999-06-26 |
CEN |
EN 30993-5 |
Biological evaluation of medical devices - Part 5 : tests for cytotoxicity - in vitro methods (ISO 10993-5:1992) |
1993 |
C 181 of 1999-06-26 |
CEN |
EN 30993-6 |
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:1994) |
1994 |
C 181 of 1999-06-26 |
CEN |
EN 30993-11 |
Biological evaluation of medical devices - Part 11: tests for systemic toxicity (ISO 10993-11:1993) |
1995 |
C 181 of 1999-06-26 |
