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Directive 93/42/EEC

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
(OJ No L 169/1 of 1993-07-12)

Publications in the Official Journal

Only the publications from 2001, 2002 and 2003 are listed hereunder. You can access the 198, 1999 and 2000 publications on http://europa.eu.int/eur-lex/en/archive/index.html

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


Summary list of titles and references of harmonised standards related to medical devices under Council Directive 93/42/EEC:

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 ĘC 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 ĘC 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

 

 

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