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Normativa Armonizada

Normativa armonizada con la directiva 93/42/EEC

https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en

ESO(1)

Reference and title of the standard
(and reference document)

First publication OJ

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard
Note 1

CEN EN 285:2006+A2:2009

Sterilization – Steam sterilizers – Large sterilizers

02/12/2009

EN 285:2006+A1:2008

Note 2.1

21/03/2010

CEN EN 455-1:2000

Medical gloves for single use – Part 1: Requirements and testing for freedom from holes

30/09/2005

EN 455-1:1993

Note 2.1

30/04/2001

CEN EN 455-2:2009+A2:2013

Medical gloves for single use – Part 2: Requirements and testing for physical properties

16/05/2014

EN 455-2:2009+A1:2011

Note 2.1

31/10/2014

CEN EN 455-3:2006

Medical gloves for single use – Part 3: Requirements and testing for biological evaluation

09/08/2007

EN 455-3:1999

Note 2.1

30/06/2007

CEN EN 455-4:2009

Medical gloves for single use – Part 4: Requirements and testing for shelf life determination

07/07/2010

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

31/07/2002

EN 556:1994 + A1:1998

Note 2.1

30/04/2002

EN 556-1:2001/AC:2006

 

15/11/2006

CEN EN 556-2:2015 (new)

Sterilization of medical devices – Requirements for medical devices to be designated ”STERILE” – Part 2: Requirements for aseptically processed medical devices

This is the first publication

EN 556-2:2003

Note 2.1

30/06/2016

CEN EN 794-3:1998+A2:2009

Lung ventilators – Part 3: Particular requirements for emergency and transport ventilators

07/07/2010

EN 794-3:1998

Note 2.1

21/03/2010

CEN EN 980:2008

Symbols for use in the labelling of medical devices

23/07/2008

EN 980:2003

Note 2.1

31/05/2010

CEN EN 1041:2008

Information supplied by the manufacturer of medical devices

19/02/2009

EN 1041:1998

Note 2.1

31/08/2011

CEN EN 1060-3:1997+A2:2009

Non-invasive sphygmomanometers – Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

07/07/2010

EN 1060-3:1997

Note 2.1

31/05/2010

CEN EN 1060-4:2004

Non-invasive sphygmomanometers – Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers

30/09/2005

CEN EN ISO 1135-4:2011

Transfusion equipment for medical use – Part 4: Transfusion sets for single use (ISO 1135-4:2010)

27/04/2012

EN ISO 1135-4:2010

Note 2.1

30/04/2012

CEN EN 1282-2:2005+A1:2009

Tracheostomy tubes – Part 2: Paediatric tubes (ISO 5366-3:2001, modified)

07/07/2010

EN 1282-2:2005

Note 2.1

21/03/2010

CEN EN 1422:1997+A1:2009

Sterilizers for medical purposes – Ethylene oxide sterilizers – Requirements and test methods

02/12/2009

EN 1422:1997

Note 2.1

21/03/2010

CEN EN 1618:1997

Catheters other than intravascular catheters – Test methods for common properties

09/05/1998

CEN EN 1639:2009

Dentistry – Medical devices for dentistry – Instruments

07/07/2010

EN 1639:2004

Note 2.1

30/04/2010

CEN EN 1640:2009

Dentistry – Medical devices for dentistry – Equipment

07/07/2010

EN 1640:2004

Note 2.1

30/04/2010

CEN EN 1641:2009

Dentistry – Medical devices for dentistry – Materials

07/07/2010

EN 1641:2004

Note 2.1

30/04/2010

CEN EN 1642:2011

Dentistry – Medical devices for dentistry – Dental implants

27/04/2012

EN 1642:2009

Note 2.1

30/04/2012

CEN EN 1707:1996

Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment – Lock fittings

17/05/1997

CEN EN 1782:1998+A1:2009

Tracheal tubes and connectors

07/07/2010

EN 1782:1998

Note 2.1

21/03/2010

CEN EN 1789:2007+A1:2010

Medical vehicles and their equipment – Road ambulances

18/01/2011

CEN EN 1820:2005+A1:2009

Anaesthetic reservoir bags (ISO 5362:2000, modified)

07/07/2010

EN 1820:2005

Note 2.1

21/03/2010

CEN EN 1865-1:2010+A1:2015(new)

Patient handling equipment used in road ambulances – Part 1: General stretcher systems and patient handling equipment

This is the first publication

CEN EN 1865-2:2010+A1:2015(new)

Patient handling equipment used in road ambulances – Part 2: Power assisted stretcher

This is the first publication

CEN EN 1865-3:2012

Patient handling equipment used in road ambulances – Part 3: Heavy duty stretcher

30/08/2012

EN 1865:1999

Note 2.1

31/12/2012

CEN EN 1865-4:2012

Patient handling equipment used in road ambulances – Part 4: Foldable patient transfer chair

30/08/2012

EN 1865:1999

Note 2.1

31/10/2012

CEN EN 1865-5:2012

Patient handling equipment used in road ambulances – Part 5: Stretcher support

30/08/2012

EN 1865:1999

Note 2.1

31/12/2012

CEN EN 1985:1998

Walking aids – General requirements and test methods

10/08/1999

This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CEN EN ISO 3826-2:2008

Plastics collapsible containers for human blood and blood components – Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008)

19/02/2009

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)

27/02/2008

CEN EN ISO 3826-4:2015 (new)

Plastics collapsible containers for human blood and blood components – Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)

This is the first publication

CEN EN ISO 4074:2002

Natural latex rubber condoms – Requirements and test methods (ISO 4074:2002)

31/07/2002

EN 600:1996

Note 2.1

31/08/2005

CEN EN ISO 4135:2001

Anaesthetic and respiratory equipment – Vocabulary (ISO 4135:2001)

31/07/2002

EN ISO 4135:1996

Note 2.1

28/02/2002

CEN EN ISO 5359:2008

Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)

23/07/2008

EN 739:1998

Note 2.1

30/06/2010

EN ISO 5359:2008/A1:2011

 

30/08/2012

Note 3

30/06/2012

CEN EN ISO 5360:2009

Anaesthetic vaporizers – Agent-specific filling systems (ISO 5360:2006)

02/12/2009

EN ISO 5360:2007

Note 2.1

21/03/2010

CEN EN ISO 5366-1:2009

Anaesthetic and respiratory equipment – Tracheostomy tubes – Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)

02/12/2009

EN ISO 5366-1:2004

Note 2.1

21/03/2010

CEN EN ISO 5840:2009

Cardiovascular implants – Cardiac valve prostheses (ISO 5840:2005)

02/12/2009

EN ISO 5840:2005

Note 2.1

21/03/2010

CEN EN ISO 7197:2009

Neurosurgical implants – Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)

02/12/2009

EN ISO 7197:2006

Note 2.1

21/03/2010

CEN EN ISO 7376:2009

Anaesthetic and respiratory equipment – Laryngoscopes for tracheal intubation (ISO 7376:2009)

02/12/2009

EN ISO 7376:2009

Note 2.1

21/03/2010

CEN EN ISO 7396-1:2007

Medical gas pipeline systems – Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)

09/08/2007

EN 737-3:1998

Note 2.1

30/04/2009

EN ISO 7396-1:2007/A1:2010

 

07/07/2010

Note 3

31/07/2010

EN ISO 7396-1:2007/A2:2010

 

07/07/2010

Note 3

31/08/2010

CEN EN ISO 7396-2:2007

Medical gas pipeline systems – Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)

09/08/2007

EN 737-2:1998

Note 2.1

30/04/2009

CEN EN ISO 7886-3:2009

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

07/07/2010

EN ISO 7886-3:2005

Note 2.1

21/03/2010

CEN EN ISO 7886-4:2009

Sterile hypodermic syringes for single use – Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)

07/07/2010

EN ISO 7886-4:2006

Note 2.1

21/03/2010

CEN EN ISO 8185:2009

Respiratory tract humidifiers for medical use – Particular requirements for respiratory humidification systems (ISO 8185:2007)

02/12/2009

EN ISO 8185:2007

Note 2.1

21/03/2010

CEN EN ISO 8359:2009

Oxygen concentrators for medical use – Safety requirements (ISO 8359:1996)

02/12/2009

EN ISO 8359:1996

Note 2.1

21/03/2010

EN ISO 8359:2009/A1:2012

 

16/01/2015

Note 3

31/01/2013

CEN EN ISO 8835-2:2009

Inhalational anaesthesia systems – Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)

02/12/2009

EN ISO 8835-2:2007

Note 2.1

21/03/2010

CEN EN ISO 8835-3:2009

Inhalational anaesthesia systems – Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)

02/12/2009

EN ISO 8835-3:2007

Note 2.1

21/03/2010

EN ISO 8835-3:2009/A1:2010

 

13/05/2011

Note 3

30/04/2011

CEN EN ISO 8835-4:2009

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

02/12/2009

EN ISO 8835-4:2004

Note 2.1

21/03/2010

CEN EN ISO 8835-5:2009

Inhalational anaesthesia systems – Part 5: Anaesthetic ventilators (ISO 8835-5:2004)

02/12/2009

EN ISO 8835-5:2004

Note 2.1

21/03/2010

CEN EN ISO 9170-1:2008

Terminal units for medical gas pipeline systems – Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008)

19/02/2009

EN 737-1:1998

Note 2.1

31/07/2010

CEN EN ISO 9170-2:2008

Terminal units for medical gas pipeline systems – Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)

19/02/2009

EN 737-4:1998

Note 2.1

31/07/2010

CEN EN ISO 9360-1:2009

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)

02/12/2009

EN ISO 9360-1:2000

Note 2.1

21/03/2010

CEN EN ISO 9360-2:2009

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)

02/12/2009

EN ISO 9360-2:2002

Note 2.1

21/03/2010

CEN EN ISO 9713:2009

Neurosurgical implants – Self-closing intracranial aneurysm clips (ISO 9713:2002)

02/12/2009

EN ISO 9713:2004

Note 2.1

21/03/2010

CEN EN ISO 10079-1:2009

Medical suction equipment – Part 1: Electrically powered suction equipment – Safety requirements (ISO 10079-1:1999)

02/12/2009

EN ISO 10079-1:1999

Note 2.1

21/03/2010

CEN EN ISO 10079-2:2009

Medical suction equipment – Part 2: Manually powered suction equipment (ISO 10079-2:1999)

02/12/2009

EN ISO 10079-2:1999

Note 2.1

21/03/2010

CEN EN ISO 10079-3:2009

Medical suction equipment – Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)

02/12/2009

EN ISO 10079-3:1999

Note 2.1

21/03/2010

CEN EN ISO 10328:2006

Prosthetics – Structural testing of lower-limb prostheses – Requirements and test methods (ISO 10328:2006)

09/08/2007

This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
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)

02/06/2006

EN 738-1:1997

Note 2.1

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)

07/06/2009

EN 738-2:1998

Note 2.1

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)

07/09/2006

EN 738-3:1998

Note 2.1

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)

23/07/2008

EN 738-4:1998

Note 2.1

30/06/2010

CEN EN ISO 10535:2006

Hoists for the transfer of disabled persons – Requirements and test methods (ISO 10535:2006)

09/08/2007

EN ISO 10535:1998

Note 2.1

30/06/2007

This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CEN EN ISO 10555-1:2009

Sterile, single-use intravascular catheters – Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)

02/12/2009

EN ISO 10555-1:1996

Note 2.1

21/03/2010

CEN EN ISO 10651-2:2009

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)

02/12/2009

EN ISO 10651-2:2004

Note 2.1

21/03/2010

CEN EN ISO 10651-4:2009

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

02/12/2009

EN ISO 10651-4:2002

Note 2.1

21/03/2010

CEN EN ISO 10651-6:2009

Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)

02/12/2009

EN ISO 10651-6:2004

Note 2.1

21/03/2010

CEN EN ISO 10993-1:2009

Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

02/12/2009

EN ISO 10993-1:2009

Note 2.1

21/03/2010

EN ISO 10993-1:2009/AC:2010

 

18/01/2011

CEN EN ISO 10993-3:2014

Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

10/07/2015

EN ISO 10993-3:2009

Note 2.1

The date of this publication
()

CEN EN ISO 10993-4:2009

Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)

02/12/2009

EN ISO 10993-4:2002

Note 2.1

21/03/2010

CEN EN ISO 10993-5:2009

Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

02/12/2009

EN ISO 10993-5:1999

Note 2.1

31/12/2009

CEN EN ISO 10993-6:2009

Biological evaluation of medical devices – Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

02/12/2009

EN ISO 10993-6:2007

Note 2.1

21/03/2010

CEN EN ISO 10993-7:2008

Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

19/02/2009

EN ISO 10993-7:2008/AC:2009

 

07/07/2010

CEN EN ISO 10993-9:2009

Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

02/12/2009

EN ISO 10993-9:2009

Note 2.1

21/03/2010

CEN EN ISO 10993-11:2009

Biological evaluation of medical devices – Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

02/12/2009

EN ISO 10993-11:2006

Note 2.1

21/03/2010

CEN EN ISO 10993-12:2012

Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

24/01/2013

EN ISO 10993-12:2009

Note 2.1

31/01/2013

CEN EN ISO 10993-13:2010

Biological evaluation of medical devices – Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

18/01/2011

EN ISO 10993-13:2009

Note 2.1

31/12/2010

CEN EN ISO 10993-14:2009

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

02/12/2009

EN ISO 10993-14:2001

Note 2.1

21/03/2010

CEN EN ISO 10993-15:2009

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

02/12/2009

EN ISO 10993-15:2000

Note 2.1

21/03/2010

CEN EN ISO 10993-16:2010

Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

07/07/2010

EN ISO 10993-16:2009

Note 2.1

31/08/2010

CEN EN ISO 10993-17:2009

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

02/12/2009

EN ISO 10993-17:2002

Note 2.1

21/03/2010

CEN EN ISO 10993-18:2009

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

02/12/2009

EN ISO 10993-18:2005

Note 2.1

21/03/2010

CEN EN ISO 11135-1:2007

Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)

09/08/2007

EN 550:1994

Note 2.1

31/05/2010

CEN EN ISO 11137-1:2015 (new)

Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

This is the first publication

EN ISO 11137-1:2006

Note 2.1

30/06/2016

CEN EN ISO 11137-2:2015 (new)

Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

This is the first publication

EN ISO 11137-2:2013

Note 2.1

30/06/2016

CEN EN ISO 11138-2:2009

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

02/12/2009

EN ISO 11138-2:2006

Note 2.1

21/03/2010

CEN EN ISO 11138-3:2009

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

02/12/2009

EN ISO 11138-3:2006

Note 2.1

21/03/2010

CEN EN ISO 11140-1:2009

Sterilization of health care products – Chemical indicators – Part 1: General requirements (ISO 11140-1:2005)

02/12/2009

EN ISO 11140-1:2005

Note 2.1

21/03/2010

CEN EN ISO 11140-3:2009

Sterilization of health care products – Chemical indicators – Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)

02/12/2009

EN ISO 11140-3:2007

Note 2.1

21/03/2010

CEN EN ISO 11197:2009

Medical supply units (ISO 11197:2004)

02/12/2009

EN ISO 11197:2004

Note 2.1

21/03/2010

CEN EN ISO 11607-1:2009

Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

02/12/2009

EN ISO 11607-1:2006

Note 2.1

21/03/2010

CEN EN ISO 11607-2:2006

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

07/09/2006

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)

07/09/2006

EN 1174-1:1996
EN 1174-2:1996
EN 1174-3:1996

Note 2.1

31/10/2006

EN ISO 11737-1:2006/AC:2009

 

02/12/2009

CEN EN ISO 11737-2:2009

Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

07/07/2010

CEN EN ISO 11810-1:2009

Lasers and laser-related equipment – Test method and classification for the laser resistance of surgical drapes and/or patient protective covers – Part 1: Primary ignition and penetration (ISO 11810-1:2005)

02/12/2009

CEN EN ISO 11810-2:2009

Lasers and laser-related equipment – Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers – Part 2: Secondary ignition (ISO 11810-2:2007)

02/12/2009

EN ISO 11810-2:2007

Note 2.1

21/03/2010

CEN EN ISO 11979-8:2009

Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirements (ISO 11979-8:2006)

02/12/2009

EN ISO 11979-8:2006

Note 2.1

21/03/2010

CEN EN ISO 11990-1:2014

Lasers and laser-related equipment – Determination of laser resistance of tracheal tubes – Part 1: Tracheal tube shaft (ISO 11990-1:2011)

10/07/2015

CEN EN ISO 11990-2:2014

Lasers and laser-related equipment – Determination of laser resistance of tracheal tubes – Part 2: Tracheal tube cuffs (ISO 11990-2:2010)

10/07/2015

CEN EN 12006-2:1998+A1:2009

Non active surgical implants – Particular requirements for cardiac and vascular implants – Part 2: Vascular prostheses including cardiac valve conduits

02/12/2009

EN 12006-2:1998

Note 2.1

21/03/2010

CEN EN 12006-3:1998+A1:2009

Non active surgical implants – Particular requirements for cardiac and vascular implants – Part 3: Endovascular devices

02/12/2009

EN 12006-3:1998

Note 2.1

21/03/2010

CEN EN 12183:2009

Manual wheelchairs – Requirements and test methods

07/07/2010

CEN EN 12184:2009

Electrically powered wheelchairs, scooters and their chargers – Requirements and test methods

07/07/2010

CEN EN 12342:1998+A1:2009

Breathing tubes intended for use with anaesthetic apparatus and ventilators

07/07/2010

EN 12342:1998

Note 2.1

21/03/2010

CEN EN 12470-1:2000+A1:2009

Clinical thermometers – Part 1: Metallic liquid-in-glass thermometers with maximum device

02/12/2009

EN 12470-1:2000

Note 2.1

21/03/2010

CEN EN 12470-2:2000+A1:2009

Clinical thermometers – Part 2: Phase change type (dot matrix) thermometers

02/12/2009

EN 12470-2:2000

Note 2.1

21/03/2010

CEN EN 12470-3:2000+A1:2009

Clinical thermometers – Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device

02/12/2009

EN 12470-3:2000

Note 2.1

21/03/2010

CEN EN 12470-4:2000+A1:2009

Clinical thermometers – Part 4: Performance of electrical thermometers for continuous measurement

02/12/2009

EN 12470-4:2000

Note 2.1

21/03/2010

CEN EN 12470-5:2003

Clinical thermometers – Part 5: Performance of infra-red ear thermometers (with maximum device)

07/11/2003

This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CEN EN ISO 12870:2009

Ophthalmic optics – Spectacle frames – Requirements and test methods (ISO 12870:2004)

02/12/2009

EN ISO 12870:2004

Note 2.1

21/03/2010

CEN EN 13060:2014

Small steam sterilizers

10/07/2015

EN 13060:2004+A2:2010

Note 2.1

The date of this publication
()

CEN EN ISO 13408-1:2015 (new)

Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

This is the first publication

EN ISO 13408-1:2011

Note 2.1

30/06/2016

CEN EN ISO 13408-2:2011

Aseptic processing of health care products – Part 2: Filtration (ISO 13408-2:2003)

19/08/2011

EN 13824:2004

Note 2.1

31/12/2011

CEN EN ISO 13408-3:2011

Aseptic processing of health care products – Part 3: Lyophilization (ISO 13408-3:2006)

19/08/2011

EN 13824:2004

Note 2.1

31/12/2011

CEN EN ISO 13408-4:2011

Aseptic processing of health care products – Part 4: Clean-in-place technologies (ISO 13408-4:2005)

19/08/2011

EN 13824:2004

Note 2.1

31/12/2011

CEN EN ISO 13408-5:2011

Aseptic processing of health care products – Part 5: Sterilization in place (ISO 13408-5:2006)

19/08/2011

EN 13824:2004

Note 2.1

31/12/2011

CEN EN ISO 13408-6:2011

Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2005)

19/08/2011

EN 13824:2004

Note 2.1

31/12/2011

CEN EN ISO 13408-7:2015 (new)

Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

This is the first publication

CEN EN ISO 13485:2012

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

30/08/2012

EN ISO 13485:2003

Note 2.1

31/08/2012

EN ISO 13485:2012/AC:2012

 

30/08/2012

CEN EN 13544-1:2007+A1:2009

Respiratory therapy equipment – Part 1: Nebulizing systems and their components

07/07/2010

EN 13544-1:2007

Note 2.1

21/03/2010

CEN EN 13544-2:2002+A1:2009

Respiratory therapy equipment – Part 2: Tubing and connectors

07/07/2010

EN 13544-2:2002

Note 2.1

21/03/2010

CEN EN 13544-3:2001+A1:2009

Respiratory therapy equipment – Part 3: Air entrainment devices

07/07/2010

EN 13544-3:2001

Note 2.1

21/03/2010

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)

30/09/2005

CEN EN 13718-1:2008

Medical vehicles and their equipment – Air ambulances – Part 1: Requirements for medical devices used in air ambulances

19/02/2009

EN 13718-1:2002

Note 2.1

28/02/2009

CEN EN 13718-2:2015

Medical vehicles and their equipment – Air ambulances – Part 2: Operational and technical requirements for air ambulances

10/07/2015

CEN EN 13726-1:2002

Test methods for primary wound dressings – Part 1: Aspects of absorbency

27/03/2003

EN 13726-1:2002/AC:2003

 

02/12/2009

CEN EN 13726-2:2002

Test methods for primary wound dressings – Part 2: Moisture vapour transmission rate of permeable film dressings

27/03/2003

CEN EN 13727:2012

Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of bactericidal activity in the medical area – Test method and requirements (phase 2, step 1)

30/08/2012

EN 13727:2003

Note 2.1

30/11/2012

CEN EN 13867:2002+A1:2009

Concentrates for haemodialysis and related therapies

02/12/2009

EN 13867:2002

Note 2.1

21/03/2010

CEN EN 13976-1:2011

Rescue systems – Transportation of incubators – Part 1: Interface conditions

19/08/2011

EN 13976-1:2003

Note 2.1

30/11/2011

CEN EN 13976-2:2011

Rescue systems – Transportation of incubators – Part 2: System requirements

19/08/2011

EN 13976-2:2003

Note 2.1

30/11/2011

CEN EN 14079:2003

Non-active medical devices – Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

30/09/2005

CEN EN 14139:2010

Ophthalmic optics – Specifications for ready-to-wear spectacles

18/01/2011

CEN EN ISO 14155:2011

Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2011)

27/04/2012

EN ISO 14155:2011

Note 2.1

30/04/2012

CEN EN 14180:2003+A2:2009

Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing

07/07/2010

EN 14180:2003+A1:2009

Note 2.1

21/03/2010

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)

30/09/2005

CEN EN ISO 14408:2009

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

02/12/2009

EN ISO 14408:2005

Note 2.1

21/03/2010

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)

15/11/2006

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)

15/11/2006

CEN EN 14563:2008

Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area – Test method and requirements (phase 2, step 2)

19/02/2009

CEN EN ISO 14602:2011

Non-active surgical implants – Implants for osteosynthesis – Particular requirements (ISO 14602:2010)

27/04/2012

EN ISO 14602:2010

Note 2.1

30/04/2012

CEN EN ISO 14607:2009

Non-active surgical implants – Mammary implants – Particular requirements (ISO 14607:2007)

02/12/2009

EN ISO 14607:2007

Note 2.1

21/03/2010

CEN EN ISO 14630:2009

Non-active surgical implants – General requirements (ISO 14630:2008)

02/12/2009

EN ISO 14630:2008

Note 2.1

21/03/2010

CEN EN 14683:2005

Surgical masks – Requirements and test methods

02/06/2006

CEN EN ISO 14889:2009

Ophthalmic optics – Spectacle lenses – Fundamental requirements for uncut finished lenses (ISO 14889:2003)

02/12/2009

EN ISO 14889:2003

Note 2.1

21/03/2010

CEN EN 14931:2006

Pressure vessels for human occupancy (PVHO) – Multi-place pressure chamber systems for hyperbaric therapy – Performance, safety requirements and testing

15/11/2006

CEN EN ISO 14937:2009

Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

07/07/2010

EN ISO 14937:2000

Note 2.1

30/04/2010

CEN EN ISO 14971:2012

Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

30/08/2012

EN ISO 14971:2009

Note 2.1

30/08/2012

CEN EN ISO 15001:2011

Anaesthetic and respiratory equipment – Compatibility with oxygen (ISO 15001:2010)

27/04/2012

EN ISO 15001:2010

Note 2.1

30/04/2012

CEN EN ISO 15002:2008

Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)

19/02/2009

EN 13220:1998

Note 2.1

31/07/2010

CEN EN ISO 15004-1:2009

Ophthalmic instruments – Fundamental requirements and test methods – Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)

02/12/2009

EN ISO 15004-1:2006

Note 2.1

21/03/2010

CEN EN ISO 15747:2011

Plastic containers for intravenous injections (ISO 15747:2010)

27/04/2012

EN ISO 15747:2010

Note 2.1

30/04/2012

CEN EN ISO 15798:2010

Ophthalmic implants – Ophthalmic viscosurgical devices (ISO 15798:2010)

07/07/2010

CEN EN ISO 15883-1:2009

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

02/12/2009

EN ISO 15883-1:2006

Note 2.1

21/03/2010

CEN EN ISO 15883-2:2009

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)

02/12/2009

EN ISO 15883-2:2006

Note 2.1

21/03/2010

CEN EN ISO 15883-3:2009

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

02/12/2009

EN ISO 15883-3:2006

Note 2.1

21/03/2010

CEN EN ISO 15883-4:2009

Washer-disinfectors – Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)

02/12/2009

EN ISO 15883-4:2008

Note 2.1

21/03/2010

CEN EN 15986:2011

Symbol for use in the labelling of medical devices – Requirements for labelling of medical devices containing phthalates

13/05/2011

CEN EN ISO 16061:2009

Instrumentation for use in association with non-active surgical implants – General requirements (ISO 16061:2008, Corrected version 2009-03-15)

07/07/2010

EN ISO 16061:2008

Note 2.1

28/02/2010

CEN EN ISO 16201:2006

Technical aids for disabled persons – Environmental control systems for daily living (ISO 16201:2006)

19/02/2009

CEN EN ISO 17510-1:2009

Sleep apnoea breathing therapy – Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)

02/12/2009

EN ISO 17510-1:2007

Note 2.1

21/03/2010

CEN EN ISO 17510-2:2009

Sleep apnoea breathing therapy – Part 2: Masks and application accessories (ISO 17510-2:2007)

02/12/2009

EN ISO 17510-2:2007

Note 2.1

21/03/2010

CEN EN ISO 17664:2004

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

30/09/2005

CEN EN ISO 17665-1:2006

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

15/11/2006

EN 554:1994

Note 2.1

31/08/2009

CEN EN ISO 18777:2009

Transportable liquid oxygen systems for medical use – Particular requirements (ISO 18777:2005)

02/12/2009

EN ISO 18777:2005

Note 2.1

21/03/2010

CEN EN ISO 18778:2009

Respiratory equipment – Infant monitors – Particular requirements (ISO 18778:2005)

02/12/2009

EN ISO 18778:2005

Note 2.1

21/03/2010

CEN EN ISO 18779:2005

Medical devices for conserving oxygen and oxygen mixtures – Particular requirements (ISO 18779:2005)

30/09/2005

CEN EN ISO 19054:2006

Rail systems for supporting medical equipment (ISO 19054:2005)

07/09/2006

EN 12218:1998

Note 2.1

30/06/2008

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)

18/11/1995

EN 20594-1:1993/AC:1996

 

02/12/2009

EN 20594-1:1993/A1:1997

 

10/08/1999

Note 3

31/05/1998

CEN EN ISO 21534:2009

Non-active surgical implants – Joint replacement implants – Particular requirements (ISO 21534:2007)

02/12/2009

EN ISO 21534:2007

Note 2.1

21/03/2010

CEN EN ISO 21535:2009

Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants (ISO 21535:2007)

02/12/2009

EN ISO 21535:2007

Note 2.1

21/03/2010

CEN EN ISO 21536:2009

Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants (ISO 21536:2007)

02/12/2009

EN ISO 21536:2007

Note 2.1

21/03/2010

CEN EN ISO 21649:2009

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

07/07/2010

EN ISO 21649:2006

Note 2.1

21/03/2010

CEN EN ISO 21969:2009

High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)

07/07/2010

EN ISO 21969:2006

Note 2.1

31/05/2010

CEN EN ISO 21987:2009

Ophthalmic optics – Mounted spectacle lenses (ISO 21987:2009)

07/07/2010

CEN EN ISO 22442-1:2007

Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management (ISO 22442-1:2007)

27/02/2008

EN 12442-1:2000

Note 2.1

30/06/2008

CEN EN ISO 22442-2:2007

Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)

27/02/2008

EN 12442-2:2000

Note 2.1

30/06/2008

CEN EN ISO 22442-3:2007

Medical devices utilizing animal tissues and their derivatives – Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)

27/02/2008

EN 12442-3:2000

Note 2.1

30/06/2008

CEN EN ISO 22523:2006

External limb prostheses and external orthoses – Requirements and test methods (ISO 22523:2006)

09/08/2007

EN 12523:1999

Note 2.1

30/04/2007

This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CEN EN ISO 22675:2006

Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods (ISO 22675:2006)

09/08/2007

This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CEN EN ISO 23328-1:2008

Breathing system filters for anaesthetic and respiratory use – Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003)

19/02/2009

EN 13328-1:2001

Note 2.1

30/09/2008

CEN EN ISO 23328-2:2009

Breathing system filters for anaesthetic and respiratory use – Part 2: Non-filtration aspects (ISO 23328-2:2002)

02/12/2009

EN ISO 23328-2:2008

Note 2.1

21/03/2010

CEN EN ISO 23747:2009

Anaesthetic and respiratory equipment – Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)

02/12/2009

EN ISO 23747:2007

Note 2.1

21/03/2010

CEN EN ISO 25539-1:2009

Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

02/12/2009

EN 12006-3:1998+A1:2009
EN ISO 25539-1:2008

Note 2.1

21/03/2010

EN ISO 25539-1:2009/AC:2011

 

30/08/2012

CEN EN ISO 25539-2:2009

Cardiovascular implants – Endovascular devices – Part 2: Vascular stents (ISO 25539-2:2008)

02/12/2009

EN 12006-3:1998+A1:2009
EN ISO 25539-2:2008

Note 2.1

21/03/2010

EN ISO 25539-2:2009/AC:2011

 

30/08/2012

CEN EN ISO 26782:2009

Anaesthetic and respiratory equipment – Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)

07/07/2010

EN ISO 26782:2009/AC:2009

 

07/07/2010

CEN EN 27740:1992

Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

18/11/1995

EN 27740:1992/AC:1996

 

02/12/2009

EN 27740:1992/A1:1997

 

10/08/1999

Note 3

31/05/1998

CEN EN ISO 81060-1:2012

Non-invasive sphygmomanometers – Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)

30/08/2012

EN 1060-1:1995+A2:2009
EN 1060-2:1995+A1:2009

Note 2.1

31/05/2015

Cenelec EN 60118-13:2005

Electroacoustics – Hearing aids — Part 13: Electromagnetic compatibility (EMC)

19/01/2006

EN 60118-13:1997

Note 2.1

01/02/2008

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60522:1999

Determination of the permanent filtration of X-ray tube assemblies

14/11/2001

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60580:2000

Medical electrical equipment – Dose area product meters

13/12/2002

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-1:2006

Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

27/11/2008

EN 60601-1:1990# + A13:1996# + A1:1993# + A2:1995
EN 60601-1-1:2001
EN 60601-1-4:1996# + A1:1999

Note 2.1

01/06/2012

EN 60601-1:2006/AC:2010

 

18/01/2011

EN 60601-1:2006/A1:2013
IEC 60601-1:2005/A1:2012

 

16/05/2014

Note 3

31/12/2017

Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006.
The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31/12/2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 93/42/EEC on 31/12/2015. As from 01/01/2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 93/42/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013.
Cenelec EN 60601-1-1:2001

Medical electrical equipment – Part 1-1: General requirements for safety – Collateral standard: Safety requirements for medical electrical systems

14/11/2001

EN 60601-1-1:1993
+ A1:1996

Note 2.1

01/11/2003

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-1-2:2007

Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests

27/11/2008

EN 60601-1-2:2001
+ A1:2006

Note 2.1

01/06/2012

EN 60601-1-2:2007/AC:2010

 

18/01/2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-1-2:2015 (new)

Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

This is the first publication

EN 60601-1-2:2007

Note 2.1

31/12/2018

Cenelec EN 60601-1-3:2008

Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment

27/11/2008

EN 60601-1-3:1994

Note 2.1

01/06/2012

EN 60601-1-3:2008/AC:2010

 

18/01/2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-1-4:1996

Medical electrical equipment – Part 1-4: General requirements for safety – Collateral standard: Programmable electrical medical systems

08/11/1997

EN 60601-1-4:1996/A1:1999
IEC 60601-1-4:1996/A1:1999

 

08/11/1997

Note 3

01/12/2002

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-1-6:2010

Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

18/01/2011

EN 60601-1-6:2007

Note 2.1

01/04/2013

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-1-8:2007

Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

27/11/2008

EN 60601-1-8:2004
+ A1:2006

Note 2.1

01/06/2012

EN 60601-1-8:2007/AC:2010

 

18/01/2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-1-10:2008

Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers

27/11/2008

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-1-11:2010

Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

18/01/2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-1:1998

Medical electrical equipment – Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV

14/11/2001

EN 60601-2-1:1998/A1:2002
IEC 60601-2-1:1998/A1:2002

 

13/12/2002

Note 3

01/06/2005

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-2:2009

Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

07/07/2010

EN 60601-2-2:2007

Note 2.1

01/04/2012

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-3:1993

Medical electrical equipment – Part 2: Particular requirements for the safety of short-wave therapy equipment

18/11/1995

EN 60601-2-3:1993/A1:1998
IEC 60601-2-3:1991/A1:1998

 

18/11/1995

Note 3

01/07/2001

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-4:2003

Medical electrical equipment — Part 2-4: Particular requirements for the safety of cardiac defibrillators

15/10/2003

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-5:2000

Medical electrical equipment – Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment

13/12/2002

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-8:1997

Medical electrical equipment – Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

14/11/2001

EN 60601-2-8:1997/A1:1997
IEC 60601-2-8:1987/A1:1997

 

14/11/2001

Note 3

01/07/1998

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-10:2000

Medical electrical equipment – Part 2-10: Particular requirements for the safety of nerve and muscle stimulators

13/12/2002

EN 60601-2-10:2000/A1:2001
IEC 60601-2-10:1987/A1:2001

 

13/12/2002

Note 3

01/11/2004

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-11:1997

Medical electrical equipment – Part 2-11: Particular requirements for the safety of gamma beam therapy equipment

09/10/1999

EN 60601-2-11:1997/A1:2004
IEC 60601-2-11:1997/A1:2004

 

09/10/1999

Note 3

01/09/2007

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-12:2006

Medical electrical equipment – Part 2-12: Particular requirements for the safety of lung ventilators – Critical care ventilators

22/12/2007

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-13:2006

Medical electrical equipment – Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems

22/12/2007

EN 60601-2-13:2006/A1:2007
IEC 60601-2-13:2003/A1:2006

 

22/12/2007

Note 3

01/03/2010

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-16:1998

Medical electrical equipment – Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment

09/10/1999

EN 60601-2-16:1998/AC:1999

 

18/01/2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-17:2004

Medical electrical equipment – Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment

08/11/2005

EN 60601-2-17:1996
+ A1:1996

Note 2.1

01/03/2007

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-18:1996

Medical electrical equipment – Part 2: Particular requirements for the safety of endoscopic equipment

09/10/1999

EN 60601-2-18:1996/A1:2000
IEC 60601-2-18:1996/A1:2000

 

09/10/1999

Note 3

01/08/2003

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-19:2009

Medical electrical equipment – Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

07/07/2010

EN 60601-2-19:1996
+ A1:1996

Note 2.1

01/04/2012

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-20:2009

Medical electrical equipment – Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

18/01/2011

EN 60601-2-20:1996

Note 2.1

01/09/2012

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-21:2009

Medical electrical equipment – Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

07/07/2010

EN 60601-2-21:1994
+ A1:1996

Note 2.1

01/04/2012

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-22:1996

Medical electrical equipment – Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment

17/05/1997

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-23:2000

Medical electrical equipment – Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment

14/11/2001

EN 60601-2-23:1997

Note 2.1

01/01/2003

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-24:1998

Medical electrical equipment – Part 2-24: Particular requirements for the safety of infusion pumps and controllers

09/10/1999

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-25:1995

Medical electrical equipment – Part 2-25: Particular requirements for the safety of electrocardiographs

17/05/1997

EN 60601-2-25:1995/A1:1999
IEC 60601-2-25:1993/A1:1999

 

13/12/2002

Note 3

01/05/2002

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-26:2003

Medical electrical equipment – Part 2-26: Particular requirements for the safety of electroencephalographs

08/11/2005

EN 60601-2-26:1994

Note 2.1

01/03/2006

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-27:2006

Medical electrical equipment – Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment

26/07/2006

EN 60601-2-27:1994

Note 2.1

01/11/2008

EN 60601-2-27:2006/AC:2006

 

18/01/2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-28:2010

Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

18/01/2011

EN 60601-2-28:1993

Note 2.1

01/04/2013

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-29:2008

Medical electrical equipment – Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators

15/07/2009

EN 60601-2-29:1999

Note 2.1

01/11/2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-30:2000

Medical electrical equipment — Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment

14/11/2001

EN 60601-2-30:1995

Note 2.1

01/02/2003

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-33:2002

Medical electrical equipment — Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

15/10/2003

EN 60601-2-33:1995
+ A11:1997

Note 2.1

01/07/2005

EN 60601-2-33:2002/A1:2005
IEC 60601-2-33:2002/A1:2005

 

27/07/2006

Note 3

01/11/2008

EN 60601-2-33:2002/A2:2008
IEC 60601-2-33:2002/A2:2007

 

27/11/2008

Note 3

01/02/2011

EN 60601-2-33:2002/A2:2008/AC:2008

 

30/08/2012

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-34:2000

Medical electrical equipment – Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment

15/10/2003

EN 60601-2-34:1995

Note 2.1

01/11/2003

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-36:1997

Medical electrical equipment – Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy

09/10/1999

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-37:2008

Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

27/11/2008

EN 60601-2-37:2001
+ A1:2005
+ A2:2005

Note 2.1

01/10/2010

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-39:2008

Medical electrical equipment – Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

27/11/2008

EN 60601-2-39:1999

Note 2.1

01/03/2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-40:1998

Medical electrical equipment – Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment

09/10/1999

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-41:2009

Medical electrical equipment – Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis

18/01/2011

EN 60601-2-41:2000

Note 2.1

01/11/2012

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-43:2010

Medical electrical equipment – Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures

18/01/2011

EN 60601-2-43:2000

Note 2.1

01/06/2013

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-44:2009

Medical electrical equipment – Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

07/07/2010

EN 60601-2-44:2001
+ A1:2003

Note 2.1

01/05/2012

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-45:2001

Medical electrical equipment — Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices

14/11/2001

EN 60601-2-45:1998

Note 2.1

01/07/2004

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-46:1998

Medical electrical equipment — Part 2-46: Particular requirements for the safety of operating tables

14/11/2001

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-47:2001

Medical electrical equipment – Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems

13/12/2002

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-49:2001

Medical electrical equipment – Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment

13/12/2002

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-50:2009

Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

07/07/2010

EN 60601-2-50:2002

Note 2.1

01/05/2012

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-51:2003

Medical electrical equipment – Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

24/06/2004

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-52:2010

Medical electrical equipment – Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)

13/05/2011

EN 1970:2000# + A1:2005
EN 60601-2-38:1996# + A1:2000

Note 2.1

01/06/2012

EN 60601-2-52:2010/AC:2011

 

30/08/2012

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-2-54:2009

Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

18/01/2011

EN 60601-2-7:1998
EN 60601-2-28:1993
EN 60601-2-32:1994

Note 2.1

01/08/2012

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60627:2001

Diagnostic X-ray imaging equipment – Characteristics of general purpose and mammographic anti-scatter grids

13/12/2002

EN 60627:2001/AC:2002

 

18/01/2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60645-1:2001

Electroacoustics – Audiological equipment – Part 1: Pure-tone audiometers

13/12/2002

EN 60645-1:1994

Note 2.1

01/10/2004

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60645-2:1997

Audiometers – Part 2: Equipment for speech audiometry

17/05/1997

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60645-3:2007

Electroacoustics – Audiometric equipment – Part 3: Test signals of short duration

27/11/2008

EN 60645-3:1995

Note 2.1

01/06/2010

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60645-4:1995

Audiometers – Part 4: Equipment for extended high-frequency audiometry

23/08/1996

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 61217:2012

Radiotherapy equipment – Coordinates, movements and scales

30/08/2012

EN 61217:1996
+ A1:2001
+ A2:2008

Note 2.1

11/01/2015

Cenelec EN 61676:2002

Medical electrical equipment – Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology

15/10/2003

EN 61676:2002/A1:2009
IEC 61676:2002/A1:2008

 

07/07/2010

Note 3

01/03/2012

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 62083:2009

Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems

18/01/2011

EN 62083:2001

Note 2.1

01/11/2012

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 62220-1:2004

Medical electrical equipment – Characteristics of digital X-ray imaging devices – Part 1: Determination of the detective quantum efficiency

24/06/2004

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 62220-1-2:2007

Medical electrical equipment – Characteristics of digital X-ray imaging devices – Part 1-2: Determination of the detective quantum efficiency – Detectors used in mammography

27/11/2008

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 62220-1-3:2008

Medical electrical equipment – Characteristics of digital X-ray imaging devices – Part 1-3: Determination of the detective quantum efficiency – Detectors used in dynamic imaging

15/07/2009

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 62304:2006

Medical device software – Software life-cycle processes

27/11/2008

EN 62304:2006/AC:2008

 

18/01/2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 62366:2008

Medical devices – Application of usability engineering to medical devices

27/11/2008

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 80601-2-35:2009

Medical electrical equipment – Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

18/01/2011

EN 60601-2-35:1996

Note 2.1

01/11/2012

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 80601-2-58:2009

Medical electrical equipment – Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

07/07/2010

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 80601-2-59:2009

Medical electrical equipment – Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

18/01/2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

 

(1) ESO: European standardisation organisation:

CEN: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5500811; fax +32 2 5500819 (http://www.cen.eu)

CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5196871; fax +32 2 5196919 (http://www.cenelec.eu)

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel.+33 492 944200; fax +33 493 654716, (http://www.etsi.eu)

 

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 2.1: The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

Note 2.2: The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

Note 2.3: The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.

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 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 or other requirements of the relevant Union legislation.

 

Normativa armonizada Directiva IVD

https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_en

ESO(1)

Reference and title of the standard
(and reference document)

First publication OJ

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard
Note 1

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

31/07/2002

EN 556:1994 + A1:1998

Note 2.1

30/04/2002

EN 556-1:2001/AC:2006

 

15/11/2006

CEN EN 556-2:2015

Sterilization of medical devices – Requirements for medical devices to be designated ”STERILE” – Part 2: Requirements for aseptically processed medical devices

13/05/2016

EN 556-2:2003

Note 2.1

30/06/2016

CEN EN 980:2008

Symbols for use in the labelling of medical devices

23/07/2008

31/05/2010

CEN EN ISO 11137-2:2015 (new)

Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

This is the first publication

30/06/2016

CEN EN ISO 11737-2:2009

Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

07/07/2010

CEN EN 12322:1999

In vitro diagnostic medical devices – Culture media for microbiology – Performance criteria for culture media

09/10/1999

EN 12322:1999/A1:2001

 

31/07/2002

Note 3

30/04/2002

CEN EN ISO 13408-2:2011

Aseptic processing of health care products – Part 2: Filtration (ISO 13408-2:2003)

19/08/2011

CEN EN ISO 13408-3:2011

Aseptic processing of health care products – Part 3: Lyophilization (ISO 13408-3:2006)

19/08/2011

CEN EN ISO 13408-4:2011

Aseptic processing of health care products – Part 4: Clean-in-place technologies (ISO 13408-4:2005)

19/08/2011

CEN EN ISO 13408-5:2011

Aseptic processing of health care products – Part 5: Sterilization in place (ISO 13408-5:2006)

19/08/2011

CEN EN ISO 13408-6:2011

Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2005)

19/08/2011

CEN EN ISO 13408-7:2015 (new)

Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

This is the first publication

CEN EN ISO 13485:2012

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

30/08/2012

31/08/2012

CEN EN 13532:2002

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

17/12/2002

CEN EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices

17/12/2002

EN 13612:2002/AC:2002

 

02/12/2009

CEN EN 13641:2002

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

17/12/2002

CEN EN 13975:2003

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

21/11/2003

CEN EN 14136:2004

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

15/11/2006

CEN EN 14254:2004

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

28/04/2005

CEN EN 14820:2004

Single-use containers for human venous blood specimen collection

28/04/2005

CEN EN ISO 14937:2009

Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

07/07/2010

EN ISO 14937:2000

Note 2.1

30/04/2010

CEN EN ISO 14971:2012

Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

30/08/2012

EN ISO 14971:2009

Note 2.1

30/08/2012

CEN EN ISO 15193:2009

In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)

07/07/2010

CEN EN ISO 15194:2009

In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)

07/07/2010

CEN EN ISO 15197:2015

In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)

13/05/2016

EN ISO 15197:2003

Note 2.1

31/07/2016

For blood glucose test strips and control solutions, the date of cessation of presumption of conformity of the superseded standard shall be 30/06/2017.
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)

28/04/2005

CEN EN ISO 18113-1:2011

In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

27/04/2012

EN ISO 18113-1:2009

Note 2.1

30/04/2012

CEN EN ISO 18113-2:2011

In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

27/04/2012

EN ISO 18113-2:2009

Note 2.1

30/04/2012

CEN EN ISO 18113-3:2011

In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

27/04/2012

EN ISO 18113-3:2009

Note 2.1

30/04/2012

CEN EN ISO 18113-4:2011

In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

27/04/2012

EN ISO 18113-4:2009

Note 2.1

30/04/2012

CEN EN ISO 18113-5:2011

In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

27/04/2012

EN ISO 18113-5:2009

Note 2.1

30/04/2012

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)

21/11/2003

CEN EN ISO 20776-1:2006

Clinical laboratory testing and in vitro diagnostic test systems – Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices – Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)

09/08/2007

CEN EN ISO 23640:2015

In vitro diagnostic medical devices – Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

13/05/2016

EN ISO 13640:2002

Note 2.1

30/06/2017

Cenelec EN 61010-2-101:2002

Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

17/12/2002

Cenelec EN 61326-2-6:2006

Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment

27/11/2008

Cenelec EN 62304:2006

Medical device software – Software life-cycle processes

27/11/2008

Cenelec EN 62366:2008

Medical devices – Application of usability engineering to medical devices

27/11/2008

 

(1) ESO: European standardisation organisation:

CEN: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5500811; fax +32 2 5500819 (http://www.cen.eu)

CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5196871; fax +32 2 5196919 (http://www.cenelec.eu)

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel.+33 492 944200; fax +33 493 654716, (http://www.etsi.eu)

 

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 2.1: The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

Note 2.2: The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

Note 2.3: The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.

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 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 or other requirements of the relevant Union legislation.

Normativa armonizada Implantables Activos

https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/implantable-medical-devices_en 

ESO(1)

Reference and title of the standard
(and reference document)

First publication OJ

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard
Note 1

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

31/07/2002

EN 556:1994 + A1:1998

Note 2.1

30/04/2002

EN 556-1:2001/AC:2006

 

15/11/2006

CEN EN 556-2:2015 (new)

Sterilization of medical devices – Requirements for medical devices to be designated ”STERILE” – Part 2: Requirements for aseptically processed medical devices

This is the first publication

EN 556-2:2003

Note 2.1

30/06/2016

CEN EN 980:2008

Symbols for use in the labelling of medical devices

23/07/2008

EN 980:2003

Note 2.1

31/05/2010

CEN EN 1041:2008

Information supplied by the manufacturer of medical devices

19/02/2009

EN 1041:1998

Note 2.1

31/08/2011

CEN EN ISO 10993-1:2009

Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

02/12/2009

EN ISO 10993-1:2009

Note 2.1

21/03/2010

EN ISO 10993-1:2009/AC:2010

 

18/01/2011

CEN EN ISO 10993-3:2014

Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

10/07/2015

CEN EN ISO 10993-4:2009

Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)

02/12/2009

EN ISO 10993-4:2002

Note 2.1

21/03/2010

CEN EN ISO 10993-5:2009

Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

02/12/2009

EN ISO 10993-5:1999

Note 2.1

31/12/2009

CEN EN ISO 10993-6:2009

Biological evaluation of medical devices – Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

02/12/2009

EN ISO 10993-6:2007

Note 2.1

21/03/2010

CEN EN ISO 10993-7:2008

Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

07/07/2010

EN ISO 10993-7:2008/AC:2009

 

07/07/2010

CEN EN ISO 10993-9:2009

Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

02/12/2009

EN ISO 10993-9:2009

Note 2.1

21/03/2010

CEN EN ISO 10993-11:2009

Biological evaluation of medical devices – Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

02/12/2009

EN ISO 10993-11:2006

Note 2.1

21/03/2010

CEN EN ISO 10993-12:2012

Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

24/01/2013

EN ISO 10993-12:2009

Note 2.1

31/01/2013

CEN EN ISO 10993-13:2010

Biological evaluation of medical devices – Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

18/01/2011

EN ISO 10993-13:2009

Note 2.1

31/12/2010

CEN EN ISO 10993-16:2010

Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

07/07/2010

EN ISO 10993-16:2009

Note 2.1

31/08/2010

CEN EN ISO 10993-17:2009

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

02/12/2009

EN ISO 10993-17:2002

Note 2.1

21/03/2010

CEN EN ISO 10993-18:2009

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

02/12/2009

EN ISO 10993-18:2005

Note 2.1

21/03/2010

CEN EN ISO 11135-1:2007

Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)

09/08/2007

EN 550:1994

Note 2.1

31/05/2010

CEN EN ISO 11137-1:2015 (new)

Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

This is the first publication

EN ISO 11137-1:2006

Note 2.1

30/06/2016

CEN EN ISO 11137-2:2015 (new)

Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

This is the first publication

EN ISO 11137-2:2013

Note 2.1

30/06/2016

CEN EN ISO 11138-2:2009

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

02/12/2009

EN ISO 11138-2:2006

Note 2.1

21/03/2010

CEN EN ISO 11138-3:2009

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

02/12/2009

EN ISO 11138-3:2006

Note 2.1

21/03/2010

CEN EN ISO 11140-1:2009

Sterilization of health care products – Chemical indicators – Part 1: General requirements (ISO 11140-1:2005)

02/12/2009

EN ISO 11140-1:2005

Note 2.1

21/03/2010

CEN EN ISO 11607-1:2009

Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

02/12/2009

EN ISO 11607-1:2006

Note 2.1

21/03/2010

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)

07/09/2006

EN 1174-1:1996
EN 1174-2:1996
EN 1174-3:1996

Note 2.1

31/10/2006

EN ISO 11737-1:2006/AC:2009

 

02/12/2009

CEN EN ISO 11737-2:2009

Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

07/07/2010

CEN EN ISO 13408-1:2015 (new)

Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

This is the first publication

EN ISO 13408-1:2011

Note 2.1

30/06/2016

CEN EN ISO 13408-2:2011

Aseptic processing of health care products – Part 2: Filtration (ISO 13408-2:2003)

19/08/2011

EN 13824:2004

Note 2.1

31/12/2011

CEN EN ISO 13408-3:2011

Aseptic processing of health care products – Part 3: Lyophilization (ISO 13408-3:2006)

19/08/2011

EN 13824:2004

Note 2.1

31/12/2011

CEN EN ISO 13408-4:2011

Aseptic processing of health care products – Part 4: Clean-in-place technologies (ISO 13408-4:2005)

19/08/2011

EN 13824:2004

Note 2.1

31/12/2011

CEN EN ISO 13408-5:2011

Aseptic processing of health care products – Part 5: Sterilization in place (ISO 13408-5:2006)

19/08/2011

EN 13824:2004

Note 2.1

31/12/2011

CEN EN ISO 13408-6:2011

Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2005)

19/08/2011

EN 13824:2004

Note 2.1

31/12/2011

CEN EN ISO 13408-7:2015 (new)

Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

This is the first publication

CEN EN ISO 13485:2012

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

30/08/2012

EN ISO 13485:2003

Note 2.1

30/08/2012

EN ISO 13485:2012/AC:2012

 

30/08/2012

CEN EN ISO 14155:2011

Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2011)

27/04/2012

EN ISO 14155:2011

Note 2.1

30/04/2012

CEN EN ISO 14937:2009

Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

07/07/2010

EN ISO 14937:2000

Note 2.1

21/03/2010

CEN EN ISO 14971:2012

Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

30/08/2012

EN ISO 14971:2009

Note 2.1

30/08/2012

CEN EN ISO 17665-1:2006

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

15/11/2006

EN 554:1994

Note 2.1

31/08/2009

Cenelec EN 45502-1:1997

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

27/08/1998

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 45502-2-1:2003

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

08/07/2004

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 45502-2-2:2008

Active implantable medical devices – Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)

27/11/2008

EN 45502-2-2:2008/AC:2009

 

18/01/2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 45502-2-3:2010

Active implantable medical devices – Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

18/01/2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 60601-1:2006

Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

27/11/2008

EN 60601-1:1990
+ A13:1996
+ A1:1993
+ A2:1995

Note 2.1

01/06/2012

EN 60601-1:2006/AC:2010

 

18/01/2011

EN 60601-1:2006/A1:2013
IEC 60601-1:2005/A1:2012

 

10/07/2015

Note 3

31/12/2017

Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006.
The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31/12/2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 90/385/EEC on 31/12/2015. As from 01/01/2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 90/385/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013.
Cenelec EN 60601-1-6:2010

Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

18/01/2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 62304:2006

Medical device software – Software life-cycle processes

27/11/2008

EN 62304:2006/AC:2008

 

18/01/2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

 

(1) ESO: European standardisation organisation:

CEN: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5500811; fax +32 2 5500819 (http://www.cen.eu)

CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5196871; fax +32 2 5196919 (http://www.cenelec.eu)

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel.+33 492 944200; fax +33 493 654716, (http://www.etsi.eu)

 

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 2.1: The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

Note 2.2: The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

Note 2.3: The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.

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 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 or other requirements of the relevant Union legislation.

 

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