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医疗器械欧盟CE认证协调标准清单

MDDXIEDIAOBIAOZHUNQINGDAN

ESO

Reference and title of the harmonised standard 
(and reference document)

First publication OJ

皇冠篮球比分网Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard

CEN

EN 285:2006+A2:2009 
皇冠篮球比分网Sterilization - Steam sterilizers - Large sterilizers

02/12/2009 

EN 285:2006+A1:2008

Date expired
(21/03/2010) 

CEN

EN 455-1:2000 
皇冠篮球比分网Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

30/09/2005 

EN 455-1:1993

Date expired
(30/04/2001) 

CEN

EN 455-3:2006 
皇冠篮球比分网Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

09/08/2007 

EN 455-3:1999
 

Date expired
皇冠篮球比分网(30/06/2007) 

CEN

EN 455-4:2009 
皇冠篮球比分网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

Date expired
皇冠篮球比分网(30/04/2002) 

皇冠篮球比分网EN 556-1:2001/AC:2006

皇冠篮球比分网15/11/2006 

CEN

EN 556-2:2003 
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

09/08/2007 

CEN

EN 794-3:1998+A2:2009 
皇冠篮球比分网Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators

07/07/2010 

EN 794-3:1998

Date expired
(21/03/2010) 

CEN

EN 1041:2008 
Information supplied by the manufacturer of medical devices

19/02/2009 

EN 1041:1998

Date expired
皇冠篮球比分网(31/08/2011) 

CEN

EN 1060-3:1997+A2:2009 
皇冠篮球比分网Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

07/07/2010 

EN 1060-3:1997

Date expired
(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 1282-2:2005+A1:2009 
皇冠篮球比分网Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)

07/07/2010 

EN 1282-2:2005

Date expired
皇冠篮球比分网(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

Date expired
皇冠篮球比分网(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

皇冠篮球比分网07/07/2010 

EN 1639:2004

Date expired
皇冠篮球比分网(30/04/2010) 

CEN

EN 1640:2009 
皇冠篮球比分网Dentistry - Medical devices for dentistry - Equipment

07/07/2010 

EN 1640:2004

Date expired
(30/04/2010) 

CEN

EN 1641:2009 
皇冠篮球比分网Dentistry - Medical devices for dentistry - Materials

07/07/2010 

EN 1641:2004

Date expired
(30/04/2010) 

CEN

EN 1642:2011 
Dentistry - Medical devices for dentistry - Dental implants

27/04/2012 

EN 1642:2009

Date expired
皇冠篮球比分网(30/04/2012) 

CEN

EN 1707:1996 
皇冠篮球比分网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 
皇冠篮球比分网Tracheal tubes and connectors

07/07/2010 

EN 1782:1998

Date expired
皇冠篮球比分网(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 
皇冠篮球比分网Anaesthetic reservoir bags (ISO 5362:2000, modified)

07/07/2010 

EN 1820:2005

Date expired
皇冠篮球比分网(21/03/2010) 

CEN

EN 1865-3:2012 
皇冠篮球比分网Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher

皇冠篮球比分网30/08/2012 

EN 1865:1999

皇冠篮球比分网31/12/2012 

CEN

EN 1865-4:2012 
皇冠篮球比分网Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair

皇冠篮球比分网30/08/2012 

EN 1865:1999

Date expired
(31/10/2012) 

CEN

EN 1865-5:2012 
Patient handling equipment used in road ambulances - Part 5: Stretcher support

皇冠篮球比分网30/08/2012 

EN 1865:1999

皇冠篮球比分网31/12/2012 

CEN

EN 1985:1998 
皇冠篮球比分网Walking aids - General requirements and test methods

皇冠篮球比分网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)

皇冠篮球比分网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 4074:2002 
Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002)

皇冠篮球比分网31/07/2002 

EN 600:1996

Date expired
(31/08/2005) 

皇冠篮球比分网EN ISO 4074:2002/AC:2008

02/12/2009 

CEN

EN ISO 4135:2001 
Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)

31/07/2002 

EN ISO 4135:1996

Date expired
(28/02/2002) 

CEN

EN ISO 5356-1:2004 
皇冠篮球比分网Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2004)

皇冠篮球比分网30/09/2005 

EN 1281-1:1997

Date expired
皇冠篮球比分网(30/11/2004) 

CEN

EN ISO 5356-2:2007 
Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2006)

09/11/2007 

EN 1281-2:1995

Date expired
(29/02/2008) 

CEN

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

23/07/2008 

EN 739:1998

Date expired
皇冠篮球比分网(30/06/2010) 

EN ISO 5359:2008/A1:2011

皇冠篮球比分网30/08/2012 

Date expired
皇冠篮球比分网(30/06/2012) 

CEN

EN ISO 5360:2009 
Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)

皇冠篮球比分网02/12/2009 

EN ISO 5360:2007

Date expired
(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

Date expired
皇冠篮球比分网(21/03/2010) 

CEN

EN ISO 5840:2009 
皇冠篮球比分网Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

02/12/2009 

EN ISO 5840:2005

Date expired
皇冠篮球比分网(21/03/2010) 

CEN

EN ISO 7197:2009 
Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)

皇冠篮球比分网02/12/2009 

EN ISO 7197:2006

Date expired
皇冠篮球比分网(21/03/2010) 

CEN

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

皇冠篮球比分网02/12/2009 

EN ISO 7376:2009

Date expired
皇冠篮球比分网(21/03/2010) 

CEN

EN ISO 7396-1:2007 
皇冠篮球比分网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

Date expired
皇冠篮球比分网(30/04/2009) 

EN ISO 7396-1:2007/A1:2010

皇冠篮球比分网07/07/2010 

Date expired
皇冠篮球比分网(31/07/2010) 

EN ISO 7396-1:2007/A2:2010

07/07/2010 

Date expired
(31/08/2010) 

CEN

EN ISO 7396-2:2007 
皇冠篮球比分网Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)

09/08/2007 

EN 737-2:1998

Date expired
(30/04/2009) 

CEN

EN ISO 7886-3:2009 
皇冠篮球比分网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

Date expired
皇冠篮球比分网(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)

皇冠篮球比分网07/07/2010 

EN ISO 7886-4:2006

Date expired
皇冠篮球比分网(21/03/2010) 


MDDXIEDIAOBIAOZHUNQINGDAN(2)

CEN

EN ISO 8185:2009 
皇冠篮球比分网Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)

皇冠篮球比分网02/12/2009 

EN ISO 8185:2007

Date expired
(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

Date expired
皇冠篮球比分网(21/03/2010) 

CEN

EN ISO 8835-2:2009 
Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)

皇冠篮球比分网02/12/2009 

EN ISO 8835-2:2007

Date expired
皇冠篮球比分网(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)

皇冠篮球比分网02/12/2009 

EN ISO 8835-3:2007

Date expired
皇冠篮球比分网(21/03/2010) 

EN ISO 8835-3:2009/A1:2010

皇冠篮球比分网13/05/2011 

Date expired
(30/04/2011) 

CEN

EN ISO 8835-4:2009 
Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)

皇冠篮球比分网02/12/2009 

EN ISO 8835-4:2004

Date expired
(21/03/2010) 

CEN

EN ISO 8835-5:2009 
皇冠篮球比分网Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)

02/12/2009 

EN ISO 8835-5:2004

Date expired
皇冠篮球比分网(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)

皇冠篮球比分网19/02/2009 

EN 737-1:1998

Date expired
(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

Date expired
(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)

皇冠篮球比分网02/12/2009 

EN ISO 9360-1:2000

Date expired
(21/03/2010) 

CEN

EN ISO 9360-2:2009 
皇冠篮球比分网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)

皇冠篮球比分网02/12/2009 

EN ISO 9360-2:2002

Date expired
(21/03/2010) 

CEN

EN ISO 9713:2009 
皇冠篮球比分网Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)

皇冠篮球比分网02/12/2009 

EN ISO 9713:2004

Date expired
(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

Date expired
(21/03/2010) 

CEN

EN ISO 10079-2:2009 
皇冠篮球比分网Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)

02/12/2009 

EN ISO 10079-2:1999

Date expired
皇冠篮球比分网(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)

皇冠篮球比分网02/12/2009 

EN ISO 10079-3:1999

Date expired
(21/03/2010) 

CEN

EN ISO 10328:2006 
皇冠篮球比分网Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006)

09/08/2007 

皇冠篮球比分网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)

皇冠篮球比分网02/06/2006 

EN 738-1:1997

Date expired
皇冠篮球比分网(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

Date expired
皇冠篮球比分网(31/10/2008) 

CEN

EN ISO 10524-3:2006 
皇冠篮球比分网Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)

皇冠篮球比分网07/09/2006 

EN 738-3:1998

Date expired
(31/10/2008) 

CEN

EN ISO 10524-4:2008 
皇冠篮球比分网Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

23/07/2008 

EN 738-4:1998

Date expired
皇冠篮球比分网(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

Date expired
皇冠篮球比分网(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

Date expired
皇冠篮球比分网(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)

皇冠篮球比分网02/12/2009 

EN ISO 10651-2:2004

Date expired
皇冠篮球比分网(21/03/2010) 

CEN

EN ISO 10651-4:2009 
Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)

皇冠篮球比分网02/12/2009 

EN ISO 10651-4:2002

Date expired
皇冠篮球比分网(21/03/2010) 

CEN

EN ISO 10651-6:2009 
皇冠篮球比分网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

Date expired
(21/03/2010) 

CEN

EN ISO 10993-1:2009 
皇冠篮球比分网Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

皇冠篮球比分网02/12/2009 

EN ISO 10993-1:2009

Date expired
(21/03/2010) 

皇冠篮球比分网EN ISO 10993-1:2009/AC:2010

18/01/2011 

CEN

EN ISO 10993-3:2009 
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)

02/12/2009 

EN ISO 10993-3:2003

Date expired
(21/03/2010) 

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)

皇冠篮球比分网02/12/2009 

EN ISO 10993-4:2002

Date expired
(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

Date expired
(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

Date expired
皇冠篮球比分网(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

皇冠篮球比分网07/07/2010 

CEN

EN ISO 10993-9:2009 
皇冠篮球比分网Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

皇冠篮球比分网02/12/2009 

EN ISO 10993-9:2009

Date expired
(21/03/2010) 

CEN

EN ISO 10993-11:2009 
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

皇冠篮球比分网02/12/2009 

EN ISO 10993-11:2006

Date expired
皇冠篮球比分网(21/03/2010) 

CEN

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

 

EN ISO 10993-12:2009

皇冠篮球比分网31/01/2013 

CEN

EN ISO 10993-13:2010 
皇冠篮球比分网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

Date expired
(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

Date expired
皇冠篮球比分网(21/03/2010) 

 

MDDXIEDIAOBIAOZHUNQINGDAN(3)

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)

皇冠篮球比分网02/12/2009 

EN ISO 10993-15:2000

Date expired
皇冠篮球比分网(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)

皇冠篮球比分网07/07/2010 

EN ISO 10993-16:2009

Date expired
皇冠篮球比分网(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

Date expired
(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

Date expired
皇冠篮球比分网(21/03/2010) 

CEN

EN ISO 11135-1:2007 
皇冠篮球比分网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

Date expired
(31/05/2010) 

CEN

EN ISO 11137-1:2006 
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)

07/09/2006 

EN 552:1994

Date expired
(30/04/2009) 

CEN

EN ISO 11137-2:2012 
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)

皇冠篮球比分网30/08/2012 

EN ISO 11137-2:2007

Date expired
(30/09/2012) 

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

Date expired
(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)

皇冠篮球比分网02/12/2009 

EN ISO 11138-3:2006

Date expired
(21/03/2010) 

CEN

EN ISO 11140-1:2009 
皇冠篮球比分网Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

皇冠篮球比分网02/12/2009 

EN ISO 11140-1:2005

Date expired
(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

Date expired
(21/03/2010) 

CEN

EN ISO 11197:2009 
皇冠篮球比分网Medical supply units (ISO 11197:2004)

02/12/2009 

EN ISO 11197:2004

Date expired
皇冠篮球比分网(21/03/2010) 

CEN

EN ISO 11607-1:2009 
皇冠篮球比分网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

Date expired
(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)

皇冠篮球比分网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)

皇冠篮球比分网07/09/2006 

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

Date expired
(31/10/2006) 

EN ISO 11737-1:2006/AC:2009

皇冠篮球比分网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)

皇冠篮球比分网07/07/2010 

CEN

EN ISO 11810-1:2009 
皇冠篮球比分网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 
皇冠篮球比分网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

Date expired
(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

Date expired
(21/03/2010) 

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

Date expired
皇冠篮球比分网(21/03/2010) 

CEN

EN 12183:2009 
Manual wheelchairs - Requirements and test methods

07/07/2010 

CEN

EN 12184:2009 
皇冠篮球比分网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

皇冠篮球比分网07/07/2010 

EN 12342:1998

Date expired
(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

Date expired
(21/03/2010) 

CEN

EN 12470-2:2000+A1:2009 
Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers

皇冠篮球比分网02/12/2009 

EN 12470-2:2000

Date expired
皇冠篮球比分网(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

皇冠篮球比分网02/12/2009 

EN 12470-3:2000

Date expired
皇冠篮球比分网(21/03/2010) 

CEN

EN 12470-4:2000+A1:2009 
皇冠篮球比分网Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement

皇冠篮球比分网02/12/2009 

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