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嘉峪检测网 2015-01-27 22:07
医疗器械指令的协调标准约250多项，详见下表：
|
欧洲标准组织 |
协调标准 |
发布时间 |
被替代标准 |
|
CEN
|
EN 285:2006+A2:2009 Sterilization - Steam sterilizers - Large sterilizers |
02/12/2009
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EN 285:2006+A1:2008 |
|
CEN |
EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes |
30/09/2005
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EN 455-1:1993 |
|
CEN |
EN 455-3:2006 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
09/08/2007
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EN 455-3:1999 |
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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
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31/07/2002
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EN 556:1994 + A1:1998 |
|
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
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CEN |
EN 794-3:1998+A2:2009 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
|
07/07/2010
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EN 794-3:1998 |
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CEN |
EN 1041:2008 Information supplied by the manufacturer of medical devices
|
19/02/2009
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EN 1041:1998 |
|
CEN |
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
|
07/07/2010
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EN 1060-3:1997 |
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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 Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
|
07/07/2010
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EN 1282-2:2005 |
|
CEN |
EN 1422:1997+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
|
02/12/2009
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EN 1422:1997 |
|
CEN |
EN 1618:1997 Catheters other than intravascular catheters - Test methods for common properties
|
09/05/1998
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|
CEN |
EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
|
07/07/2010
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07/07/2010
|
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CEN |
EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
|
07/07/2010
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EN 1640:2004 |
|
CEN |
EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
|
07/07/2010 |
EN 1641:2004 |
|
CEN |
EN 1642:2011 Dentistry - Medical devices for dentistry - Dental implants
|
27/04/2012
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EN 1642:2009 |
|
CEN |
EN 1707:1996 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings
|
17/05/1997
|
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CEN |
EN 1782:1998+A1:2009 Tracheal tubes and connectors
|
07/07/2010
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|
CEN |
EN 1789:2007+A1:2010 Medical vehicles and their equipment - Road ambulances
|
18/01/2011
|
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CEN |
EN 1820:2005+A1:2009 Anaesthetic reservoir bags (ISO 5362:2000, modified)
|
07/07/2010
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EN 1820:2005 |
|
CEN |
EN 1865-3:2012 Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher
|
30/08/2012
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EN 1865:1999 |
|
CEN |
EN 1865-4:2012 Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair
|
30/08/2012
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EN 1865:1999 |
|
CEN |
EN 1865-5:2012 Patient handling equipment used in road ambulances - Part 5: Stretcher support
|
30/08/2012
|
EN 1865:1999 |
|
CEN |
EN 1985:1998 Walking aids - General requirements and test methods
|
10/08/1999
|
|
|
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
|
|
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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)
|
31/07/2002
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EN 600:1996 |
|
CEN |
EN ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)
|
31/07/2002
|
|
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CEN |
EN ISO 5356-1:2004 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2004)
|
30/09/2005
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EN 1281-1:1997 |
|
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
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EN 1281-2:1995 |
|
CEN |
EN ISO 5359:2008 Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)
|
23/07/2008
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EN 739:1998 |
|
CEN |
EN ISO 5360:2009 Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)
|
02/12/2009
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EN ISO 5360:2007 |
|
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 |
|
CEN |
EN ISO 5840:2009 Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)
|
02/12/2009
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EN ISO 5840:2005 |
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CEN |
EN ISO 7197:2009 Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)
|
02/12/2009
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EN ISO 7197:2006 |
|
CEN |
EN ISO 7376:2009 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)
|
02/12/2009
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EN ISO 7376:2009 |
|
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
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EN 737-3:1998 |
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CEN |
EN ISO 7396-2:2007 Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)
|
09/08/2007
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EN 737-2:1998 |
|
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
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EN ISO 7886-3:2005 |
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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
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EN ISO 7886-4:2006 |
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CEN |
EN ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
|
02/12/2009
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EN ISO 8185:2007 |
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CEN |
EN ISO 8359:2009 Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)
|
02/12/2009
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EN ISO 8359:1996 |
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CEN |
EN ISO 8835-2:2009 Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)
|
02/12/2009
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EN ISO 8835-2:2007 |
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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
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EN ISO 8835-3:2007 |
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CEN |
EN ISO 8835-4:2009 Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
|
02/12/2009
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EN ISO 8835-4:2004 |
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CEN |
EN ISO 8835-5:2009 Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)
|
02/12/2009
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EN ISO 8835-5:2004 |
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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
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EN 737-1:1998 |
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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
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EN 737-4:1998 |
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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
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EN ISO 9360-1:2000 |
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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
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EN ISO 9360-2:2002 |
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CEN |
EN ISO 9713:2009 Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)
|
02/12/2009
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EN ISO 9713:2004 |
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CEN |
EN ISO 10079-1:2009 Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)
|
02/12/2009
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EN ISO 10079-1:1999 |
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CEN |
EN ISO 10079-2:2009 Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)
|
02/12/2009
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EN ISO 10079-3:1999 |
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CEN |
EN ISO 10328:2006 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006)
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09/08/2007
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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)
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02/06/2006
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EN 738-1:1997 |
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CEN |
EN ISO 10524-2:2006 Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)
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07/06/2009
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EN 738-2:1998 |
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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)
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07/09/2006
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EN 738-3:1998 |
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CEN |
EN ISO 10524-4:2008 Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)
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23/07/2008
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EN 738-4:1998 |
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CEN |
EN ISO 10535:2006 Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)
|
09/08/2007
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EN ISO 10535:1998
|
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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
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EN ISO 10555-1:1996 |
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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
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EN ISO 10651-2:2004 |
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CEN |
EN ISO 10651-4:2009 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
|
02/12/2009
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EN ISO 10651-4:2002 |
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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
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EN ISO 10651-6:2004 |
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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
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EN ISO 10993-1:2009 |
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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
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EN ISO 10993-3:2003 |
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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
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EN ISO 10993-4:2002 |
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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
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EN ISO 10993-5:1999 |
|
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
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EN ISO 10993-6:2007 |
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CEN |
EN ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
|
19/02/2009
|
|
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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 10993-9:2009 |
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CEN |
EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
|
02/12/2009
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EN ISO 10993-11:2006 |
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CEN |
EN ISO 10993-12:2012 (new) Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
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EN ISO 10993-12:2009 |
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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)
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18/01/2011
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EN ISO 10993-13:2009 |
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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)
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02/12/2009
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EN ISO 10993-14:2001 |
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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
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EN ISO 10993-15:2000 |
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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)
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07/07/2010
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EN ISO 10993-16:2009 |
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CEN |
EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
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02/12/2009
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EN ISO 10993-17:2002 |
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CEN |
EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
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02/12/2009
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EN ISO 10993-18:2005 |
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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
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EN 550:1994 |
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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
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EN 552:1994 |
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CEN |
EN ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
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30/08/2012
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EN ISO 11137-2:2007 |
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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)
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02/12/2009
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EN ISO 11138-2:2006 |
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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)
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02/12/2009
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EN ISO 11138-3:2006 |
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CEN |
EN ISO 11140-1:2009 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)
|
02/12/2009
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EN ISO 11140-1:2005 |
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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
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EN ISO 11140-3:2007 |
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CEN |
EN ISO 11197:2009 Medical supply units (ISO 11197:2004)
|
02/12/2009
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EN ISO 11197:2004 |
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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)
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07/09/2006
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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)
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07/09/2006
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EN 1174-2:1996 |
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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)
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07/07/2010
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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)
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02/12/2009 |
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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
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EN ISO 11810-2:2007 |
|
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 |
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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
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EN 12006-2:1998 |
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CEN |
EN 12183:2009 Manual wheelchairs - Requirements and test methods
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07/07/2010
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CEN |
EN 12184:2009 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
|
07/07/2010
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CEN |
EN 12342:1998+A1:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators
|
07/07/2010
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EN 12342:1998 |
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CEN |
EN 12470-1:2000+A1:2009 Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
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02/12/2009
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EN 12470-1:2000 |
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CEN |
EN 12470-2:2000+A1:2009 Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
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02/12/2009
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EN 12470-2:2000 |
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CEN |
EN 12470-3:2000+A1:2009 Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
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02/12/2009
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EN 12470-3:2000 |
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CEN |
EN 12470-4:2000+A1:2009 Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement
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02/12/2009
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EN 12470-4:2000 |
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CEN |
EN 12470-5:2003 Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)
|
07/11/2003
|
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CEN |
EN ISO 12870:2009 Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004)
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02/12/2009
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EN ISO 12870:2004 |
|
CEN |
EN 13060:2004+A2:2010 Small steam sterilizers
|
07/07/2010
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EN 13060:2004+A1:2009 |
|
CEN |
EN ISO 13408-1:2011 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)
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19/08/2011
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EN 13824:2004 |
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CEN |
EN ISO 13408-2:2011 Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
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19/08/2011
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EN 13824:2004 |
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CEN |
EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
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19/08/2011
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EN 13824:2004 |
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CEN |
EN ISO 13408-4:2011 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
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19/08/2011
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EN 13824:2004 |
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CEN |
EN ISO 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
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19/08/2011
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EN 13824:2004 |
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CEN |
EN ISO 13408-6:2011 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
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19/08/2011
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EN 13824:2004 |
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CEN |
EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
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30/08/2012
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EN ISO 13485:2003 |
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CEN |
EN 13544-1:2007+A1:2009 Respiratory therapy equipment - Part 1: Nebulizing systems and their components
|
07/07/2010
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EN 13544-1:2007 |
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CEN |
EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors
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07/07/2010
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EN 13544-2:2002 |
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CEN |
EN 13544-3:2001+A1:2009 Respiratory therapy equipment - Part 3: Air entrainment devices
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07/07/2010
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EN 13544-3:2001 |
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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)
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30/09/2005
|
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CEN |
EN 13718-1:2008 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
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19/02/2009
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EN 13718-1:2002 |
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CEN |
EN 13726-1:2002 Test methods for primary wound dressings - Part 1: Aspects of absorbency
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27/03/2003
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CEN |
EN 13726-2:2002 Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings
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27/03/2003
|
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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)
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30/08/2012
|
EN 13727:2003 |
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CEN |
EN 13867:2002+A1:2009 Concentrates for haemodialysis and related therapies
|
02/12/2009
|
EN 13867:2002 |
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CEN |
EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
|
19/08/2011
|
EN 13976-1:2003 |
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CEN |
EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
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19/08/2011
|
EN 13976-2:2003 |
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CEN |
EN 14079:2003 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
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30/09/2005
|
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CEN |
EN 14139:2010 Ophthalmic optics - Specifications for ready-to-wear spectacles
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18/01/2011
|
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CEN |
EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
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27/04/2012
|
EN ISO 14155:2011 |
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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 |
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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)
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30/09/2005
|
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CEN |
EN ISO 14408:2009 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)
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02/12/2009
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EN ISO 14408:2005 |
|
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
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|
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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
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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 |
|
CEN |
EN ISO 14607:2009 Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)
|
02/12/2009
|
EN ISO 14607:2007 |
|
CEN |
EN ISO 14630:2009 Non-active surgical implants - General requirements (ISO 14630:2008)
|
02/12/2009
|
EN ISO 14630:2008 |
|
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 |
|
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
|
|
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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 |
|
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 |
|
CEN |
EN ISO 15001:2011 Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
|
27/04/2012
|
EN ISO 15001:2010 |
|
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 |
|
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 |
|
CEN |
EN ISO 15747:2011 Plastic containers for intravenous injections (ISO 15747:2010)
|
27/04/2012
|
EN ISO 15747:2010 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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
|
|
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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 |
|
CEN |
EN ISO 18777:2009 Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)
|
02/12/2009
|
EN ISO 18777:2005 |
|
CEN |
EN ISO 18778:2009 Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
|
02/12/2009
|
EN ISO 18778:2005 |
|
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 |
|
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
|
|
|
CEN |
EN ISO 21171:2006 Medical gloves - Determination of removable surface powder (ISO 21171:2006)
|
07/09/2006
|
|
|
CEN |
EN ISO 21534:2009 Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)
|
02/12/2009
|
|
|
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 |
|
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 |
|
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 |
|
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 |
|
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
|
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|
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
|
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|
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 |
|
CEN |
EN ISO 22523:2006 External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
|
09/08/2007
|
EN 12523:1999 |
|
CEN |
EN ISO 22610:2006 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006)
|
15/11/2006
|
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|
CEN |
EN ISO 22612:2005 Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)
|
30/09/2005
|
|
|
CEN |
EN ISO 22675:2006 Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2006)
|
09/08/2007
|
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|
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 |
|
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 |
|
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 |
|
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 ISO 25539-1:2008 |
|
CEN |
EN ISO 25539-2:2009 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
|
02/12/2009
|
EN ISO 25539-2:2008 |
|
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
|
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|
CEN |
EN 27740:1992 Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)
|
18/11/1995
|
|
|
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 1060-2:1995+A1:2009 |
|
Cenelec
|
EN 60118-13:2005
Electroacoustics - Hearing aids -- Part 13: Electromagnetic compatibility (EMC)
|
19/01/2006
|
EN 60118-13:1997 |
|
|
EN 60522:1999
Determination of the permanent filtration of X-ray tube assemblies
|
14/11/2001
|
|
|
|
EN 60580:2000
Medical electrical equipment - Dose area product meters
|
13/12/2002
|
|
|
|
EN 60601-1:2006
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
|
27/11/2008
|
EN 60601-1:1990 |
|
|
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 |
|
|
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 |
|
|
EN 60601-1-6:2007
Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
|
27/11/2008
|
EN 60601-1-6:2004 |
|
|
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 |
|
|
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 |
|
|
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
|
|
|
|
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
|
|
|
|
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
|
|
|
|
EN60601-2-1:1998/A1:2002
|
13/12/2002
|
|
|
|
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 |
|
|
EN 60601-2-3:1993
Medical electrical equipment -- Part 2: Particular requirements for the safety of short-wave therapy equipment
|
18/11/1995
|
|
|
|
EN 60601-2-4:2003
Medical electrical equipment -- Part 2-4: Particular requirements for the safety of cardiac defibrillators
|
15/10/2003
|
|
|
|
EN 60601-2-5:2000
Medical electrical equipment -- Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
|
13/12/2002
|
|
|
|
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 60601-2-10:2000
Medical electrical equipment -- Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
|
13/12/2002
|
|
|
|
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 60601-2-12:2006
Medical electrical equipment -- Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
|
22/12/2007
|
|
|
|
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 60601-2-16:1998
Medical electrical equipment -- Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
|
09/10/1999
|
|
|
|
EN 60601-2-17:2004
Medical electrical equipment -- Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
|
08/11/2005
|
|
|
|
EN 60601-2-18:1996
Medical electrical equipment -- Part 2: Particular requirements for the safety of endoscopic equipment
|
09/10/1999
|
|
|
|
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
|
|
|
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 |
|
|
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
|
|
|
EN 60601-2-22:1996
Medical electrical equipment -- Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
|
17/05/1997
|
|
|
|
EN 60601-2-24:1998
Medical electrical equipment -- Part 2-24: Particular requirements for the safety of infusion pumps and controllers
|
09/10/1999
|
|
|
|
EN 60601-2-25:1995
Medical electrical equipment -- Part 2-25: Particular requirements for the safety of electrocardiographs
|
17/05/1997
|
|
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|
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 |
|
|
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 |
|
|
EN 60601-2-28:1993
Medical electrical equipment -- Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
|
18/11/1995
|
|
|
|
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 |
|
|
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 |
|
|
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 |
|
|
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 |
|
|
EN 60601-2-33:2002/A1:2005
|
27/07/2006
|
|
|
|
EN 60601-2-33:2002/A2:2008
|
27/11/2008
|
|
|
|
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 60601-2-35:1996
Medical electrical equipment -- Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use
|
09/10/1999
|
|
|
|
EN 60601-2-36:1997
Medical electrical equipment -- Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
|
09/10/1999
|
|
|
|
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 |
|
|
EN 60601-2-38:1996
Medical electrical equipment -- Part 2-38: Particular requirements for the safety of electrically operated hospital beds
|
09/10/1999
|
|
|
|
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 |
|
|
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
|
|
|
|
EN 60601-2-41:2000
Medical electrical equipment -- Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis
|
14/11/2001
|
|
|
|
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 |
|
|
EN 60601-2-43:2000
Medical electrical equipment -- Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures
|
13/12/2002
|
|
|
|
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
|
|
|
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 |
|
|
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 |
|
|
EN 60601-2-46:1998
Medical electrical equipment -- Part 2-46: Particular requirements for the safety of operating tables
|
14/11/2001
|
|
|
|
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
|
|
|
|
EN 60601-2-49:2001
Medical electrical equipment -- Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment
|
13/12/2002
|
|
|
|
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 |
|
|
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
|
|
|
|
EN 60601-2-52:2010
Medical electrical equipment -- Part 2-52: Particular requirements for basic safety and essential performance of medical beds
|
13/05/2011
|
EN 60601-2-38:1996 |
|
|
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 60627:2001
Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
|
13/12/2002
|
|
|
|
EN 60645-1:2001
Electroacoustics - Audiological equipment -- Part 1: Pure-tone audiometers
|
13/12/2002
|
EN 60645-1:1994 |
|
|
EN 60645-2:1997
Audiometers -- Part 2: Equipment for speech audiometry
|
17/05/1997
|
|
|
|
EN 60645-3:2007
Electroacoustics - Audiometric equipment -- Part 3: Test signals of short duration
|
27/11/2008
|
EN 60645-3:1995 |
|
|
EN 60645-4:1995
Audiometers -- Part 4: Equipment for extended high-frequency audiometry
|
23/08/1996
|
|
|
|
EN 61217:1996
Radiotherapy equipment - Coordinates, movements and scales
|
14/11/2001
|
|
|
|
EN 61217:2012
Radiotherapy equipment - Coordinates, movements and scales
|
30/08/2012
|
EN 61217:1996 |
|
|
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 62083:2001
Medical electrical equipment -- Requirements for the safety of radiotherapy treatment planning systems
|
13/12/2002
|
|
|
|
EN 62083:2009
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
|
18/01/2011
|
EN 62083:2001 |
|
|
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
|
|
|
|
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
|
|
|
|
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
|
|
|
|
EN 62304:2006
Medical device software - Software life-cycle processes
|
27/11/2008
|
|
|
|
EN 62366:2008
Medical devices - Application of usability engineering to medical devices
|
27/11/2008
|
|
|
|
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 |
|
|
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
|
|
|
|
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
|
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来源：AnyTesting
