About CEN
The European Committee for Standardization is one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as being responsible for developing and defining voluntary standards at European level.
CEN/TC 205 |
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Non-active medical devices |
CEN/TC 205 Published Standards
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Project reference, Title
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Publication date
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Sales Points
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CEN/TR 15831:2009
(WI=00205193) Method for testing compression in medical hosiery |
2009-04-22 |
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CEN/TR 16953:2017
(WI=00205317) Medical gloves for single use - Guidance for selection |
2017-11-15 |
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EN 12439:1998
(WI=00205069) Sterile rectal catheters for single use |
1998-10-21 |
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EN 12470-1:2000+A1:2009
(WI=00205217) Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device |
2009-06-17 |
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EN 12470-2:2000+A1:2009
(WI=00205218) Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers |
2009-06-17 |
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EN 13726:2023
(WI=00205358) Test methods for wound dressings - Aspects of absorption, moisture vapour transmission, waterproofness and extensibility |
2023-09-20 |
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EN 13795-1:2019
(WI=00205248) Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns |
2019-04-03 |
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EN 13795-2:2019
(WI=00205249) Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits |
2019-04-03 |
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EN 13868:2002
(WI=00205104) Catheters - Test methods for kinking of single lumen catheters and medical tubing |
2002-08-28 |
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EN 14079:2003
(WI=00205144) Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze |
2003-04-23 |
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EN 14683:2019+AC:2019
(WI=00205354) Medical face masks - Requirements and test methods |
2019-08-07 |
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EN 1644-1:1997
(WI=00205093) Test methods for nonwoven compresses for medical use - Part 1: Nonwovens used in the manufacture of compresses |
1997-02-19 |
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EN 1644-2:2000
(WI=00205094) Test methods for nonwoven compresses for medical use - Part 2: Finished compresses |
2000-01-19 |
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EN 17854:2024
(WI=00205320) Antimicrobial wound dressings - Requirements and test method |
2024-03-20 |
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EN 27740:1992
(WI=00205017) Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) |
1992-05-22 |
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EN 27740:1992/A1:1997
(WI=00205117) Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) |
1997-11-19 |
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EN 27740:1992/AC:1996
(WI=00205C04) Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) |
1996-09-18 |
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EN 455-1:2020+A2:2024
(WI=00205407) Medical gloves for single use - Part 1: Requirements and testing for freedom of holes |
2024-09-18 |
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EN 455-2:2024
(WI=00205386) Medical gloves for single use - Part 2: Requirements and testing for physical properties |
2024-05-08 |
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EN 455-3:2023
(WI=00205359) Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
2023-11-29 |
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EN 455-4:2009
(WI=00205173) Medical gloves for single use - Part 4: Requirements and testing for shelf life determination |
2009-07-29 |
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EN ISO 10555-1:2023
(WI=00205366) Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2023) |
2023-11-29 |
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EN ISO 10555-3:2013
(WI=00205236) Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013) |
2013-07-10 |
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EN ISO 10555-4:2023
(WI=00205367) Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2023) |
2023-11-29 |
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EN ISO 10555-5:2013
(WI=00205238) Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters (ISO 10555-5:2013) |
2013-07-10 |
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EN ISO 10555-6:2017
(WI=00205318) Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015) |
2017-08-23 |
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EN ISO 10555-6:2017/A1:2019
(WI=00205351) Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports - Amendment 1 (ISO 10555-6:2015/Amd 1:2019) |
2019-10-23 |
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EN ISO 11070:2014
(WI=00205260) Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014) |
2014-11-12 |
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EN ISO 11070:2014/A1:2018
(WI=00205334) Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:2018) |
2018-07-04 |
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EN ISO 1135-3:2017
(WI=00205308) Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016) |
2017-02-22 |
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EN ISO 1135-4:2015
(WI=00205273) Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015) |
2015-12-23 |
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EN ISO 1135-5:2015
(WI=00205282) Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015) |
2015-12-23 |
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EN ISO 11608-1:2022
(WI=00205332) Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022) |
2022-05-04 |
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EN ISO 11608-2:2022
(WI=00205333) Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022) |
2022-05-04 |
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EN ISO 11608-3:2022
(WI=00205347) Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01) |
2022-05-04 |
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EN ISO 11608-4:2022
(WI=00205350) Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022) |
2022-05-04 |
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EN ISO 11608-5:2023
(WI=00205390) Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022) |
2023-03-22 |
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EN ISO 11608-7:2017
(WI=00205300) Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016) |
2017-08-02 |
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EN ISO 20072:2013
(WI=00205269) Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009) |
2013-02-06 |
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EN ISO 20695:2020
(WI=00205292) Enteral feeding systems - Design and testing (ISO 20695:2020) |
2020-04-08 |
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EN ISO 20696:2018
(WI=00205323) Sterile urethral catheters for single use (ISO 20696:2018, Corrected version 2019-12) |
2018-07-04 |
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EN ISO 20697:2018
(WI=00205324) Sterile drainage catheters and accessory devices for single use (ISO 20697:2018, Corrected version 2018-09) |
2018-07-04 |
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EN ISO 21171:2006
(WI=00205160) Medical gloves - Determination of removable surface powder (ISO 21171:2006) |
2006-05-01 |
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EN ISO 22413:2021
(WI=00205362) Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021) |
2021-06-23 |
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EN ISO 22610:2006
(WI=00205155) 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) |
2006-07-01 |
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EN ISO 22612:2005
(WI=00205154) Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005) |
2005-03-01 |
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EN ISO 23500-1:2024
(WI=00205376) Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2024) |
2024-09-04 |
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EN ISO 23500-2:2024
(WI=00205377) Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2024) |
2024-07-31 |
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EN ISO 23500-3:2024
(WI=00205378) Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024) |
2024-04-24 |
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EN ISO 23500-4:2024
(WI=00205379) Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2024) |
2024-04-24 |
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EN ISO 23500-5:2024
(WI=00205380) Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2024) |
2024-04-24 |
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EN ISO 23907-1:2019
(WI=00205331) Sharps injury protection - Requirements and test methods - Part 1: Single-use sharps containers (ISO 23907-1:2019) |
2019-02-13 |
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EN ISO 23908:2013
(WI=00205271) Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011) |
2013-02-06 |
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EN ISO 24072:2023
(WI=00205369) Aerosol bacterial retention test method for air-inlet on administration devices (ISO 24072:2023) |
2023-07-05 |
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EN ISO 3826-1:2019
(WI=00205327) Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019) |
2019-10-16 |
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EN ISO 3826-1:2019/A1:2023
(WI=00205374) Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023) |
2023-04-05 |
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EN ISO 3826-2:2008
(WI=00205180) Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008) |
2008-08-01 |
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EN ISO 3826-3:2007
(WI=00205179) Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006) |
2007-12-12 |
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EN ISO 3826-4:2015
(WI=00205272) Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015) |
2015-08-19 |
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EN ISO 4074:2015
(WI=00205315) Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015) |
2015-11-11 |
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EN ISO 6009:2016
(WI=00205278) Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016) |
2016-08-31 |
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EN ISO 7199:2024
(WI=00205365) Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2024) |
2024-09-11 |
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EN ISO 7864:2016
(WI=00205251) Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
2016-08-31 |
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EN ISO 7886-1:2018
(WI=00205283) Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017, Corrected version 2019-08) |
2018-03-28 |
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EN ISO 7886-2:2020
(WI=00205345) Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:2020) |
2020-05-13 |
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EN ISO 7886-3:2020
(WI=00205353) Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization (ISO 7886-3:2020) |
2020-05-20 |
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EN ISO 7886-4:2019
(WI=00205325) Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2018) |
2019-03-06 |
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EN ISO 80601-2-56:2017
(WI=00205309) Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017) |
2017-07-26 |
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EN ISO 80601-2-56:2017/A1:2020
(WI=00205342) Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement - Amendment 1 (ISO 80601-2-56:2017/Amd 1:2018) |
2020-05-06 |
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EN ISO 81060-1:2012
(WI=00205242) Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007) |
2012-05-23 |
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EN ISO 81060-2:2019
(WI=00205339) Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018) |
2019-11-27 |
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EN ISO 81060-2:2019/A1:2020
(WI=00205361) Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020) |
2020-09-16 |
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EN ISO 81060-2:2019/A2:2024
(WI=00205385) Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 2 (ISO 81060-2:2018/Amd 2:2024) |
2024-04-03 |
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EN ISO 81060-3:2023
(WI=00205346) Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO 81060-3:2022) |
2023-01-11 |
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EN ISO 8362-5:2016
(WI=00205301) Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016) |
2016-03-16 |
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EN ISO 8362-6:2011
(WI=00205189) Injection containers and accessories - Part 6: Caps made of aluminium-plastics combinations for injection vials (ISO 8362-6:2010) |
2011-04-27 |
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EN ISO 8362-7:2010
(WI=00205190) Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part (ISO 8362-7:2006) |
2010-12-08 |
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EN ISO 8536-10:2015
(WI=00205276) Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015) |
2015-06-17 |
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EN ISO 8536-11:2015
(WI=00205277) Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015) |
2015-06-17 |
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EN ISO 8536-12:2021
(WI=00205355) Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-12:2021) |
2021-02-17 |
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EN ISO 8536-13:2024
(WI=00205387) Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2024) |
2024-09-25 |
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EN ISO 8536-14:2018
(WI=00205311) Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (ISO 8536-14:2016) |
2018-02-07 |
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EN ISO 8536-15:2022
(WI=00205363) Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use (ISO 8536-15:2022) |
2022-03-23 |
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EN ISO 8536-15:2022/A1:2023
(WI=00205389) Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use - Amendment 1 (ISO 8536-15:2022/Amd 1:2023) |
2023-03-15 |
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EN ISO 8536-4:2020
(WI=00205328) Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019) |
2020-01-29 |
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EN ISO 8536-5:2013
(WI=00205266) Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2004) |
2013-02-06 |
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EN ISO 8536-8:2015
(WI=00205274) Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015) |
2015-06-17 |
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EN ISO 8536-9:2015
(WI=00205275) Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015) |
2015-06-17 |
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EN ISO 8537:2016
(WI=00205252) Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016) |
2016-04-13 |
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EN ISO 8637-1:2020
(WI=00205321) Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017) |
2020-04-15 |
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EN ISO 8637-2:2024
(WI=00205360) Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024) |
2024-04-17 |
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EN ISO 8871-1:2004
(WI=00205286) Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003) |
2004-09-01 |
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EN ISO 8871-2:2020
(WI=00205349) Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020) |
2020-06-03 |
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EN ISO 8871-3:2004
(WI=00205288) Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003) |
2004-05-26 |
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EN ISO 8871-3:2004/A1:2019
(WI=00205343) Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count - Amendment 1 (ISO 8871-3:2003/Amd 1:2018) |
2019-03-27 |
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EN ISO 8871-4:2006
(WI=00205289) Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006) |
2006-06-15 |
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EN ISO 8871-5:2016
(WI=00205314) Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016) |
2016-11-23 |
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EN ISO 9626:2016
(WI=00205253) Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016) |
2016-08-31 |
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