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Thread: CEN Standards Collection 336/370: CEN TC 205-Non-Active Medical Devices

  1. #1

    CEN Standards Collection 336/370: CEN TC 205-Non-Active Medical Devices

    I'm pretty sure that I have already post this CEN sector, but I can't find it via advanced search (don't know what happened)...anyway,

    full list:
    EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
    EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties
    EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
    EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
    EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
    EN ISO 1135-4:2015 Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)
    EN ISO 1135-5:2015 Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)
    EN 1615:2000 Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing
    EN 1616:1997 Sterile urethral catheters for single use
    EN 1616:1997/A1:1999 Sterile urethral catheters for single use
    EN 1617:1997 Sterile drainage catheters and accessory devices for single use
    EN 1618:1997 Catheters other than intravascular catheters - Test methods for common properties
    EN 1644-1:1997 Test methods for nonwoven compresses for medical use - Part 1: Nonwovens used in the manufacture of compresses
    EN 1644-2:2000 Test methods for nonwoven compresses for medical use - Part 2: Finished compresses
    EN 1707:1996 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings
    EN ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
    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)
    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)
    EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
    EN ISO 4074:2015 Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
    EN ISO 6009:2016 Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)
    EN ISO 7199:2014 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012)
    EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    EN ISO 7886-1:1997 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:1993, including Technical Corrigendum 1:1995)
    EN ISO 7886-2:1997 Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:1996)
    EN ISO 7886-3:2009 Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)
    EN ISO 7886-4:2009 Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)
    EN ISO 8362-5:2016 Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)
    EN ISO 8362-6:2011 Injection containers and accessories - Part 6: Caps made of aluminium-plastics combinations for injection vials (ISO 8362-6:2010)
    EN ISO 8362-7:2010 Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part (ISO 8362-7:2006)
    EN ISO 8536-4:2013 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010)
    EN ISO 8536-4:2013/A1:2013 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010/Amd 1:2013)
    EN ISO 8536-5:2013 Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2004)
    EN ISO 8536-8:2015 Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015)
    EN ISO 8536-9:2015 Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015)
    EN ISO 8536-10:2015 Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015)
    EN ISO 8536-11:2015 Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015)
    EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
    EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
    EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
    EN ISO 8871-1:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003)
    EN ISO 8871-2:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003)
    EN ISO 8871-2:2004/A1:2014 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization - Amendment 1 (ISO 8871-2:2003/Amd 1:2005)
    EN ISO 8871-3:2004 Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003)
    EN ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)
    EN ISO 8871-5:2014 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2005)
    EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
    EN ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013, Corrected version 2014-01-15)
    EN ISO 10555-3:2013 Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013)
    EN ISO 10555-4:2013 Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013)
    EN ISO 10555-5:2013 Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters (ISO 10555-5:2013)
    EN ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014)
    EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
    EN ISO 11608-1:2015 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
    EN ISO 11608-2:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)
    EN ISO 11608-3:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012)
    EN ISO 11608-4:2007 Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006)
    EN ISO 11608-5:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
    EN 12439:1998 Sterile rectal catheters for single use
    EN 12470-1:2000+A1:2009 Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
    EN 12470-2:2000+A1:2009 Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
    EN 13726-1:2002 Test methods for primary wound dressings - Part 1: Aspects of absorbency
    EN 13726-1:2002/AC:2003 Test methods for primary wound dressings - Part 1: Aspects of absorbency
    EN 13726-2:2002 Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings
    EN 13726-3:2003 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
    EN 13726-4:2003 Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
    EN 13726-6:2003 Non-active medical devices - Test methods for primary wound dressing - Part 6: Odour control
    EN 13795:2011+A1:2013 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
    EN 13868:2002 Catheters - Test methods for kinking of single lumen catheters and medical tubing
    EN ISO 13958:2015 Concentrates for haemodialysis and related therapies (ISO 13958:2014)
    EN ISO 13959:2015 Water for haemodialysis and related therapies (ISO 13959:2014)
    EN 14079:2003 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
    EN 14683:2014 Medical face masks - Requirements and test methods
    CEN/TR 15831:2009 Method for testing compression in medical hosiery
    EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
    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)
    EN 20594-1:1993/AC:1996 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)
    EN 20594-1:1993/A1:1997 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)
    EN ISO 21171:2006 Medical gloves - Determination of removable surface powder (ISO 21171:2006)
    EN ISO 22413:2013 Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010)
    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)
    EN ISO 22612:2005 Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)
    EN ISO 23500:2015 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014)
    EN ISO 23907:2012 Sharps injury protection - Requirements and test methods - Sharps containers (ISO 23907:2012)
    EN ISO 23908:2013 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)
    EN ISO 26722:2015 Water treatment equipment for haemodialysis applications and related therapies (ISO 26722:2014)
    EN 27740:1992 Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)
    EN 27740:1992/AC:1996 Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)
    EN 27740:1992/A1:1997 Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)
    EN ISO 80601-2-56:2012 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009)
    EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
    EN ISO 81060-2:2014 Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)


    missing are:

    EN ISO 6009:2016 Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)
    EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    EN ISO 7886-1:1997 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:1993, including Technical Corrigendum 1:1995)
    EN ISO 8536-5:2013 Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2004)
    EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
    EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
    EN 13726-1:2002/AC:2003 Test methods for primary wound dressings - Part 1: Aspects of absorbency
    CEN/TR 15831:2009 Method for testing compression in medical hosiery
    EN 20594-1:1993/A1:1997 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)
    EN 27740:1992/AC:1996 Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)
    EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)


    links:

    [link Point to another website Only the registered members can access]
    or

    [link Point to another website Only the registered members can access]


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  3. #2

    Re: CEN Standards Collection 336/350: CEN TC 205-Non-Active Medical Devices

    update:

    EN ISO 6009:2016 Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016) - added missing standard
    EN ISO 7886-1:1997 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:1993, including Technical Corrigendum 1:1995) - added missing standard
    EN ISO 8536-5:2013 Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2004) - added missing standard
    EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016) - added missing standard
    EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016) - added missing standard
    EN 13726-1:2002/AC:2003 Test methods for primary wound dressings - Part 1: Aspects of absorbency - added missing AC
    EN 27740:1992/AC:1996 Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) - added missing AC
    EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007) - added missing standard

    missing list:

    EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    EN ISO 8536-13:2016 Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)
    CEN/TR 15831:2009 Method for testing compression in medical hosiery
    EN 20594-1:1993/A1:1997 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)


    new links:

    [link Point to another website Only the registered members can access]
    or

    [link Point to another website Only the registered members can access]


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  5. #3

    Re: CEN Standards Collection 336/370: CEN TC 205-Non-Active Medical Devices

    update:

    EN ISO 8536-13:2016 Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016) - added missing standard
    EN ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016) - added new standard


    still missing:

    EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    CEN/TR 15831:2009 Method for testing compression in medical hosiery
    EN 20594-1:1993/A1:1997 Conical fittings with a 6% (Luer) taper for syringes* needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)


    new link:

    [link Point to another website Only the registered members can access]


  6. #4

    Re: CEN Standards Collection 336/370: CEN TC 205-Non-Active Medical Devices

    update:

    added missing/new standards:

    EN ISO 7199:2017 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
    EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)


    the missing two now are:

    CEN/TR 15831:2009 Method for testing compression in medical hosiery
    EN 20594-1:1993/A1:1997 Conical fittings with a 6% (Luer) taper for syringes* needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)


    new link:

    [link Point to another website Only the registered members can access]


  7. #5

    Re: CEN Standards Collection 336/370: CEN TC 205-Non-Active Medical Devices

    update:

    new* missing* EN* BQ:

    EN ISO 1135-3:2017 Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)
    EN 1615:2000 Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing
    EN 1707:1996 Conical fittings with a 6 % (Luer) taper for syringes* needles and certain other medical equipment - Lock fittings
    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)
    EN ISO 6009:2016 Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)
    EN ISO 7199:2017 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
    EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    EN ISO 7886-1:1997 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:1993* including Technical Corrigendum 1:1995)
    EN ISO 7886-2:1997 Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:1996)
    EN ISO 8362-5:2016 Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)
    EN ISO 8536-5:2013 Infusion equipment for medical use - Part 5: Burette infusion sets for single use* gravity feed (ISO 8536-5:2004)
    EN ISO 8536-13:2016 Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)
    EN ISO 8871-1:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003)
    EN ISO 8871-3:2004 Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003)
    EN ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)
    EN ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016)
    EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
    EN ISO 10555-6:2017 Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)
    EN ISO 11608-4:2007 Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006)
    EN ISO 11608-7:2017 Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)
    EN 13726-1:2002 Test methods for primary wound dressings - Part 1: Aspects of absorbency
    EN 13726-2:2002 Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings
    EN 13726-3:2003 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
    EN 13726-4:2003 Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
    EN 13726-6:2003 Non-active medical devices - Test methods for primary wound dressing - Part 6: Odour control
    EN 13795:2011+A1:2013 Surgical drapes* gowns and clean air suits* used as medical devices for patients* clinical staff and equipment - General requirements for manufacturers* processors and products* test methods* performance requirements and performance levels
    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)
    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)
    EN ISO 22612:2005 Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)
    EN ISO 23907:2012 Sharps injury protection - Requirements and test methods - Sharps containers (ISO 23907:2012)
    EN ISO 23908:2013 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)
    EN ISO 80601-2-56:2017 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)
    EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)


    the missing:

    CEN/TR 15831:2009 Method for testing compression in medical hosiery
    EN 20594-1:1993/A1:1997 Conical fittings with a 6% (Luer) taper for syringes* needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)


    [link Point to another website Only the registered members can access]


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