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Thread: ISO Collection 95/300:ISO/TC 76 - Transfusion* infusion and injection* and blood

  1. #1

    ISO Collection 95/300:ISO/TC 76 - Transfusion* infusion and injection* and blood

    the list:

    ISO 1135-3:2016 Transfusion equipment for medical use -- Part 3: Blood-taking sets for single use
    ISO 1135-4:2015 Transfusion equipment for medical use -- Part 4: Transfusion sets for single use, gravity feed
    ISO 1135-5:2015 Transfusion equipment for medical use -- Part 5: Transfusion sets for single use with pressure infusion apparatus
    ISO 3826-1:2015 Plastics collapsible containers for human blood and blood components -- Part 1: Conventional containers
    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 3826-3:2006 Plastics collapsible containers for human blood and blood components -- Part 3: Blood bag systems with integrated features
    ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components -- Part 4: Aphaeresis blood bag systems with integrated features
    ISO 4802-1:2016 Glassware -- Hydrolytic resistance of the interior surfaces of glass containers -- Part 1: Determination by titration method and classification
    ISO 4802-2:2016 Glassware -- Hydrolytic resistance of the interior surfaces of glass containers -- Part 2: Determination by flame spectrometry and classification
    ISO 6710:1995 Single-use containers for venous blood specimen collection
    ISO 8362-1:2009 Injection containers and accessories -- Part 1: Injection vials made of glass tubing
    ISO 8362-1:2009/Amd 1:2015 Injection containers and accessories -- Part 1: Injection vials made of glass tubing
    ISO 8362-2:2015 Injection containers and accessories -- Part 2: Closures for injection vials
    ISO 8362-3:2001 Injection containers and accessories -- Part 3: Aluminium caps for injection vials
    ISO 8362-4:2011 Injection containers and accessories -- Part 4: Injection vials made of moulded glass
    ISO 8362-5:2016 Injection containers and accessories -- Part 5: Freeze drying closures for injection vials
    ISO 8362-6:2010 Injection containers and accessories -- Part 6: Caps made of aluminium-plastics combinations for injection vials
    ISO 8362-7:2006 Injection containers and accessories -- Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part
    ISO 8536-1:2011 Infusion equipment for medical use -- Part 1: Infusion glass bottles
    ISO 8536-2:2010 Infusion equipment for medical use -- Part 2: Closures for infusion bottles
    ISO 8536-3:2009 Infusion equipment for medical use -- Part 3: Aluminium caps for infusion bottles
    ISO 8536-4:2010 Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed
    ISO 8536-4:2010/Amd 1:2013 Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed
    ISO 8536-5:2004 Infusion equipment for medical use -- Part 5: Burette infusion sets for single use, gravity feed
    ISO 8536-6:2016 Infusion equipment for medical use -- Part 6: Freeze drying closures for infusion bottles
    ISO 8536-7:2009 Infusion equipment for medical use -- Part 7: Caps made of aluminium-plastics combinations for infusion bottles
    ISO 8536-8:2015 Infusion equipment for medical use -- Part 8: Infusion sets for single use with pressure infusion apparatus
    ISO 8536-9:2015 Infusion equipment for medical use -- Part 9: Fluid lines for single use with pressure infusion equipment
    ISO 8536-10:2015 Infusion equipment for medical use -- Part 10: Accessories for fluid lines for single use with pressure infusion equipment
    ISO 8536-11:2015 Infusion equipment for medical use -- Part 11: Infusion filters for single use with pressure infusion equipment
    ISO 8536-12:2007 Infusion equipment for medical use -- Part 12: Check valves
    ISO 8536-12:2007/Amd 1:201 Infusion equipment for medical use -- Part 12: Check valves
    ISO 8536-13:2016 Infusion equipment for medical use -- Part 13: Graduated flow regulators for single use with fluid contact
    ISO 8536-14:2016 Infusion equipment for medical use -- Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
    ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 1: Extractables in aqueous autoclavates
    ISO 8871-2:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 2: Identification and characterization
    ISO 8871-2:2003/Amd 1:2005 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 2: Identification and characterization
    ISO 8871-3:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 3: Determination of released-particle count
    ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 4: Biological requirements and test methods
    ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 5: Functional requirements and testing
    ISO 8872:2003 Aluminium caps for transfusion, infusion and injection bottles -- General requirements and test methods
    ISO 9187-1:2010 Injection equipment for medical use -- Part 1: Ampoules for injectables
    ISO 9187-2:2010 Injection equipment for medical use -- Part 2: One-point-cut (OPC) ampoules
    ISO 10985:2009 Caps made of aluminium-plastics combinations for infusion bottles and injection vials -- Requirements and test methods
    ISO 11040-1:2015 Prefilled syringes -- Part 1: Glass cylinders for dental local anaesthetic cartridges
    ISO 11040-2:2011 Prefilled syringes -- Part 2: Plunger stoppers for dental local anaesthetic cartridges
    ISO 11040-3:2012 Prefilled syringes -- Part 3: Seals for dental local anaesthetic cartridges
    ISO 11040-4:2015 Prefilled syringes -- Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
    ISO 11040-5:2012 Prefilled syringes -- Part 5: Plunger stoppers for injectables
    ISO 11040-6:2012 Prefilled syringes -- Part 6: Plastic barrels for injectables
    ISO 11040-7:2015 Prefilled syringes -- Part 7: Packaging systems for sterilized subassembled syringes ready for filling
    ISO 11040-8:2016 Prefilled syringes -- Part 8: Requirements and test methods for finished prefilled syringes
    ISO 11418-1:2016 Containers and accessories for pharmaceutical preparations -- Part 1: Drop-dispensing glass bottles
    ISO 11418-2:2016 Containers and accessories for pharmaceutical preparations -- Part 2: Screw-neck glass bottles for syrups
    ISO 11418-3:2016 Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms
    ISO 11418-4:2005 Containers and accessories for pharmaceutical preparations -- Part 4: Tablet glass bottles
    ISO 11418-5:2015 Containers and accessories for pharmaceutical preparations -- Part 5: Dropper assemblies
    ISO 11418-7:2016 Containers and accessories for pharmaceutical preparations -- Part 7: Screw-neck vials made of glass tubing for liquid dosage forms
    ISO 13926-1:2004 Pen systems -- Part 1: Glass cylinders for pen-injectors for medical use
    ISO 13926-2:2011 Pen systems -- Part 2: Plunger stoppers for pen-injectors for medical use
    ISO 13926-2:2011/Amd 1:2015 Pen systems -- Part 2: Plunger stoppers for pen-injectors for medical use
    ISO 13926-3:2012 Pen systems -- Part 3: Seals for pen-injectors for medical use
    ISO 15010:1998 Disposable hanging devices for transfusion and infusion bottles -- Requirements and test methods
    ISO 15137:2005 Self-adhesive hanging devices for infusion bottles and injection vials -- Requirements and test methods
    ISO 15375:2010 Medical infusion bottles -- Suspension devices for multiple use -- Requirements and test methods
    ISO 15378:2015 Primary packaging materials for *******al products -- Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
    ISO 15747:2010 Plastic containers for intravenous injections
    ISO 15759:2005 Medical infusion equipment -- Plastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process
    ISO 22413:2010 Transfer sets for pharmaceutical preparations -- Requirements and test methods
    ISO 28620:2010 Medical devices -- Non-electrically driven portable infusion devices


    missing are:

    ISO 1135-3:2016 Transfusion equipment for medical use -- Part 3: Blood-taking sets for single use
    ISO 8536-6:2016 Infusion equipment for medical use -- Part 6: Freeze drying closures for infusion bottles
    ISO 8536-13:2016 Infusion equipment for medical use -- Part 13: Graduated flow regulators for single use with fluid contact
    ISO 8536-14:2016 Infusion equipment for medical use -- Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
    ISO 8871-2:2003/Amd 1:2005 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 2: Identification and characterization
    ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 5: Functional requirements and testing
    ISO 11040-8:2016 Prefilled syringes -- Part 8: Requirements and test methods for finished prefilled syringes
    ISO 11418-1:2016 Containers and accessories for pharmaceutical preparations -- Part 1: Drop-dispensing glass bottles
    ISO 11418-2:2016 Containers and accessories for pharmaceutical preparations -- Part 2: Screw-neck glass bottles for syrups
    ISO 11418-3:2016 Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms


    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: ISO Collection 95/300:ISO/TC 76 - Transfusion* infusion and injection* and blood

    update:

    added missing:

    ISO 1135-3:2016 Transfusion equipment for medical use -- Part 3: Blood-taking sets for single use
    ISO 8536-13:2016 Infusion equipment for medical use -- Part 13: Graduated flow regulators for single use with fluid contact
    ISO 8536-14:2016 Infusion equipment for medical use -- Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
    ISO 8871-2:2003/Amd 1:2005 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 2: Identification and characterization
    ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 5: Functional requirements and testing
    ISO 11040-8:2016 Prefilled syringes -- Part 8: Requirements and test methods for finished prefilled syringes
    ISO 11418-1:2016 Containers and accessories for pharmaceutical preparations -- Part 1: Drop-dispensing glass bottles
    ISO 11418-2:2016 Containers and accessories for pharmaceutical preparations -- Part 2: Screw-neck glass bottles for syrups
    ISO 11418-3:2016 Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms


    only one that's missing now is:

    ISO 8536-6:2016 Infusion equipment for medical use -- Part 6: Freeze drying closures for infusion bottles

    new link:

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


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  5. #3

    Re: ISO Collection 95/300:ISO/TC 76 - Transfusion* infusion and injection* and blood

    update:

    beter quality or EN versions:

    ISO 1135-3:2016 Transfusion equipment for medical use -- Part 3: Blood-taking sets for single use
    ISO 8536-13:2016 Infusion equipment for medical use -- Part 13: Graduated flow regulators for single use with fluid contact
    ISO 8536-14:2016 Infusion equipment for medical use -- Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
    ISO 3826-3:2006 Plastics collapsible containers for human blood and blood components -- Part 3: Blood bag systems with integrated features
    ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 1: Extractables in aqueous autoclavates
    ISO 8871-2:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 2: Identification and characterization
    ISO 8871-3:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 3: Determination of released-particle count
    ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 4: Biological requirements and test methods
    ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 5: Functional requirements and testing
    ISO 11040-8:2016 Prefilled syringes -- Part 8: Requirements and test methods for finished prefilled syringes
    ISO 11418-1:2016 Containers and accessories for pharmaceutical preparations -- Part 1: Drop-dispensing glass bottles
    ISO 11418-2:2016 Containers and accessories for pharmaceutical preparations -- Part 2: Screw-neck glass bottles for syrups
    ISO 11418-3:2016 Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms
    ISO 15010:1998 Disposable hanging devices for transfusion and infusion bottles -- Requirements and test methods
    ISO 15747:2010 Plastic containers for intravenous injections
    ISO 28620:2010 Medical devices -- Non-electrically driven portable infusion devices


    added missing:

    ISO 8536-6:2016 Infusion equipment for medical use -- Part 6: Freeze drying closures for infusion bottles


    complete!


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


  6. #4

    Re: ISO Collection 95/300:ISO/TC 76 - Transfusion* infusion and injection* and blood

    EN version:
    ISO 15137:2005 Self-adhesive hanging devices for infusion bottles and injection vials -- Requirements and test methods

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


  7. #5

    Re: ISO Collection 95/300:ISO/TC 76 - Transfusion* infusion and injection* and blood

    full list 09.12.2017

    ISO 1135-3:2016 Transfusion equipment for medical use -- Part 3: Blood-taking sets for single use
    ISO 1135-4:2015 Transfusion equipment for medical use -- Part 4: Transfusion sets for single use, gravity feed
    ISO 1135-5:2015 Transfusion equipment for medical use -- Part 5: Transfusion sets for single use with pressure infusion apparatus
    ISO 3826-1:2015 Plastics collapsible containers for human blood and blood components -- Part 1: Conventional containers
    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 3826-3:2006 Plastics collapsible containers for human blood and blood components -- Part 3: Blood bag systems with integrated features
    ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components -- Part 4: Aphaeresis blood bag systems with integrated features
    ISO 4802-1:2016 Glassware -- Hydrolytic resistance of the interior surfaces of glass containers -- Part 1: Determination by titration method and classification
    ISO 4802-2:2016 Glassware -- Hydrolytic resistance of the interior surfaces of glass containers -- Part 2: Determination by flame spectrometry and classification
    ISO 6710:2017 Single-use containers for human venous blood specimen collection
    ISO 8362-1:2009 Injection containers and accessories -- Part 1: Injection vials made of glass tubing
    ISO 8362-1:2009/Amd 1:2015 Injection containers and accessories -- Part 1: Injection vials made of glass tubing
    ISO 8362-2:2015 Injection containers and accessories -- Part 2: Closures for injection vials
    ISO 8362-3:2001 Injection containers and accessories -- Part 3: Aluminium caps for injection vials
    ISO 8362-4:2011 Injection containers and accessories -- Part 4: Injection vials made of moulded glass
    ISO 8362-5:2016 Injection containers and accessories -- Part 5: Freeze drying closures for injection vials
    ISO 8362-6:2010 Injection containers and accessories -- Part 6: Caps made of aluminium-plastics combinations for injection vials
    ISO 8362-7:2006 Injection containers and accessories -- Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part
    ISO 8536-1:2011 Infusion equipment for medical use -- Part 1: Infusion glass bottles
    ISO 8536-2:2010 Infusion equipment for medical use -- Part 2: Closures for infusion bottles
    ISO 8536-3:2009 Infusion equipment for medical use -- Part 3: Aluminium caps for infusion bottles
    ISO 8536-4:2010 Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed
    ISO 8536-4:2010/Amd 1:2013 Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed
    ISO 8536-5:2004 Infusion equipment for medical use -- Part 5: Burette infusion sets for single use, gravity feed
    ISO 8536-6:2016 Infusion equipment for medical use -- Part 6: Freeze drying closures for infusion bottles
    ISO 8536-7:2009 Infusion equipment for medical use -- Part 7: Caps made of aluminium-plastics combinations for infusion bottles
    ISO 8536-8:2015 Infusion equipment for medical use -- Part 8: Infusion sets for single use with pressure infusion apparatus
    ISO 8536-9:2015 Infusion equipment for medical use -- Part 9: Fluid lines for single use with pressure infusion equipment
    ISO 8536-10:2015 Infusion equipment for medical use -- Part 10: Accessories for fluid lines for single use with pressure infusion equipment
    ISO 8536-11:2015 Infusion equipment for medical use -- Part 11: Infusion filters for single use with pressure infusion equipment
    ISO 8536-12:2007 Infusion equipment for medical use -- Part 12: Check valves
    ISO 8536-12:2007/Amd 1:201 Infusion equipment for medical use -- Part 12: Check valves
    ISO 8536-13:2016 Infusion equipment for medical use -- Part 13: Graduated flow regulators for single use with fluid contact
    ISO 8536-14:2016 Infusion equipment for medical use -- Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
    ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 1: Extractables in aqueous autoclavates
    ISO 8871-2:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 2: Identification and characterization
    ISO 8871-2:2003/Amd 1:2005 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 2: Identification and characterization
    ISO 8871-3:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 3: Determination of released-particle count
    ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 4: Biological requirements and test methods
    ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 5: Functional requirements and testing
    ISO 8872:2003 Aluminium caps for transfusion, infusion and injection bottles -- General requirements and test methods
    ISO 9187-1:2010 Injection equipment for medical use -- Part 1: Ampoules for injectables
    ISO 9187-2:2010 Injection equipment for medical use -- Part 2: One-point-cut (OPC) ampoules
    ISO 10985:2009 Caps made of aluminium-plastics combinations for infusion bottles and injection vials -- Requirements and test methods
    ISO 11040-1:2015 Prefilled syringes -- Part 1: Glass cylinders for dental local anaesthetic cartridges
    ISO 11040-2:2011 Prefilled syringes -- Part 2: Plunger stoppers for dental local anaesthetic cartridges
    ISO 11040-3:2012 Prefilled syringes -- Part 3: Seals for dental local anaesthetic cartridges
    ISO 11040-4:2015 Prefilled syringes -- Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
    ISO 11040-5:2012 Prefilled syringes -- Part 5: Plunger stoppers for injectables
    ISO 11040-6:2012 Prefilled syringes -- Part 6: Plastic barrels for injectables
    ISO 11040-7:2015 Prefilled syringes -- Part 7: Packaging systems for sterilized subassembled syringes ready for filling
    ISO 11040-8:2016 Prefilled syringes -- Part 8: Requirements and test methods for finished prefilled syringes
    ISO 11418-1:2016 Containers and accessories for pharmaceutical preparations -- Part 1: Drop-dispensing glass bottles
    ISO 11418-2:2016 Containers and accessories for pharmaceutical preparations -- Part 2: Screw-neck glass bottles for syrups
    ISO 11418-2:2016/Amd 1:2017 Containers and accessories for pharmaceutical preparations -- Part 2: Screw-neck glass bottles for syrups
    ISO 11418-3:2016 Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms
    ISO 11418-3:2016/Amd 1:2017 Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms
    ISO 11418-4:2005 Containers and accessories for pharmaceutical preparations -- Part 4: Tablet glass bottles
    ISO 11418-5:2015 Containers and accessories for pharmaceutical preparations -- Part 5: Dropper assemblies
    ISO 11418-7:2016 Containers and accessories for pharmaceutical preparations -- Part 7: Screw-neck vials made of glass tubing for liquid dosage forms
    ISO 13926-1:2004 Pen systems -- Part 1: Glass cylinders for pen-injectors for medical use
    ISO 13926-2:2017 Pen systems -- Part 2: Plunger stoppers for pen-injectors for medical use
    ISO 13926-3:2012 Pen systems -- Part 3: Seals for pen-injectors for medical use
    ISO 15010:1998 Disposable hanging devices for transfusion and infusion bottles -- Requirements and test methods
    ISO 15137:2005 Self-adhesive hanging devices for infusion bottles and injection vials -- Requirements and test methods
    ISO 15375:2010 Medical infusion bottles -- Suspension devices for multiple use -- Requirements and test methods
    ISO 15378:2017 Primary packaging materials for *******al products -- Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
    ISO 15747:2010 Plastic containers for intravenous injections
    ISO 15759:2005 Medical infusion equipment -- Plastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process
    ISO/TR 19727:2017 Medical devices -- Pump tube spallation test -- General procedure
    ISO 22413:2010 Transfer sets for pharmaceutical preparations -- Requirements and test methods
    ISO 28620:2010 Medical devices -- Non-electrically driven portable infusion devices


    the missing:

    ISO 11418-2:2016/Amd 1:2017 Containers and accessories for pharmaceutical preparations -- Part 2: Screw-neck glass bottles for syrups
    ISO 11418-3:2016/Amd 1:2017 Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms
    ISO 13926-2:2017 Pen systems -- Part 2: Plunger stoppers for pen-injectors for medical use


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


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