Standards catalogue

ISO/TC 76

Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

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Standard and/or project under the direct responsibility of ISO/TC 76 Secretariat Stage ICS
ISO 719:1981 [Withdrawn]
Glass -- Hydrolytic resistance of glass grains at 98 degrees C -- Method of test and classification
95.99
ISO 719:1985
Glass -- Hydrolytic resistance of glass grains at 98 degrees C -- Method of test and classification
90.60
ISO 720:1981 [Withdrawn]
Glass -- Hydrolytic resistance of glass grains at 121 degrees C -- Method of test and classification
95.99
ISO 720:1985
Glass -- Hydrolytic resistance of glass grains at 121 degrees C -- Method of test and classification
90.93
ISO 1135:1977 [Withdrawn]
Transfusion equipment for medical use
95.99
ISO 1135-1:1986 [Withdrawn]
Transfusion equipment for medical use -- Part 1: Glass transfusion bottles, closures and bottle caps
95.99
ISO 1135-1:1987 [Withdrawn]
Transfusion equipment for medical use -- Part 1: Glass transfusion bottles, closures and caps
95.99
ISO 1135-3:1986 [Withdrawn]
Transfusion equipment for medical use -- Part 3: Blood-taking set
95.99
ISO 1135-3:2016
Transfusion equipment for medical use -- Part 3: Blood-taking sets for single use
60.60
ISO 1135-4:1987 [Withdrawn]
Transfusion equipment for medical use -- Part 4: Transfusion sets for single use
95.99
ISO 1135-4:1998 [Withdrawn]
Transfusion equipment for medical use -- Part 4: Transfusion sets for single use
95.99
ISO 1135-4:2004 [Withdrawn]
Transfusion equipment for medical use -- Part 4: Transfusion sets for single use
95.99
ISO 1135-4:2010 [Withdrawn]
Transfusion equipment for medical use -- Part 4: Transfusion sets for single use
95.99
ISO 1135-4:2012 [Withdrawn]
Transfusion equipment for medical use -- Part 4: Transfusion sets for single use
95.99
ISO 1135-4:2015
Transfusion equipment for medical use -- Part 4: Transfusion sets for single use, gravity feed
60.60
ISO 1135-5:2015
Transfusion equipment for medical use -- Part 5: Transfusion sets for single use with pressure infusion apparatus
60.60
ISO 3825:1977 [Withdrawn]
Glass transfusion bottles for medical use -- Chemical resistance
95.99
ISO 3826:1993 [Withdrawn]
Plastics collapsible containers for human blood and blood components
95.99
ISO 3826-1:2003 [Withdrawn]
Plastics collapsible containers for human blood and blood components -- Part 1: Conventional containers
95.99
ISO 3826-1:2013
Plastics collapsible containers for human blood and blood components -- Part 1: Conventional containers
90.92
ISO/WD 3826-1 [Under development]
Plastics collapsible containers for human blood and blood components -- Part 1: Conventional containers
20.20
ISO 3826-2:2008
Plastics collapsible containers for human blood and blood components -- Part 2: Graphical symbols for use on labels and instruction leaflets
90.93
ISO 3826-3:2006
Plastics collapsible containers for human blood and blood components -- Part 3: Blood bag systems with integrated features
90.93
ISO 3826-4:2015
Plastics collapsible containers for human blood and blood components -- Part 4: Aphaeresis blood bag systems with integrated features
60.60
ISO 4802-1:1988 [Withdrawn]
Glassware -- Hydrolytic resistance of the interior surfaces of glass containers -- Part 1: Determination by titration method and classification
95.99
ISO 4802-1:2010 [Withdrawn]
Glassware -- Hydrolytic resistance of the interior surfaces of glass containers -- Part 1: Determination by titration method and classification
95.99
ISO 4802-1:2016
Glassware -- Hydrolytic resistance of the interior surfaces of glass containers -- Part 1: Determination by titration method and classification
60.60
ISO 4802-2:1988 [Withdrawn]
Glassware -- Hydrolytic resistance of the interior surfaces of glass containers -- Part 2: Determination by flame spectrometry and classification
95.99
ISO 4802-2:2010 [Withdrawn]
Glassware -- Hydrolytic resistance of the interior surfaces of glass containers -- Part 2: Determination by flame spectrometry and classification
95.99
ISO 4802-2:2016
Glassware -- Hydrolytic resistance of the interior surfaces of glass containers -- Part 2: Determination by flame spectrometry and classification
60.60
ISO 4822:1981 [Withdrawn]
Single use blood specimen containers up to 25 ml capacity
95.99
ISO 6710:1995 [Withdrawn]
Single-use containers for venous blood specimen collection
95.99
ISO 6710:2017
Single-use containers for human venous blood specimen collection
60.60
ISO/WD 6717 [Under development]
In vitro diagnostic medical devices -- Single-use receptacles for the collection of specimens, other than blood, from humans
20.20
ISO 8362-1:1989 [Withdrawn]
Injection containers for injectables and accessories -- Part 1: Injection vials made of glass tubing
95.99
ISO 8362-1:2003 [Withdrawn]
Injection containers and accessories -- Part 1: Injection vials made of glass tubing
95.99
ISO 8362-1:2009
Injection containers and accessories -- Part 1: Injection vials made of glass tubing
90.93
60.60
ISO/DIS 8362-1 [Under development]
Injection containers and accessories -- Part 1: Injection vials made of glass tubing
40.20
ISO 8362-2:1988 [Withdrawn]
Injection containers for injectables and accessories -- Part 2: Closures for injection vials
95.99
ISO 8362-2:2008 [Withdrawn]
Injection containers and accessories -- Part 2: Closures for injection vials
95.99
ISO 8362-2:2015
Injection containers and accessories -- Part 2: Closures for injection vials
60.60
ISO 8362-3:1989 [Withdrawn]
Injection containers for injectables and accessories -- Part 3: Aluminium caps for injection vials
95.99
ISO 8362-3:2001
Injection containers and accessories -- Part 3: Aluminium caps for injection vials
90.93
ISO 8362-4:1989 [Withdrawn]
Injection containers for injectables and accessories -- Part 4: Injection vials made of moulded glass
95.99
ISO 8362-4:2003 [Withdrawn]
Injection containers and accessories -- Part 4: Injection vials made of moulded glass
95.99
ISO 8362-4:2011
Injection containers and accessories -- Part 4: Injection vials made of moulded glass
90.93
ISO 8362-5:1995 [Withdrawn]
Injection containers for injectables and accessories -- Part 5: Freeze drying closures for injection vials
95.99
ISO 8362-5:2008 [Withdrawn]
Injection containers and accessories -- Part 5: Freeze drying closures for injection vials
95.99
ISO 8362-5:2016
Injection containers and accessories -- Part 5: Freeze drying closures for injection vials
60.60
ISO 8362-6:1992 [Withdrawn]
Injection containers for injectables and accessories -- Part 6: Caps made of aluminium-plastics combinations for injection vials
95.99
ISO 8362-6:2010
Injection containers and accessories -- Part 6: Caps made of aluminium-plastics combinations for injection vials
90.93
ISO 8362-7:1995 [Withdrawn]
Injection containers for injectables and accessories -- Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part
95.99
ISO 8362-7:2006
Injection containers and accessories -- Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part
90.93
ISO 8536-1:1991 [Withdrawn]
Infusion equipment for medical use -- Part 1: Infusion glass bottles
95.99
ISO 8536-1:2000 [Withdrawn]
Infusion equipment for medical use -- Part 1: Infusion glass bottles
95.99
95.99
ISO 8536-1:2006 [Withdrawn]
Infusion equipment for medical use -- Part 1: Infusion glass bottles
95.99
ISO 8536-1:2011
Infusion equipment for medical use -- Part 1: Infusion glass bottles
90.93
ISO 8536-2:1992 [Withdrawn]
Infusion equipment for medical use -- Part 2: Closures for infusion bottles
95.99
ISO 8536-2:2001 [Withdrawn]
Infusion equipment for medical use -- Part 2: Closures for infusion bottles
95.99
95.99
ISO 8536-2:2010
Infusion equipment for medical use -- Part 2: Closures for infusion bottles
90.93
ISO 8536-3:1992 [Withdrawn]
Infusion equipment for medical use -- Part 3: Aluminium caps for infusion bottles
95.99
ISO 8536-3:1999 [Withdrawn]
Infusion equipment for medical use -- Part 3: Aluminium caps for infusion bottles
95.99
ISO 8536-3:2009
Infusion equipment for medical use -- Part 3: Aluminium caps for infusion bottles
90.93
ISO 8536-4:1987 [Withdrawn]
Infusion equipment for medical use -- Part 4: Infusion sets for single use
95.99
ISO 8536-4:1998 [Withdrawn]
Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed
95.99
ISO 8536-4:2004 [Withdrawn]
Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed
95.99
ISO 8536-4:2007 [Withdrawn]
Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed
95.99
ISO 8536-4:2010
Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed
90.92
60.60
ISO/WD 8536-4 [Under development]
Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed
20.20
ISO 8536-5:1992 [Withdrawn]
Infusion equipment for medical use -- Part 5: Burette type infusion sets
95.99
ISO 8536-5:2004
Infusion equipment for medical use -- Part 5: Burette infusion sets for single use, gravity feed
90.20
ISO 8536-6:1995 [Withdrawn]
Infusion equipment for medical use -- Part 6: Freeze drying closures for infusion bottles
95.99
ISO 8536-6:2009 [Withdrawn]
Infusion equipment for medical use -- Part 6: Freeze drying closures for infusion bottles
95.99
ISO 8536-6:2016
Infusion equipment for medical use -- Part 6: Freeze drying closures for infusion bottles
60.60
ISO 8536-7:1992 [Withdrawn]
Infusion equipment for medical use -- Part 7: Caps made of aluminium-plastics combinations for infusion bottles
95.99
ISO 8536-7:1999 [Withdrawn]
Infusion equipment for medical use -- Part 7: Caps made of aluminium-plastics combinations for infusion bottles
95.99
ISO 8536-7:2009
Infusion equipment for medical use -- Part 7: Caps made of aluminium-plastics combinations for infusion bottles
90.60
ISO 8536-8:2004 [Withdrawn]
Infusion equipment for medical use -- Part 8: Infusion equipment for use with pressure infusion apparatus
95.99
ISO 8536-8:2015
Infusion equipment for medical use -- Part 8: Infusion sets for single use with pressure infusion apparatus
60.60
ISO 8536-9:2004 [Withdrawn]
Infusion equipment for medical use -- Part 9: Fluid lines for use with pressure infusion equipment
95.99
ISO 8536-9:2015
Infusion equipment for medical use -- Part 9: Fluid lines for single use with pressure infusion equipment
60.60
ISO 8536-10:2004 [Withdrawn]
Infusion equipment for medical use -- Part 10: Accessories for fluid lines for use with pressure infusion equipment
95.99
ISO 8536-10:2015
Infusion equipment for medical use -- Part 10: Accessories for fluid lines for single use with pressure infusion equipment
60.60
ISO 8536-11:2004 [Withdrawn]
Infusion equipment for medical use -- Part 11: Infusion filters for use with pressure infusion equipment
95.99
ISO 8536-11:2015
Infusion equipment for medical use -- Part 11: Infusion filters for single use with pressure infusion equipment
60.60
ISO 8536-12:2007
Infusion equipment for medical use -- Part 12: Check valves
90.92
60.60
ISO/WD 8536-12 [Under development]
Infusion equipment for medical use -- Part 12: Check valves
20.20
ISO 8536-13:2016
Infusion equipment for medical use -- Part 13: Graduated flow regulators for single use with fluid contact
60.60
ISO 8536-14:2016
Infusion equipment for medical use -- Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
60.60
ISO 8871:1988 [Withdrawn]
Elastomeric parts for aqueous parenteral preparations
95.99
ISO 8871:1990 [Withdrawn]
Elastomeric parts for aqueous parenteral preparations
95.99
95.99
ISO 8871-1:2003
Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 1: Extractables in aqueous autoclavates
90.93
ISO 8871-2:2003
Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 2: Identification and characterization
90.93
60.60
ISO 8871-3:2003
Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 3: Determination of released-particle count
90.93
ISO 8871-3:2003/PRF Amd 1 [Under development]
50.00
ISO 8871-4:2006
Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 4: Biological requirements and test methods
90.93
ISO 8871-5:2005 [Withdrawn]
Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 5: Functional requirements and testing
95.99
ISO 8871-5:2016
Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 5: Functional requirements and testing
60.60
ISO 8872:1988 [Withdrawn]
Aluminium caps for transfusion, infusion and injection bottles -- General requirements and test methods
95.99
ISO 8872:2003
Aluminium caps for transfusion, infusion and injection bottles -- General requirements and test methods
90.93
ISO 9187-1:1991 [Withdrawn]
Injection equipment for medical use -- Part 1: Ampoules for injectables
95.99
ISO 9187-1:2000 [Withdrawn]
Injection equipment for medical use -- Part 1: Ampoules for injectables
95.99
ISO 9187-1:2006 [Withdrawn]
Injection equipment for medical use -- Part 1: Ampoules for injectables
95.99
ISO 9187-1:2010
Injection equipment for medical use -- Part 1: Ampoules for injectables
90.93
ISO 9187-2:1993 [Withdrawn]
Injection equipment for medical use -- Part 2: One-point-cut (OPC) ampoules
95.99
ISO 9187-2:2010
Injection equipment for medical use -- Part 2: One-point-cut (OPC) ampoules
90.93
ISO 10985:1992 [Withdrawn]
Caps made of aluminium-plastics combinations for infusion bottles and injection vials -- Requirements and test methods
95.99
ISO 10985:1999 [Withdrawn]
Caps made of aluminium-plastics combinations for infusion bottles and injection vials -- Requirements and test methods
95.99
ISO 10985:2009
Caps made of aluminium-plastics combinations for infusion bottles and injection vials -- Requirements and test methods
90.60
ISO 11040-1:1992 [Withdrawn]
Prefilled syringes -- Part 1: Glass cylinders for dental local anaesthetic cartridges
95.99
ISO 11040-1:2015
Prefilled syringes -- Part 1: Glass cylinders for dental local anaesthetic cartridges
60.60
ISO 11040-2:1994 [Withdrawn]
Prefilled syringes -- Part 2: Plungers and discs for dental local anaesthetic cartridges
95.99
ISO 11040-2:2011
Prefilled syringes -- Part 2: Plunger stoppers for dental local anaesthetic cartridges
90.93
ISO 11040-3:1993 [Withdrawn]
Prefilled syringes -- Part 3: Aluminium caps for dental local anaesthetic cartridges
95.99
ISO 11040-3:2012
Prefilled syringes -- Part 3: Seals for dental local anaesthetic cartridges
90.93
ISO 11040-4:1996 [Withdrawn]
Prefilled syringes -- Part 4: Glass barrels for injectables
95.99
ISO 11040-4:2007 [Withdrawn]
Prefilled syringes -- Part 4: Glass barrels for injectables
95.99
ISO 11040-4:2015
Prefilled syringes -- Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
60.60
ISO 11040-5:1996 [Withdrawn]
Prefilled syringes -- Part 5: Plungers for injectables
95.99
ISO 11040-5:2001 [Withdrawn]
Prefilled syringes -- Part 5: Plungers for injectables
95.99
ISO 11040-5:2012
Prefilled syringes -- Part 5: Plunger stoppers for injectables
90.93
ISO 11040-6:2012
Prefilled syringes -- Part 6: Plastic barrels for injectables
90.92
ISO/DIS 11040-6 [Under development]
Prefilled syringes -- Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling
40.20
ISO 11040-7:2015
Prefilled syringes -- Part 7: Packaging systems for sterilized subassembled syringes ready for filling
60.60
ISO 11040-8:2016
Prefilled syringes -- Part 8: Requirements and test methods for finished prefilled syringes
60.60
ISO 11418-1:1996 [Withdrawn]
Containers and accessories for pharmaceutical preparations -- Part 1: Drop-dispensing bottles
95.99
ISO 11418-1:2005 [Withdrawn]
Containers and accessories for pharmaceutical preparations -- Part 1: Drop-dispensing glass bottles
95.99
ISO 11418-1:2016
Containers and accessories for pharmaceutical preparations -- Part 1: Drop-dispensing glass bottles
60.60
ISO 11418-2:1996 [Withdrawn]
Containers and accessories for pharmaceutical preparations -- Part 2: Screw-neck bottles for syrups
95.99
ISO 11418-2:2005 [Withdrawn]
Containers and accessories for pharmaceutical preparations -- Part 2: Screw-neck glass bottles for syrups
95.99
ISO 11418-2:2016
Containers and accessories for pharmaceutical preparations -- Part 2: Screw-neck glass bottles for syrups
60.60
60.60
ISO 11418-3:1996 [Withdrawn]
Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck bottles (veral) for solid and liquid dosage forms
95.99
ISO 11418-3:2005 [Withdrawn]
Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms
95.99
ISO 11418-3:2016
Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms
60.60
60.60
ISO 11418-4:1996 [Withdrawn]
Containers and accessories for pharmaceutical preparations -- Part 4: Tablet bottles
95.99
ISO 11418-4:2005
Containers and accessories for pharmaceutical preparations -- Part 4: Tablet glass bottles
90.93
ISO 11418-5:1997 [Withdrawn]
Containers and accessories for pharmaceutical preparations -- Part 5: Dropper assemblies
95.99
ISO 11418-5:2015
Containers and accessories for pharmaceutical preparations -- Part 5: Dropper assemblies
60.60
ISO 11418-7:1998 [Withdrawn]
Containers and accessories for pharmaceutical preparations -- Part 7: Screw-neck vials made of glass tubing for liquid dosage forms
95.99
ISO 11418-7:2016
Containers and accessories for pharmaceutical preparations -- Part 7: Screw-neck vials made of glass tubing for liquid dosage forms
60.60
ISO 13926-1:1996 [Withdrawn]
Pen systems -- Part 1: Glass cylinders for insulin pen-injectors
95.99
ISO 13926-1:1998 [Withdrawn]
Pen systems -- Part 1: Glass cylinders for pen-injectors for medical use
95.99
ISO 13926-1:2004
Pen systems -- Part 1: Glass cylinders for pen-injectors for medical use
90.92
ISO/DIS 13926-1 [Under development]
Pen systems -- Part 1: Glass cylinders for pen-injectors for medical use
40.00
ISO 13926-2 [Under development]
Pen systems -- Part 2: Plunger stoppers for pen-injectors for medical use
60.00
ISO 13926-2:1999 [Withdrawn]
Pen systems -- Part 2: Plungers and discs for pen-injectors for medical use
95.99
ISO 13926-2:2011
Pen systems -- Part 2: Plunger stoppers for pen-injectors for medical use
90.92
60.60
ISO 13926-3:2012
Pen systems -- Part 3: Seals for pen-injectors for medical use
90.60
ISO 15010:1998
Disposable hanging devices for transfusion and infusion bottles -- Requirements and test methods
90.93
ISO 15137:2005
Self-adhesive hanging devices for infusion bottles and injection vials -- Requirements and test methods
90.60
ISO 15375:2004 [Withdrawn]
Hanging devices for multiple use with infusion bottles -- Requirements and test methods
95.99
ISO 15375:2010
Medical infusion bottles -- Suspension devices for multiple use -- Requirements and test methods
90.93
ISO 15378:2006 [Withdrawn]
Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)
95.99
ISO 15378:2011 [Withdrawn]
Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
95.99
ISO 15378:2015 [Withdrawn]
Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
95.99
ISO 15378:2017
Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
60.60
ISO 15747:2003 [Withdrawn]
Plastics containers for intravenous injection
95.99
ISO 15747:2010
Plastic containers for intravenous injections
90.92
ISO/DIS 15747 [Under development]
Plastic containers for intravenous injections
40.60
ISO 15759:2002 [Withdrawn]
Medical infusion equipment -- Plastics caps with inserted elastomeric liner for containers manufactured by the Blow-Fill-Seal (BFS) process
95.99
ISO 15759:2005
Medical infusion equipment -- Plastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process
90.93
ISO/TR 19727:2017
Medical devices -- Pump tube spallation test -- General procedure
60.60
ISO/CD 21881 [Under development]
Sterile packaging of ready for filling cartridges
30.60
ISO/CD 21882 [Under development]
Sterile packaging of ready for filling vials
30.60
ISO 22413:2007 [Withdrawn]
Transfer sets for pharmaceutical preparations -- Requirements and test methods
95.99
ISO 22413:2010
Transfer sets for pharmaceutical preparations -- Requirements and test methods
90.92
ISO/WD 22413 [Under development]
Transfer sets for pharmaceutical preparations -- Requirements and test methods
20.20
ISO 28620:2010
Medical devices -- Non-electrically driven portable infusion devices
90.92

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