| Name |
Description |
Abstract |
Status |
Publication date |
Edition |
Number of pages |
Technical committee |
ICS |
| ISO 8536-3:2009/Amd 1:2022 |
Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles — Amendment 1 |
|
Published |
2022-06 |
Edition : 3 |
Number of pages : 1 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-1:2003 |
Injection containers and accessories — Part 1: Injection vials made of glass tubing |
ISO 8362-1:2003 specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers shall be made and the performance requirements of those containers.
ISO 8362-1:2003 applies to colourless or amber glass containers made from borosilicate or soda-lime glass, in the form of glass tubing, whether internally surface-treated or not, and intended for use in the packaging, storage or transportation of products intended for injection.
|
Withdrawn |
2003-09 |
Edition : 2 |
Number of pages : 3 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-1:2009 |
Injection containers and accessories — Part 1: Injection vials made of glass tubing |
ISO 8362-1:2009 specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers shall be made and the performance requirements of those containers.
ISO 8362-1:2009 applies to colourless or amber glass containers made from borosilicate or soda-lime glass, made from glass tubing, whether internally surface-treated or not, and intended to be used in the packaging, storage or transportation of products intended for injection.
|
Withdrawn |
2009-12 |
Edition : 3 |
Number of pages : 5 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-1:2009/Amd 1:2015 |
Injection containers and accessories — Part 1: Injection vials made of glass tubing — Amendment 1 |
|
Withdrawn |
2015-12 |
Edition : 3 |
Number of pages : 2 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-1:2018 |
Injection containers and accessories — Part 1: Injection vials made of glass tubing |
This document specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance requirements of those containers.
This document is applicable to colourless or amber glass containers made from borosilicate or soda-lime glass, made from glass tubing, whether internally surface-treated or not, and intended to be used in the packaging, storage or transportation of products intended for injection.
|
Published |
2018-08 |
Edition : 4 |
Number of pages : 7 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-2:1988 |
Injection containers for injectables and accessories — Part 2: Closures for injection vials |
Specifies the design, dimensions, material, performance, requirements and tests for single-use closures for injection vials covered by ISO 8362-1 and ISO 8362-4. The three normative annexes contain test methods for the penetrability by means of a needle and the subsequent self-healing of the closures.
|
Withdrawn |
1988-12 |
Edition : 1 |
Number of pages : 8 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-2:2008 |
Injection containers and accessories — Part 2: Closures for injection vials |
ISO 8362-2:2008 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in ISO 8362-2:2008 are intended for single use only.
|
Withdrawn |
2008-10 |
Edition : 2 |
Number of pages : 5 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-2:2015 |
Injection containers and accessories — Part 2: Closures for injection vials |
ISO 8362-2:2015 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362‑1 and ISO 8362‑4.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in ISO 8362-2:2015 are intended for single use only.
|
Published |
2015-10 |
Edition : 3 |
Number of pages : 6 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-2:2015/Amd 1:2022 |
Injection containers and accessories — Part 2: Closures for injection vials — Amendment 1 |
|
Published |
2022-08 |
Edition : 3 |
Number of pages : 2 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-3:1989 |
Injection containers for injectables and accessories — Part 3: Aluminium caps for injection vials |
Specifies the dimensions, designations and requirements of aluminium caps. These caps are not considered as being made of primary packaging materials for direct contact with the pharmaceutical preparations.
|
Withdrawn |
1989-11 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-3:2001 |
Injection containers and accessories — Part 3: Aluminium caps for injection vials |
This part of ISO 8362 specifies aluminium caps for injection vials as described in ISO 8362-1 and ISO 8362-4.
|
Published |
2001-12 |
Edition : 2 |
Number of pages : 3 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-4:1987 |
Infusion equipment for medical use — Part 4: Infusion sets for single use |
|
Withdrawn |
1987-11 |
Edition : 1 |
Number of pages : 10 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-4:2003 |
Injection containers and accessories — Part 4: Injection vials made of moulded glass |
ISO 8362-4:2003 specifies the shape, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers shall be made and the performance requirements for the containers.
It applies to colourless or amber glass containers moulded from borosilicate or soda-lime glass, with or without an internal surface treatment, and intended to be used in the packaging, storage or transportation of products intended for injection.
|
Withdrawn |
2003-08 |
Edition : 2 |
Number of pages : 6 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-4:2011 |
Injection containers and accessories — Part 4: Injection vials made of moulded glass |
ISO 8362-4:2011 specifies the shape, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance requirements for the containers.
ISO 8362-4:2011 applies to colourless or amber glass containers moulded from borosilicate or soda-lime glass, with or without an internal surface treatment, and intended to be used in the packaging, storage or transportation of products intended for injection.
|
Published |
2011-09 |
Edition : 3 |
Number of pages : 7 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-5:1995 |
Injection containers for injectables and accessories — Part 5: Freeze drying closures for injection vials |
Describes the design, dimensions, materials, performance and test for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which is used at the freeze drying (or lyophilization) of drugs and biological materials.
|
Withdrawn |
1995-12 |
Edition : 1 |
Number of pages : 11 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-5:2008 |
Injection containers and accessories — Part 5: Freeze drying closures for injection vials |
ISO 8362-5:2008 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials.
Closures specified in ISO 8362-5:2008 are intended for single use only.
|
Withdrawn |
2008-10 |
Edition : 2 |
Number of pages : 9 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-5:2016 |
Injection containers and accessories — Part 5: Freeze drying closures for injection vials |
ISO 8362-5:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362‑1 and ISO 8362‑4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this part of ISO 8362 are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.
|
Published |
2016-02 |
Edition : 3 |
Number of pages : 9 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-6:1992 |
Injection containers for injectables and accessories — Part 6: Caps made of aluminium-plastics combinations for injection vials |
Specifies classification of types, dimensions and tolerances, designation, requirements, packaging, and marking.
|
Withdrawn |
1992-09 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-6:2010 |
Injection containers and accessories — Part 6: Caps made of aluminium-plastics combinations for injection vials |
ISO 8362‑6:2010 specifies caps made of aluminium-plastics combinations for injection vials as specified in ISO 8362‑1 and ISO 8362‑4.
|
Published |
2010-06 |
Edition : 2 |
Number of pages : 3 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-7:1995 |
Injection containers for injectables and accessories — Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part |
Relates to aluminium-plastics combinations for the injection caps of injection vials where the plastics part does not overlap the diameter of the vial body.
|
Withdrawn |
1995-10 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8362-7:2006 |
Injection containers and accessories — Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part |
ISO 8362-7:2006 specifies aluminium-plastics combinations for the injection caps of injection vials, as specified in ISO 8362-1 and ISO 8362-4, where the plastics part does not overlap the diameter of the vial body.
|
Published |
2006-04 |
Edition : 2 |
Number of pages : 4 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-4:1998 |
Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed |
|
Withdrawn |
1998-02 |
Edition : 2 |
Number of pages : 20 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 6845:1982 |
Surface active agents — Technical alkane sulphonates — Determination of mean relative molecular mass of alkane monosulphonates |
|
Withdrawn |
1982-12 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
71.100.40
Surface active agents
|
| ISO/CD 8417 |
Risk management of particulate contamination for devices with intravascular access |
This document applies to medical devices that are used to provide intravascular access to patients to deliver liquids. It
- addresses the related clinical risks
- gives further advice on the determination and acceptability assessment of particulate loads as amendment to the existing clauses in ISO 8536-4
- gives advice on how to perform a comprehensive risk analysis on potential particle sources and how to mitigate related risks in design, manufacturing, and application of the devices
|
Under development |
|
Edition : 1 |
|
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-1:1991 |
Infusion equipment for medical use — Part 1: Infusion glass bottles |
|
Withdrawn |
1991-08 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-1:2000 |
Infusion equipment for medical use — Part 1: Infusion glass bottles |
|
Withdrawn |
2000-06 |
Edition : 2 |
Number of pages : 5 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-1:2000/Amd 1:2004 |
Infusion equipment for medical use — Part 1: Infusion glass bottles — Amendment 1 |
|
Withdrawn |
2004-09 |
Edition : 2 |
Number of pages : 2 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-1:2006 |
Infusion equipment for medical use — Part 1: Infusion glass bottles |
ISO 8536-1:2006 specifies the dimensions, performance and requirements of infusion glass bottles necessary to ensure functional interchangeability. It is applicable only to infusion bottles for single use.
|
Withdrawn |
2006-03 |
Edition : 3 |
Number of pages : 6 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-1:2011 |
Infusion equipment for medical use — Part 1: Infusion glass bottles |
ISO 8536-1:2011 specifies the dimensions, performance and requirements of infusion glass bottles necessary to ensure functional interchangeability. It is applicable only to infusion bottles for single use.
|
Published |
2011-09 |
Edition : 4 |
Number of pages : 7 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-2:1992 |
Infusion equipment for medical use — Part 2: Closures for infusion bottles |
|
Withdrawn |
1992-09 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-2:2001 |
Infusion equipment for medical use — Part 2: Closures for infusion bottles |
|
Withdrawn |
2001-06 |
Edition : 2 |
Number of pages : 10 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-2:2001/Cor 1:2003 |
Infusion equipment for medical use — Part 2: Closures for infusion bottles — Technical Corrigendum 1 |
|
Withdrawn |
2003-02 |
Edition : 2 |
Number of pages : 2 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-2:2010 |
Infusion equipment for medical use — Part 2: Closures for infusion bottles |
ISO 8536‑2:2010 specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in ISO 8536‑2:2010 are intended for single use only.
|
Withdrawn |
2010-03 |
Edition : 3 |
Number of pages : 11 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-2:2023 |
Infusion equipment for medical use — Part 2: Closures for infusion bottles |
This document specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this document are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
|
Published |
2023-01 |
Edition : 4 |
Number of pages : 12 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-3:1992 |
Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles |
|
Withdrawn |
1992-06 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-3:1999 |
Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles |
|
Withdrawn |
1999-09 |
Edition : 2 |
Number of pages : 5 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-3:2009 |
Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles |
ISO 8536-3:2009 specifies aluminium caps for infusion glass bottles which are in accordance with ISO 8536-1.
|
Published |
2009-06 |
Edition : 3 |
Number of pages : 5 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-4:2004 |
Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed |
ISO 8536-4:2004 specifies requirements for single-use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
Secondary aims of this part of ISO 8536 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.
|
Withdrawn |
2004-08 |
Edition : 3 |
Number of pages : 17 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-4:2007 |
Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed |
ISO 8536-4:2007 specifies requirements for single-use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
Secondary aims of ISO 8536-4:2007 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-4:2007.
|
Withdrawn |
2007-04 |
Edition : 4 |
Number of pages : 17 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-4:2010 |
Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed |
ISO 8536‑4:2010 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
Secondary aims of ISO 8536‑4:2010 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536‑4:2010.
|
Withdrawn |
2010-10 |
Edition : 5 |
Number of pages : 17 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-4:2010/Amd 1:2013 |
Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed — Amendment 1 |
|
Withdrawn |
2013-03 |
Edition : 5 |
Number of pages : 3 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-4:2019 |
Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed |
This document specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.
|
Published |
2019-09 |
Edition : 6 |
Number of pages : 18 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-5:1992 |
Infusion equipment for medical use — Part 5: Burette type infusion sets |
Specifies requirements for sterilized burette sets of 50 ml, 100 ml and 150 ml nominal capacity intended for single use.
|
Withdrawn |
1992-01 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-5:2004 |
Infusion equipment for medical use — Part 5: Burette infusion sets for single use, gravity feed |
ISO 8536-5:2004 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment.
ISO 8536-5:2004 also provides guidance on specifications relating to the quality and performance of materials.
In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-5:2004.
|
Published |
2004-02 |
Edition : 2 |
Number of pages : 5 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-6:1995 |
Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles |
Specifies the design, dimensions, material, performance, requirements and test for the type of closure for infusion bottles, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials.
|
Withdrawn |
1995-04 |
Edition : 1 |
Number of pages : 14 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-6:2009 |
Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles |
ISO 8536-6:2009 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, which are used in connection with the freeze-drying (or lyophilization) of drugs and biological materials.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in ISO 8536-6:2009 are intended for single use only.
|
Withdrawn |
2009-11 |
Edition : 2 |
Number of pages : 15 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 3004-2:1989 |
Light gauge metal containers — Capacities and related cross-sections — Part 2: Open-top cans for meat and products containing meat for human consumption |
|
Withdrawn |
1989-06 |
Edition : 2 |
Number of pages : 3 |
Technical Committee |
55.120
Cans. Tins. Tubes
|
| ISO 8536-6:2016 |
Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles |
ISO 8536-6:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this document are intended for single use only.
|
Published |
2016-12 |
Edition : 3 |
Number of pages : 16 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-6:2016/WD Amd 1 |
Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles — Amendment 1 |
|
Deleted |
|
Edition : 3 |
|
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-7:1992 |
Infusion equipment for medical use — Part 7: Caps made of aluminium-plastics combinations for infusion bottles |
|
Withdrawn |
1992-09 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-7:1999 |
Infusion equipment for medical use — Part 7: Caps made of aluminium-plastics combinations for infusion bottles |
|
Withdrawn |
1999-09 |
Edition : 2 |
Number of pages : 3 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-7:2009 |
Infusion equipment for medical use — Part 7: Caps made of aluminium-plastics combinations for infusion bottles |
ISO 8536-7:2009 specifies caps made of aluminium-plastics combinations intended for use on infusion glass bottles which are in accordance with ISO 8536-1.
|
Published |
2009-01 |
Edition : 3 |
Number of pages : 3 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-8:2004 |
Infusion equipment for medical use — Part 8: Infusion equipment for use with pressure infusion apparatus |
ISO 8536-8:2004 applies to sterilized infusion sets for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).
|
Withdrawn |
2004-08 |
Edition : 1 |
Number of pages : 11 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-8:2015 |
Infusion equipment for medical use — Part 8: Infusion sets for single use with pressure infusion apparatus |
ISO 8536-8:2015 gives users information on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar).
|
Published |
2015-06 |
Edition : 2 |
Number of pages : 13 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-9:2004 |
Infusion equipment for medical use — Part 9: Fluid lines for use with pressure infusion equipment |
ISO 8536:2004 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).
The following items are covered by ISO 8536:2004:
syringe pump lines (SPL);connecting lines (CL); andlines with integrated injection cannula (LIC).
|
Withdrawn |
2004-10 |
Edition : 1 |
Number of pages : 8 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-9:2015 |
Infusion equipment for medical use — Part 9: Fluid lines for single use with pressure infusion equipment |
ISO 8536-9:2015 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).
The following items are covered by ISO 8536-9:2015:
a) syringe pump lines (SPL);
b) connecting lines (CL);
c) lines with integrated injection cannula (LIC).
|
Published |
2015-06 |
Edition : 2 |
Number of pages : 11 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-10:2004 |
Infusion equipment for medical use — Part 10: Accessories for fluid lines for use with pressure infusion equipment |
ISO 8536-10:2004 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8.
ISO 8536-10:2004 includes:
Two-way stopcocks (2SC), three-way stopcocks (3SC), four-way stopcocks (4SC) and stopcocks manifold (SM). Designation of a stopcock depends on the number of connections. The number of possible functional positions can be expressed by addition of a complementary note, using a diagonal stroke and a numeral indicating the number of possible stopcock positions, e.g. 3/4-way stopcock for three-way stopcock with four possible positions.Units with injection site (UIS) or check valve (UCV).Stoppers (S) or adapters (A).
|
Withdrawn |
2004-10 |
Edition : 1 |
Number of pages : 10 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-10:2015 |
Infusion equipment for medical use — Part 10: Accessories for fluid lines for single use with pressure infusion equipment |
ISO 8536-10:2015 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8.
ISO 8536-10:2015 includes the following:
a) two-way stopcocks, three-way stopcocks, four-way stopcocks, and stopcocks manifold;
b) units with injection site or check valve;
c) stoppers or adapters.
|
Published |
2015-06 |
Edition : 2 |
Number of pages : 8 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 3004-3:1981 |
Hermetically sealed metal containers for food and drinks — Part 3: Cans for drinks |
|
Withdrawn |
1981-04 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
55.120
Cans. Tins. Tubes
|
| ISO 8536-11:2015 |
Infusion equipment for medical use — Part 11: Infusion filters for single use with pressure infusion equipment |
ISO 8536-11:2015 applies to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536‑8. It does not include the effectiveness of filters for separation of particles or germs.
|
Published |
2015-06 |
Edition : 2 |
Number of pages : 8 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-12:2007 |
Infusion equipment for medical use — Part 12: Check valves |
ISO 8536-12:2007 applies to sterilized check valves intended for single use and used with infusion equipment for gravity-feed infusion and/or with pressure infusion apparatus.
|
Withdrawn |
2007-04 |
Edition : 1 |
Number of pages : 7 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-12:2007/Amd 1:2012 |
Infusion equipment for medical use — Part 12: Check valves — Amendment 1 |
|
Withdrawn |
2012-10 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-12:2021 |
Infusion equipment for medical use — Part 12: Check valves for single use |
This document specifies requirements for check valves intended for single use and used with infusion equipment both with gravity-feed infusion and with pressure infusion apparatus.
The functional requirements in this document also apply to inline check valves.
|
Published |
2021-02 |
Edition : 2 |
Number of pages : 11 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-13:2016 |
Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact |
ISO 8536-13:2016 specifies requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with fluid contact under gravity feed conditions.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-13:2016.
|
Published |
2016-10 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-14:2016 |
Infusion equipment for medical use — Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact |
ISO 8536-14:2016 specifies requirements for non-sterile clamps and flow regulators used as a subcomponent to control the flow of intravenous solutions and/or blood components through sterilized infusion and blood transfusion sets and blood bag assemblies without fluid contact.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-14:2016.
|
Published |
2016-11 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-15:2022 |
Infusion equipment for medical use — Part 15: Light-protective infusion sets for single use |
This document specifies the requirements for infusion sets for single use that use light-protective agents in the fluid path materials (henceforth abbreviated as "light-protective infusion sets”).
This document also provides guidelines for performance and quality specifications of materials used in light-protective infusion sets.
|
Published |
2022-03 |
Edition : 1 |
Number of pages : 8 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8536-15:2022/Amd 1:2023 |
Infusion equipment for medical use — Part 15: Light-protective infusion sets for single use — Amendment 1 |
|
Published |
2023-03 |
Edition : 1 |
Number of pages : 1 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8871-1:2003 |
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates |
ISO 8871-1:2003 defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use.
It specifies a series of comparative test methods for chemical evaluation by the determination of extractables in aqueous autoclavates and describes the various fields of application for elastomeric parts. Dimensions and functional characteristics are specified in the relevant International Standards. Required properties as specified in this part of ISO 8871 are regarded as minimum requirements.
Elastomeric parts for empty syringes for single use are excluded from the scope of this part of ISO 8871 as they are not in contact with the injected preparation for a significant length of time.
Compatibility studies with the intended preparation have to be performed before the approval for final use can be given; however, this part of ISO 8871 does not specify procedures for carrying out compatibility studies.
|
Published |
2003-10 |
Edition : 1 |
Number of pages : 19 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8872:1988 |
Aluminium caps for transfusion, infusion and injection bottles — General requirements and test methods |
In opposition to vials and the elastomeric parts the caps are not considered as primary packaging materials that will come into direct contact with pharmaceutical preparations or blood. Thus, the tests are mainly related to their mechanical protection characteristics.
|
Withdrawn |
1988-12 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8871-2:2003 |
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization |
ISO 8871-2:2003 specifies evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies. The physical and chemical test procedures specified in this part of ISO 8871 permit the determination of the typical characteristics of rubber materials, and may serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate set of tests is selected, depending upon the type of rubber and its application.
This part of ISO 8871 does not specify other requirements for rubber materials. These are laid down in the relevant product standards.
|
Withdrawn |
2003-10 |
Edition : 1 |
Number of pages : 20 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8871-2:2003/Amd 1:2005 |
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization — Amendment 1 |
|
Withdrawn |
2005-07 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8871-2:2020 |
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization |
This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices.
The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts including coatings and surface treatments and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.
|
Published |
2020-05 |
Edition : 2 |
Number of pages : 23 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8871-3:2003 |
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 3: Determination of released-particle count |
Elastomeric closures may be superficially contaminated with visible and subvisible particles, and fragments can also be produced when the closure is pierced by a needle.
Such particles may be transferred to pharmaceutical preparations in contact with the elastomeric parts and affect the quality of such preparations.
ISO 8871-3:2003 specifies methods for the determination of the number of visible and subvisible particles, respectively, detached from elastomeric parts by rinsing.
It does not specify particle contamination limits. These will have to be agreed upon between manufacturer and user.
|
Published |
2003-08 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8871-3:2003/Amd 1:2018 |
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 3: Determination of released-particle count — Amendment 1 |
|
Published |
2018-01 |
Edition : 1 |
Number of pages : 1 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| 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 specifies biological requirements for elastomeric parts for parenterals and for devices for pharmaceutical use. It also specifies the test methods, i.e. it offers the extraction procedures for elastomeric parts, and it makes reference to relevant biological test instructions in Pharmacopoeias and standards.
|
Published |
2006-06 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8871-5:2005 |
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing |
ISO 8871-5:2005 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.
|
Withdrawn |
2005-08 |
Edition : 1 |
Number of pages : 10 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8871-5:2016 |
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing |
ISO 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.
NOTE Functional testing with spikes is specified in ISO 8536‑2 and in ISO 8536‑6.
|
Published |
2016-10 |
Edition : 2 |
Number of pages : 10 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8871:1988 |
Elastomeric parts for aqueous parenteral preparations |
|
Withdrawn |
1988-11 |
Edition : 1 |
|
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8871:1990 |
Elastomeric parts for aqueous parenteral preparations |
The elastomeric parts generally called "rubber" may vary considerably in their composition with regard to fillers, softeners, pigments and other auxiliary ingredients. This standard defines procedures for identifying and classifying elastomeric parts for primary packs and medical devices used in direct contact with the preparations. To avoid any affection of the preparations the 12 normative annexes specify test methods for individual applications.
|
Withdrawn |
1990-08 |
Edition : 2 |
Number of pages : 15 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 8872:2022 |
Aluminium caps and aluminium/plastic caps for infusion bottles and injection vials — General requirements and test methods |
This document specifies general requirements and test methods for aluminium caps and aluminium/plastic caps intended for use on infusion bottles and/or injection vials.
|
Published |
2022-11 |
Edition : 3 |
Number of pages : 13 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 9187-1:1991 |
Injection equipment for medical use — Part 1: Ampoules for injectables |
|
Withdrawn |
1991-06 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 9187-1:2000 |
Injection equipment for medical use — Part 1: Ampoules for injectables |
|
Withdrawn |
2000-05 |
Edition : 2 |
Number of pages : 7 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 9187-1:2006 |
Injection equipment for medical use — Part 1: Ampoules for injectables |
ISO 9187-1:2006 specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products.
It is applicable to ampoules with and without a colour break-ring.
The provision of ampoules with a colour break-ring, and the choice of colour of the break-ring, is subject to agreement between the manufacturer and user.
Ampoules complying with ISO 9187-1:2006 are intended for single use only.
|
Withdrawn |
2006-04 |
Edition : 3 |
Number of pages : 7 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 9187-1:2010 |
Injection equipment for medical use — Part 1: Ampoules for injectables |
ISO 9187-1:2010 specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products.
ISO 9187-1:2010 is applicable to ampoules with and without a colour break-ring; the provision of ampoules with a colour break-ring, and the choice of colour of the break-ring, is subject to agreement between the manufacturer and user.
Ampoules complying with ISO 9187-1:2010 are intended for single use only.
|
Published |
2010-10 |
Edition : 4 |
Number of pages : 9 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 9187-2:1993 |
Injection equipment for medical use — Part 2: One-point-cut (OPC) ampoules |
Specifies materials, dimensions and requirements (hydrolytic resistance, annealing quality, breaking force, position and stability of point, delivery, packaging, marking) for forms of one-point-cut ampoules (forms B, C and D) for injectables. Ampoules complying with this part of the standard are intended for single use only.
|
Withdrawn |
1993-06 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 9187-2:2010 |
Injection equipment for medical use — Part 2: One-point-cut (OPC) ampoules |
ISO 9187-2:2010 specifies materials, dimensions and requirements for forms of one-point-cut (OPC) ampoules (forms B, C and D) for injectables.
Ampoules complying with ISO 9187-2:2010 are intended for single use only.
|
Published |
2010-10 |
Edition : 2 |
Number of pages : 4 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 9997:1990 |
Dental cartridge syringes |
|
Withdrawn |
1990-10 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
;
11.060.20
Dental equipment
|
| ISO 10985:1992 |
Caps made of aluminium-plastics combinations for infusion bottles and injection vials — Requirements and test methods |
|
Withdrawn |
1992-09 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 10985:1999 |
Caps made of aluminium-plastics combinations for infusion bottles and injection vials — Requirements and test methods |
|
Withdrawn |
1999-09 |
Edition : 2 |
Number of pages : 4 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 10985:2009 |
Caps made of aluminium-plastics combinations for infusion bottles and injection vials — Requirements and test methods |
ISO 10985:2009 specifies general requirements and test methods for caps made of aluminium-plastics combinations in accordance with ISO 8536-7 or ISO 8362-6 intended for use respectively on infusion bottles as specified in ISO 8536-1 and/or injection bottles as specified in ISO 8362-1 and ISO 8362-4.
The purpose of ISO 10985:2009 is to specify caps that provide:
guarantee of originality of the closure up to the point of administration;
compression of the sealing element (rubber closure) on to the sealing surfaces of the infusion and/or injection bottles;
protection of the sealing element against soiling and mechanical damage;
simple and injury-free opening of the closure in order to expose the penetration area of the rubber closure and/or to permit total removal of the cap.
|
Withdrawn |
2009-02 |
Edition : 3 |
Number of pages : 4 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
|
| ISO 3004-3:1986 |
Light gauge metal containers — Capacities and related cross-sections — Part 3: Open-top cans for drinks |
|
Withdrawn |
1986-10 |
Edition : 2 |
Number of pages : 3 |
Technical Committee |
55.120
Cans. Tins. Tubes
|
| ISO 11418-1:1996 |
Containers and accessories for pharmaceutical preparations — Part 1: Drop-dispensing bottles |
Specifies the design, dimensions, materials and requirements of drop-dispensing bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.
|
Withdrawn |
1996-02 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
;
11.120.99
Other standards related to pharmaceutics
|
| ISO 11418-1:2005 |
Containers and accessories for pharmaceutical preparations — Part 1: Drop-dispensing glass bottles |
ISO 11418-1:2005 specifies the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug.
ISO 11418-1:2005 is applicable to drop-dispensing glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.
|
Withdrawn |
2005-02 |
Edition : 2 |
Number of pages : 4 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
;
11.120.99
Other standards related to pharmaceutics
|
| ISO 11418-1:2016 |
Containers and accessories for pharmaceutical preparations — Part 1: Drop-dispensing glass bottles |
ISO 11418-1:2016 specifies the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug.
It is applicable to drop-dispensing glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.
|
Published |
2016-11 |
Edition : 3 |
Number of pages : 4 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
;
11.120.99
Other standards related to pharmaceutics
|
| ISO 11418-2:1996 |
Containers and accessories for pharmaceutical preparations — Part 2: Screw-neck bottles for syrups |
Specifies the design, dimensions, materials and requirements of screw-neck bottles used for pharmaceutical preparations in liquid form (sirups). Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.
|
Withdrawn |
1996-02 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
;
11.120.99
Other standards related to pharmaceutics
|
| ISO 11418-2:2005 |
Containers and accessories for pharmaceutical preparations — Part 2: Screw-neck glass bottles for syrups |
ISO 11418-2:2005 specifies the design, dimensions, material and requirements of screw-neck glass bottles for pharmaceutical preparations in liquid form (syrups). Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug.
ISO 11418-2:2005 is applicable to screw-neck glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.
|
Withdrawn |
2005-02 |
Edition : 2 |
Number of pages : 4 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
;
11.120.99
Other standards related to pharmaceutics
|
| ISO 11418-2:2016 |
Containers and accessories for pharmaceutical preparations — Part 2: Screw-neck glass bottles for syrups |
ISO 11418-2:2016 specifies the design, dimensions, material and requirements of screw-neck glass bottles for pharmaceutical preparations in liquid form (syrups). Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug.
It is applicable to screw-neck glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.
|
Published |
2016-11 |
Edition : 3 |
Number of pages : 6 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
;
11.120.99
Other standards related to pharmaceutics
|
| ISO 11418-2:2016/Amd 1:2017 |
Containers and accessories for pharmaceutical preparations — Part 2: Screw-neck glass bottles for syrups — Amendment 1 |
|
Published |
2017-11 |
Edition : 3 |
Number of pages : 1 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
;
11.120.99
Other standards related to pharmaceutics
|
| ISO 11418-3:1996 |
Containers and accessories for pharmaceutical preparations — Part 3: Screw-neck bottles (veral) for solid and liquid dosage forms |
Specifies the design, dimensions, materials and requirements of screw-neck bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of solid and liquid pharmaceutical preparations which are not intended for parenteral use.
|
Withdrawn |
1996-02 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.20
Transfusion, infusion and injection equipment
;
11.120.99
Other standards related to pharmaceutics
|
| ISO 3004-4:1980 |
Hermetically sealed metal containers for food and drinks — Part 4: Cans for edible oil |
|
Withdrawn |
1980-09 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
55.120
Cans. Tins. Tubes
|