CEN/SS S02 - Transfusion equipment

This document 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 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.

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.

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.

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.

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.

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.

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.

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.

ISO 8536-3:2009 specifies aluminium caps for infusion glass bottles which are in accordance with ISO 8536-1.

This part of ISO 8362 specifies aluminium caps for injection vials as described in ISO 8362-1 and ISO 8362-4.

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.

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.

ISO 8872:2003 specifies general requirements and test methods for aluminium caps for injection vials, and for infusion and transfusion bottles.

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.

2014-03-27 EMA: Draft for // ENQ received in ISO/CS (see notification of 2014-03-26 in dataservice).

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.

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.

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.

This part of ISO 9187 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 this part of ISO 9187 are intended for single use only.

Migrated from Progress Sheet (TC Comment) (2000-07-10): Sweden has made an A-deviation request (see fax upstone) GDJ 1997-10-07 ++ TC letter of 98-04-07 to GDJ:held static bec. overlap between CEN & EPC (TA/9804 ++ 10)

ISO - Taking over of an ISO Technical Corrigendum

CMC - P&P - Mistake on title page

Migrated from Progress Sheet (TC Comment) (2000-07-10): TC letter of 98-04-07 to GDJ:held static bec. overlap between CEN & EPC (TA/9804 ++ 10)

TC - Addition of an A-deviation

TC - Addition of an A-deviation

The issue of the standards  is stopped  due to the necessity to issue a corrigendum taking into account the necessity of a "A deviation" for sweeden. For more details please contact Ludwig Paul at CMC: +32 2 550 08 31.
Expect 2 months delay.

The issue of the standards  is stopped  due to the necessity to issue a corrigendum taking into account the necessity of a "A deviation" for sweeden. For more details please contact Ludwig Paul at CMC: +32 2 550 08 31.
Expect 2 months delay.

Describes test cases for conformance testing of telecontrol equipment, substation automation systems and telecontrol systems, including front-end functions of SCADA. Will facilitate interoperability by providing a standard method of testing protocol implementations. Using this specification during testing is expected to minimize the risk of non-interoperability.

To amend EN ISO 8871 so as to include amendment to ISO 8871 and annex ZB.

Migrated from Progress Sheet (TC Comment) (2000-07-10): Delayed because of need to check with European Pharmacopoeia whether in ++ conflict with certain materials monographs

CMC - P&P - Mistake on title page

CMC - P&P - Mistake on title page

Migrated from Progress Sheet (TC Comment) (2000-07-10): Sweden has made a request to include an A-deviation (see fax Upstone) gdj 1997 ++ -10-07 ++ TC letter of 98-04-07 to GDJ:held static bec. overlap between CEN & EPC (TA/9804 ++ 10)

Migrated from Progress Sheet (TC Comment) (2000-07-10): Sweden has made an A-deviation request (see fax upstone) GDJ 1997-10-07 ++ TC letter of 98-04-07 to GDJ:held static bec. overlap between CEN & EPC (TA/9804 ++ 10)

CMC - P&P - Mistake on title page

Migrated from Progress Sheet (TC Comment) (2000-07-10): Sweden has made an A-deviation request (see fax upstone) gdj 1997-10-07 ++ TC letter of 98-04-07 to GDJ:held static bec. overlap between CEN & EPC (TA/9804 ++ 10)

CMC - P&P - Mistake on title page