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.

  • Standard
    14 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    10 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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.

  • Standard
    20 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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.

  • Standard
    21 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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.

  • Standard
    15 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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.

  • Standard
    14 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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.

  • Standard
    14 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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.

  • Standard
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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.

  • Standard
    16 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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

  • Standard
    12 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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

  • Standard
    6 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Amendment
    8 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    5 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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.

  • Standard
    14 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    10 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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.

  • Standard
    19 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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

  • Standard
    9 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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.

  • Standard
    12 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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

  • Amendment
    8 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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.

  • Standard
    12 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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.

  • Standard
    13 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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.

  • Standard
    9 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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.

  • Standard
    14 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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)

  • Standard
    5 pages
    English language
    sale 10% off
    e-Library read for
    1 day

ISO - Taking over of an ISO Technical Corrigendum

  • Corrigendum
    4 pages
    English, French and German language
    sale 10% off
    e-Library read for
    1 day

CMC - P&P - Mistake on title page

  • Corrigendum
    2 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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)

  • Standard
    7 pages
    English language
    sale 10% off
    e-Library read for
    1 day

TC - Addition of an A-deviation

  • Corrigendum
    3 pages
    English, French and German language
    sale 10% off
    e-Library read for
    1 day

TC - Addition of an A-deviation

  • Corrigendum
    3 pages
    English, French and German language
    sale 10% off
    e-Library read for
    1 day

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.

  • Standard
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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.

  • Standard
    8 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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.

  • Standard
    6 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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

  • Amendment
    7 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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

  • Standard
    18 pages
    English language
    sale 10% off
    e-Library read for
    1 day

CMC - P&P - Mistake on title page

  • Corrigendum
    2 pages
    English language
    sale 10% off
    e-Library read for
    1 day

CMC - P&P - Mistake on title page

  • Corrigendum
    2 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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)

  • Standard
    6 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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)

  • Standard
    7 pages
    English language
    sale 10% off
    e-Library read for
    1 day

CMC - P&P - Mistake on title page

  • Corrigendum
    2 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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)

  • Standard
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day

CMC - P&P - Mistake on title page

  • Corrigendum
    2 pages
    English language
    sale 10% off
    e-Library read for
    1 day