BS EN ISO 8536-2:2010
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Infusion equipment for medical use Closures for infusion bottles
Hardcopy , PDF
English
31-08-2010
11-02-2025
Foreword
Introduction
1 Scope
2 Normative references
3 Shape and dimensions
4 Designation
5 Material
6 Requirements
7 Labelling
Annex A (normative) - Determination of fragments
Annex B (normative) - Determination of spike penetration
force
Annex C (normative) - Spike retention/sealability
Annex D (normative) - Closure piercing device
Describes the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 99/565171 DC (10/2002) Supersedes 08/30172616 DC. (04/2010)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
This part of ISO8536 specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO8536-1.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this part of ISO8536 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.
| Standards | Relationship |
| ONORM EN ISO 8536-2 : 2010 | Identical |
| ISO 8536-2:2001/Cor 1:2003 | Identical |
| ISO 8536-2:2010 | Identical |
| NEN EN ISO 8536-2 : 2010 | Identical |
| NBN EN ISO 8536-2 : 2010 | Identical |
| NF EN ISO 8536-2 : 2010 | Identical |
| EN ISO 8536-2:2010 | Identical |
| I.S. EN ISO 8536-2:2010 | Identical |
| NS EN ISO 8536-2 : 2010 | Identical |
| DIN EN ISO 8536-2:2010-08 | Identical |
| UNE-EN ISO 8536-2:2010 | Identical |
| ISO 8871-1:2003 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates |
| ISO 7619-1:2010 | Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1: Durometer method (Shore hardness) |
| ISO 8536-3:2009 | Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles |
| ISO 3302-1:2014 | Rubber — Tolerances for products — Part 1: Dimensional tolerances |
| ISO 3302-2:2008 | Rubber — Tolerances for products — Part 2: Geometrical tolerances |
| ISO 48:2010 | Rubber, vulcanized or thermoplastic — Determination of hardness (hardness between 10 IRHD and 100 IRHD) |
| ISO 8871-4:2006 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological requirements and test methods |
| ISO 8536-1:2011 | Infusion equipment for medical use — Part 1: Infusion glass bottles |
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