BS EN ISO 8536-2:2010
Withdrawn
View Superseded by
Infusion equipment for medical use Closures for infusion bottles
Hardcopy , PDF
English
08-31-2010
02-11-2025
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Withdrawn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 |
| 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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