ONORM EN ISO 8536-2 : 2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
INFUSION EQUIPMENT FOR MEDICAL USE - PART 2: CLOSURES FOR INFUSION BOTTLES
03-07-2023
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Dimensions and designation
3.1 Dimensions
3.2 Designation
4 Material
5 Physical requirements
5.1 General
5.2 Performance
5.3 Hardness
5.4 Fragmentation
5.5 Spike penetration force
5.6 Sealability and spike retention
5.7 Storage
6 Chemical requirements
7 Biological requirements
8 Sample
9 Marking
10 Conformance
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
Specifies the design, dimensions, material, performance requirements and test of closures for infusion bottles as specified in ISO 8536-1.
| Committee |
TC 179
|
| DocumentType |
Standard
|
| PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 8536-2:2010 | Identical |
| UNE-EN 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 |
| SN EN ISO 8536-2:2010 | Identical |
| BS EN ISO 8536-2:2010 | Identical |
| NS EN ISO 8536-2 : 2010 | Identical |
| DIN EN ISO 8536-2:2010-08 | Identical |
| UNI 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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