I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
Hardcopy , PDF
16-02-2023
English
01-01-2010
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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
Bibliography
Describes the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 8536-2 : 2010 | Identical |
| 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 |
| 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/TS 15510:2003 | Stainless steels Chemical composition |
| ISO 8536-3:2009 | Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles |
| ISO 2230:2002 | Rubber products — Guidelines for storage |
| ISO 3302-1:2014 | Rubber — Tolerances for products — Part 1: Dimensional tolerances |
| ISO 15378:2017 | Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) |
| ISO 3302-2:2008 | Rubber Tolerances for products Part 2: Geometrical tolerances |
| ISO 8871-5:2016 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing |
| 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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