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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 2: CLOSURES FOR INFUSION BOTTLES
Hardcopy , PDF
English
01-01-2010
16-02-2023
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.
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Superseded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 |
| 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 |
| BS EN ISO 8536-2:2010 | Identical |
| NS EN ISO 8536-2 : 2010 | Identical |
| DIN EN ISO 8536-2:2010-08 | Identical |
| ISO 8536-2:2010 | Equivalent |
| UNE-EN ISO 8536-2:2010 | Identical |
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