NEN EN ISO 8536-2 : 2010
Current
The latest, up-to-date edition.
INFUSION EQUIPMENT FOR MEDICAL USE - PART 2: CLOSURES FOR INFUSION BOTTLES
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
Describes the design, dimensions, material, performance requirements and test of closures for infusion bottles as specified in ISO 8536-1.
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Current
|
| Standards | Relationship |
| ISO 8536-2:2010 | Identical |
| DIN EN ISO 8536-2:2010-08 | Identical |
| EN ISO 8536-2:2010 | Identical |
| NF EN ISO 8536-2 : 2010 | Identical |
| UNE-EN ISO 8536-2:2010 | Identical |
| BS EN ISO 8536-2:2010 | Identical |
| I.S. EN ISO 8536-2:2010 | Identical |