EN ISO 22413:2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010)
06-30-2021
02-06-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Design and designation
4 Material
5 Physical requirements
6 Chemical requirements
7 Biological requirements
8 Testing of physical requirements
9 Testing of chemical requirements
10 Testing of biological requirements
11 Packaging
12 Storage
13 Labelling
Annex A (normative) - Testing of fragmentation of transfer
sets with plastic piercing devices
Annex B (normative) - Testing of fragmentation of transfer
sets with metal piercing devices
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EU Directive 93/42/EEC on Medical Devices
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