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CEN
EN ISO 1135-3:2017

EN ISO 1135-3:2017

Current

Current

The latest, up-to-date edition.

Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)

Published date

22-02-2017

Publisher

Comite Europeen de Normalisation

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European foreword
Foreword
1 Scope
2 Normative references
3 General requirements
4 Materials
5 Physical requirements
6 Chemical requirements
7 Biological requirements
8 Labelling
9 Packaging
10 Disposal
Annex A (normative) - Physical tests
Annex B (normative) - Chemical tests
Annex C (normative) - Biological tests
Bibliography
Annex ZA (informative) - Relationship between this
         European standard and the essential requirements
         of Directive 93/42/EEC [OJ L 169] aimed to be
         covered

ISO 1135-3:2016 specifies requirements for types of blood-taking sets for medical use in order to ensure functional interchangeability of transfusion equipment. It is applicable to sterilized blood-taking sets intended for single use only.ISO 1135-3:2016 also aims to providea) specifications relating to the quality and performance of materials used in transfusion equipment, and b) a unified presentation of terms for such equipment.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-3:2016.

Committee
CEN/TC 205
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

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