EN ISO 1135-3:2017

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.