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60.60 Standard published Feb 22, 2017
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.040.20 Transfusion, infusion and injection equipment
Published
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 provide
a) 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.
Legislation related to this standard
PUBLISHED
EN ISO 1135-3:2017
60.60
Standard published
Feb 22, 2017