EN ISO 1135-3:2017

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

Publication date:   Jun 14, 2017

General information

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

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

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PUBLISHED
EN ISO 1135-3:2017
60.60 Standard published
Feb 22, 2017