SFS-EN ISO 8536-4:2020:en

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Scope

This document specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.

The standards writing body responsible for this document in Finland is Service Sector Employers Palta.

Table of contents

Product group(s)

11.040.20 Transfusion, infusion and injection equipment »

Relationships

Normative references

ISO 14644-1:2015 Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness by particle concentration
ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
ISO 3696:1987 Water for analytical laboratory use -- Specification and test methods

Show normative references associated with publication

Technical committee

CEN/TC 205 Non-active medical devices »

Date of implementation

07.02.2020

Published

11.02.2020

Edition

Pages

Language(s)

English