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SFS-EN ISO 8536-4:2020:en

Infusion equipment for medical use. Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)

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 General Industry Federation.
Table of contents
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
Directive
93/42/EEC Medical devices

http://ec.europa.eu »
Date of implementation
07.02.2020
Published
11.02.2020
Edition
5
Pages
25
Language(s)
English

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