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BS EN ISO 8536-15:2022+A1:2023

BS EN ISO 8536-15:2022+A1:2023

$102.76

Infusion equipment for medical use – Light-protective infusion sets for single use

Published By Publication Date Number of Pages
BSI 2023 18
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This document specifies the requirements for infusion sets for single use that use light-protective agents in the fluid path materials (henceforth abbreviated as “light-protective infusion sets”). This document also provides guidelines for performance and quality specifications of materials used in light-protective infusion sets.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials
10 6 Physical requirements
6.1 General
6.2 Transparency
6.3 Light-protective performance
6.4 Decolourization
7 Chemical requirements
8 Biological requirements
11 9 Labelling
10 Packaging
11 Disposal
12 Annex A (normative) Determination of light transmittance
14 Annex B (normative) Decolourization test – physical method
15 Annex C (normative) Chemical method for decolourization test – visual colorimetry
16 Bibliography

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BS EN ISO 8536-15:2022+A1:2023
$102.76