ISO 11195:2018

INTERNATIONAL ISO
STANDARD 11195
Second edition
2018-01
Gas mixers for medical use — Stand-
alone gas mixers
Mélangeurs de gaz à usage médical — Mélangeurs de gaz
indépendants
Reference number
ISO 11195:2018(E)
©
ISO 2018

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ISO 11195:2018(E)

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ii © ISO 2018 – All rights reserved

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ISO 11195:2018(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 *Requirements for essential performance . 3
5 General requirements . 3
5.1 Risk management . 3
5.2 Usability . 3
6 Materials . 3
6.1 Biocompatibility . 3
6.2 Phthalates . 4
6.3 Natural rubber (latex) . 4
6.4 Effects of cleaning, disinfecting or sterilizing agents . 4
6.5 Gas compatibility . 4
6.6 Cleanliness . 5
6.7 Lubricants . 5
7 Normal operating conditions . 5
8 Requirements for gas supply inlet pressure . 5
9 Reverse gas flow .
...