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BS ISO 21917:2021

BS ISO 21917:2021

$102.76

Anaesthetic and respiratory equipment. Voice prostheses

Published By Publication Date Number of Pages
BSI 2021 22
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This document specifies performance requirements for voice prostheses including requirements for marking, packaging and information to be provided by the manufacturer as well as test methods for the evaluation of physical characteristics of voice prostheses.

NOTE

There is guidance or rationale for this list item contained in A.2.

PDF Catalog

PDF Pages PDF Title
2 National foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 General requirements
5 Materials
5.1 General
5.2 Biological safety of gas pathways
6 Design requirements
6.1 General requirements
6.2 Valve leakage
11 6.3 Valve opening pressure
6.4 Characteristic curves
7 Requirements for voice prostheses supplied sterile
8 Packaging of voice prostheses supplied sterile
9 Information supplied by the manufacturer
9.1 General requirements
9.2 Marking
12 9.3 Instructions for use
13 Annex A (informative) Rationale
14 Annex B (normative) Test methods

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BS ISO 21917:2021
$102.76