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BS EN ISO 15223-1:2021

$198.66

Medical devices. Symbols to be used with information to be supplied by the manufacturer – General requirements

Published By Publication Date Number of Pages
BSI 2021 68
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This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements.

These symbols can be used on the medical device itself, on its packaging or in the accompanying information. The requirements of this document are not intended to apply to symbols specified in other standards.

PDF Catalog

PDF Pages PDF Title
2 National foreword
6 European foreword
8 Annex ZA (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
16 Annex ZB (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
25 Foreword
26 Introduction
27 1 Scope
2 Normative references
3 Terms and definitions
33 4 General requirements
4.1 Future symbols
4.2 Requirements for usage
4.3 Other symbols
5 Symbols
54 Annex A (informative) Guidance and examples of symbol use, including multiple symbols
60 Annex B (informative) Use of general prohibition symbol and negation symbol
61 Bibliography
BS EN ISO 15223-1:2021
$198.66