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BS EN ISO 15223-1:2021 – TC:2022 Edition

BS EN ISO 15223-1:2021 – TC:2022 Edition

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

Published By Publication Date Number of Pages
BSI 2022 176
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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
1 30444648
109 A-30387823
110 National foreword
114 European foreword
116 Annex ZA (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
124 Annex ZB (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
133 Foreword
134 Introduction
135 1 Scope
2 Normative references
3 Terms and definitions
141 4 General requirements
4.1 Future symbols
4.2 Requirements for usage
4.3 Other symbols
5 Symbols
162 Annex A (informative) Guidance and examples of symbol use, including multiple symbols
168 Annex B (informative) Use of general prohibition symbol and negation symbol
169 Bibliography

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BS EN ISO 15223-1:2021 - TC
$258.95