ISO 15223-1:2016
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document.
ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.
These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this document are not intended to apply to symbols specified in other standards.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Proposal of symbols for adoption
4.2 Requirements for usage
4.3 Other symbols
5 Symbols
Annex A (informative) Examples
Annex B (informative) Use of general prohibition symbol and negation symbol
Bibliography
Previous versions
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Proposal of symbols for adoption
4.2 Requirements for usage
4.3 Other symbols
5 Symbols
Annex A (informative) Examples
Annex B (informative) Use of general prohibition symbol and negation symbol
Bibliography