SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2011

Publisher

Comitato Elettrotecnico Italiano

Foreword
1 Scope
2 Terms and definitions
3 Requirements for usage
4 Symbol labelling phthalates
Annex A (informative) - Examples of uses of the
        symbol given in this European Standard
Annex B (informative) - Use of the negation symbol
Annex ZA (informative) - Relationship between this
        European Standard and the Essential
        Requirements of EU Directive 93/42/EEC
Bibliography

Describes the requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive 93/42/EEC Section 7.5, 2nd paragraph.

Committee	CT 62
DevelopmentNote	Classificazione CEI 62-231. (12/2011)
DocumentType	Standard
Pages	16
PublisherName	Comitato Elettrotecnico Italiano
Status	Current

Standards	Relationship
UNI CEI EN 15986 : 2011	Identical
EN 15986:2011	Identical

EN 80416-3:2002/A1:2011	BASIC PRINCIPLES FOR GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 3: GUIDELINES FOR THE APPLICATION OF GRAPHICAL SYMBOLS
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
EN 980:2008	Symbols for use in the labelling of medical devices
EN 12264:2005	Health informatics - Categorial structures for systems of concepts

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CEI UNI EN 15986 : 2011

SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

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