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CEI UNI EN 15986 : 2011

Current

Current

The latest, up-to-date edition.

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

€35.72
Excluding VAT

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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