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I.S. EN 15986:2011

I.S. 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

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

Defines requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates.

DocumentType
Standard
Pages
15
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
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
IEC 80416-3:2002+AMD1:2011 CSV Basic principles for graphical symbols for use on equipment - Part 3: Guidelines for the application of graphical symbols
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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Hardcopy - English
PDF - English
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