Name: UNI CEI EN 15986 : 2011
Brand: UNI

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

Published date

05-05-2011

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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

This European Standard specifies 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 44
DocumentType	Standard
ProductNote	Italian version of this standard is now available.
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Current

Standards	Relationship
CEI UNI 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
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