Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, French, English

Published date

10-26-2011

Publisher

Asociacion Espanola de Normalizacion

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	CTN 111
DocumentType	Standard
Pages	14
PublisherName	Asociacion Espanola de Normalizacion
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