BS EN 15986:2011

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

Published By	Publication Date	Number of Pages
BSI	2011	16

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Categories: 11.040.01 - Medical equipment in general, BSI

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Description

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, 2^nd paragraph. This specifically includes the format of a symbol to be used in the labelling. This European Standard does not specify the requirements for information to be supplied with medical devices, which are addressed by EN 980 and EN 1041.

This European Standard does not specify the requirements of the 1^st and of the 3^rd paragraphs of Essential Requirement 7.5.

Additional information

Status	Confirmed
Pages	16
Publication Date	2011-03-31
ISBN	978 0 580 68260 5
Standard Number	BS EN 15986:2011
Title	Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
Identical National Standard Of	EN 15986:2011
Descriptors	Plasticizers, Symbols, Dangerous materials, Marking, Plastics, Labelling (process), Instructions for use, Phthalates, Graphic symbols, Identification methods, Labels, Medical instruments, Medical equipment
Publisher	BSI
Committee	CH/210/3
ICS Codes	11.040.01 - Medical equipment in general

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BS EN 15986:2011

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