Standard

NS-EN 15986:2011

Jun 2011 Published

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Language English

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Abstract

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. 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 1st and of the 3rd paragraphs of Essential Requirement 7.5.

Document information

Standard from SN
Published: 1 June 2011
Edition: 1
Version: 1
Document type: NAT
ISBN:

ICS 01.080.20
ICS 11.040.01
ICS 11.120.01
National Committee SN/K 113

Legal references

EU law: 93/42/EEC

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Adopted from: EN 15986:2011 , 0

NS-EN 15986:2011

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Abstract

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