Standard

SN EN 15986:2011

Jul 2011 Current

Existing or new amendments and versions must be purchased separately.

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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.

Products specifications

Standard from INB
Published: July 1 2011
Effective: July 1 2011
Document type: EN
Pages
ISBN:

ICS: 11.040.01
ICS: 01.080.20
ICS: 11.120.01
Publisher: SNV
Distributor: SNV
National Committee: INB/NK 410

Swiss Federal Authority: SWISSMEDIC
Designated under following Swiss law: 812.213
Designated under following EU law: 93/42/EWG

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Abstract

Products specifications