Standard Swedish standard · SS-EN 15986:2011

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

Status: Valid

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Standard Swedish standard · SS-EN 15986:2011

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

Subjects

For specific equipment (01.080.20) General (11.040.01) General (11.120.01)


Buy this standard

Standard Swedish standard · SS-EN 15986:2011

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
Subscribe on standards - Read more Dölj
Price: 793 SEK
standard ikon pdf

PDF

Price: 793 SEK
standard ikon

Paper

Price: 1 268,80 SEK
standard ikon pdf + standard ikon

PDF + paper

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Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-76941

Edition: 1

Approved: 3/9/2011

No of pages: 24