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Norm
ÖNORM EN 15986
Issue date: 2011 04 15
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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...
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Valid
Publisher:
Austrian Standards International
Format:
Digital | 13 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
Topics
Healthcare, Pharmaceutics, Pharmaceutics in general
Healthcare, Medical equipment, Medical equipment in general
Mechanical engineering foundations & materials, Technical drawing and graphical symbols, Graphical symbols for use on specific equipment
Services & management, Technical drawing and graphical symbols, Graphical symbols for use on specific equipment
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.
ÖNORM EN 15986
2011 04 15
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices c...
Norm
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