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SRPS EN 15986:2012

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

Jun 21, 2012

General information

90.93     May 31, 2023

90.00    May 31, 2028

ISS

Z076

European Norm

01.080.20     11.120.01     11.040.01  

English  

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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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Directive 2007/47/EC

Life cycle

NOW

PUBLISHED
SRPS EN 15986:2012
90.93 Standard confirmed
May 31, 2023

Related project

Adopted from EN 15986:2011