DS/EN 15986:2011

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


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 41.82
Legislation:

Legislation

Harmonized under:
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

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.

Number of pages: 16

Published: 2011-04-14

Date of approval: 2011-04-12

International relationships : EN 15986:2011 IDT

ICS: 01.080.20 - Graphical symbols for use on specific equipment 11.040.01 - Medical equipment in general 11.120.01 - Pharmaceutics in general

Item number: M241020


Committees

Committee

  • CENCLC/JTC 3/WG 1

Danish committee

DS/S-257