DS/EN 1041:2009 ( Withdrawn )

Information supplied by the manufacturer of medical devices


Status:
Withdrawn
Type:
Standard
Language:
DA;EN
Subject:
Replaced by:
Price from:
€ 96.59
Legislation:

Legislation

Harmonized under:
  • Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices

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

Harmonized standards:
Links

Scope

This standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied.
This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography).
NOTE – When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.


Number of pages: 52

Published: 2009-05-29

Date of approval: 2009-03-27

Date of withdrawal: 2013-10-25

International relationships : EN 1041:2008 IDT

ICS: 11.040.01 - Medical equipment in general 11.120.01 - Pharmaceutics in general 01.110 - Technical product documentation

Item number: M239129


Committees

Committee

  • CENCLC/JTC 3

Danish committee

DS/S-257