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Standard

NS-EN 1041:1998

Withdrawn

Note: This standard has a new edition: NS-EN 1041:2008+A1:2013

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Abstract

This standard specifies requirements on information to be supplied by a manufacturer for different categories of medical devices, as required by the relevant EU Directives. It does not specify the language to be used for such information. It is intended to complement the specific requirements of the EU Directives on medical devices in the context of specifying means by which certain requirements can be met. If these means are followed by a manufacturer, they will provide presumption of conformity with the relevant essential requirements regarding information to be supplied.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 1
  • Version: 1
  • Document type: NAT
  • Pages
  • ICS 01.110
  • ICS 11.040.01
  • ICS 11.120.01
  • National Committee CEN/TC 257/WG 2

Legal references

EU law:
Law referenceRestrictions
90/385/EEC
93/42/EEC

Product Relations

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