Standard

NEN-EN 724:1994 en

Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 426004 for non-active medical devices

  • This norm is withdrawn since 01-07-2005

76,00 82,84 Incl BTW

About norm

Status Withdrawn
Number of pages 39
Committee Medische hulpmiddelen - horizontale onderwerpen
Published on 01-12-1994
Language English
This standard provides guidance on the establishment and maintenance of the Quality Systems defined in EN 29001/EN 46001 or EN 29002/EN 46002 for the manufacture of non-active medical devices. It does not add to, or otherwise change the requirements of those standards and it is not intended to be used for the assessment of a manufacturer's quality system. This standard provides examples of how to meet the requirements, recognising that other methods which achieve the same ends are equally acceptable; gives general advice on how to meet the requirements that may not be readily apparent to those unfamiliar with quality systems for medical devices.

Details

ICS-code 03.120.99
11.040.01
Dutch title Leidraad voor de toepassingen van EN 29001 en EN 46001 en van EN 29002 en EN 46002 voor niet-actieve medische hulpmiddelen
English title Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 426004 for non-active medical devices
Replaced by

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