|Number of pages||39|
|Committee||Medische hulpmiddelen - horizontale onderwerpen|
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.
|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|