EVS-EN 724:1999

Guidance on the application of EN 29001 and 46001 and of EN 29002 and EN 46002 for non-active medical devices

General information
Base Documents
EN 724:1994
Directives or regulations
Standard history
This European Standard provides guidance on the establishment and maintenance of the quality systems specified 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 is not intended to be used for the assessment of a manufacturers quality system. This European 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; and draws attention to aspects of requirements that may not be readily apparent to those unfamiliar with quality systems for non-active medical devices. Annex A to this European Standard provides guidance on the elements of quality systems which are relevant to the manufacture of medical devices which are to be supplied either sterile or at a defined level of microbiological or particulate cleanliness. The adoption of systems other than those described in this European Standard is not to be regarded as a non-compliance with EN 29001 and EN 29002 and/or the specific requirements in EN 46001 and EN 46002.
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