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EVS-EN 50103:2001

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Staatus: Kehtetu

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Juhised EN 29001, EN 46001, EN 29002 ja EN 46002 standardite rakendamiseks aktiivsete meditsiiniseadmete (sealhulgas aktiivsete implantaatide) tööstuses

The guidelines contained in this European Standard are applicable to a quality system as specified by EN 29001 and EN 46001 or 29002 and EN 46002. This European Standard does not add to, or otherwise change the requirements of those standards, and is not intended to be used directly in the assessment of a supplier's quality system. The guidelines provide concepts and objectives which should be considered by a supplier of active medical devices while developing and maintaining his quality system.

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