Instructions for use for in vitro diagnostic instruments for professional use
Instructions for use for in vitro diagnostic instruments for professional use
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BS EN 591:2001 specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus, equipment, calibrators and control materials for professional use, hereafter called IVD instruments. NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments. NOTE 2 This standard can also be applied to accessories. This European standard is not applicable to field repair instructions.
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