BS EN 591:2001
Instructions for use for in vitro diagnostic instruments for professional use
- Standard No.
- BS EN 591:2001
- Release Date
- 2001
- Published By
- British Standards Institution (BSI)
- Status
- 2010-02
- Replace By
- BS EN ISO 18113-3:2009
- Latest
- BS EN ISO 18113-3:2011
- Scope
- This standard 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 standard is not applicable to field repair instructions.
BS EN 591:2001 history
- 2011 BS EN ISO 18113-3:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional use
- 0000 BS EN ISO 18113-3:2009
- 2001 BS EN 591:2001 Instructions for use for in vitro diagnostic instruments for professional use
