BS EN 592:2002
Instructions for use for in vitro diagnostic instruments for self-testing
- Standard No.
- BS EN 592:2002
- Release Date
- 2002
- Published By
- British Standards Institution (BSI)
- Status
- 2010-02
- Replace By
- BS EN ISO 18113-5:2009
- Latest
- BS EN ISO 18113-5:2011
- Scope
- This European Standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus and equipment for self-testing which hereafter are called IVD instruments. NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments by lay persons. NOTE 2 This standard can also be applied to accessories. This standard is not applicable to field repair instructions.
BS EN 592:2002 history
- 2011 BS EN ISO 18113-5:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for self-testing
- 0000 BS EN ISO 18113-5:2009
- 2002 BS EN 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing
