This 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.
Registration number (WIID)
5101
Scope
This 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.
