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.
NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.
WITHDRAWN
SRPS EN 592:2008
95.99
Withdrawal of Standard
Jun 28, 2011
WITHDRAWN
SRPS EN ISO 18113-5:2011