Instructions for use for in vitro diagnostic instruments for self-testing Ingestion-build-81111 Who is BS EN 12094-1

Who is BS EN 12094-1 – Electrical automatic control and delay devices for

15 Preparation for the assessment session

is intended to be utilised only after a thorough understanding of IEC 61508-1 andIEC 61508-2

"General requirements"

Instructions for use for in vitro diagnostic instruments for self-testing Ingestion-build-81111 Who is BS EN 12094-1BS EN 592: 2002 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 European standard is not applicable to field repair