Instructions for use for in vitro diagnostic instruments for self-testing Ingestion-build-82061 Updated BS EN ISO 9001:2008

Updated BS EN ISO 9001:2008 Quality management systems

but the engineer undertaking the design needs to be aware of those items which will affect the design

3 Normative references

Electrical hazard

Data fields

Instructions for use for in vitro diagnostic instruments for self-testing Ingestion-build-82061 Updated BS EN ISO 9001:2008BS 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