SR EN 592:2003

Instructions for use for in vitro diagnostic instruments for self-testing

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.

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General information

Status : Withdrawn
Approval date : 6/23/2003
Publish date : 6/24/2003
Withdrawal date : 5/31/2010
Number of pages : 14
ICS : 11.100.10 In vitro diagnostic test systems
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN 592:1997
Normative reference SR ISO 1000:1995
Replaced by SR EN ISO 18113-5:2010