SR EN 591:2003

Instructions for use for in vitro diagnostic instruments for professional use

This standard specifies the requirements for the contents of user manuals for in vitro diagnostic instruments including apparatus and equipment for professional use, hereafter called instruments. Note 1: User manuals are essential to enable the safe and proper operation of instruments. 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Status : Withdrawn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 : 6/24/2003
Publish date : 6/25/2003
Withdrawal date : 5/31/2010
Number of pages : 16
ICS : 11.100 Laboratory medicine
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN 591:1997
Normative reference SR EN 375:2003
Normative reference SR ISO 1000:1995
Replaced by SR EN ISO 18113-3:2010