SR EN 591:1997

In vitro diagnostic systems. Requirements for user manuals for in vitro diagnostic instruments for professional use

This standard specifies user manuals for in-vitro diagnostic instruments for professional use. User manuals are essential to enable the safe and proper operation of instruments. This standard is not applicable to field repair instructions.

Status : Withdrawn
Approval date : 12/11/1996
Publish date : 12/12/1996
Withdrawal date : 6/24/2003
Number of pages : 14
ICS : 11.100.10 In vitro diagnostic test systems
Technical Committee : 377 - Medical devices

Relations with other standards: