BAS EN 591:2004
Instructions for use for in vitro diagnostic instruments for professional use
General Information
Status: Withdrawn
No. of pages: 14
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 28.12.2004
Technical committee:
Directive:
98/79/EC, In vitro diagnostic medical devices
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Abstract
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.
Lifecycle
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Original document and degree of correspondence
- EN 591:2001, identical