BAS EN 592:2004
Instructions for use for in vitro diagnostic instruments for self-testing
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Status: Withdrawn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 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.
Lifecycle
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Original document and degree of correspondence
- EN 592:2002, identical