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Norm
ÖNORM EN 591
Issue date: 2002 03 01
Instructions for use for in vitro diagnostic instruments for professional use
This standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments
including apparatus, equipment, calibrators and con...
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Withdrawn
: 2010 04 15
Publisher:
Austrian Standards International
Format:
Digital | 13 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
This standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments
including apparatus, equipment, calibrators and control materials for professional use, hereafter called IVD instruments.
NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments.
NOTE 2 This standard can also be applied to accessories.
This standard is not applicable to field repair instructions.
ÖNORM EN ISO 18113-3
2012 12 01
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3:...
Norm
ÖNORM EN ISO 18113-3
2010 04 15
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3:...
Norm
ÖNORM EN 591
2002 03 01
Instructions for use for in vitro diagnostic instruments for professional use
Norm
↖
ÖNORM EN 591
1995 01 01
In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for ...
Norm
Norm
ISO 1000:1992
Issue date :
1992 11 12
SI units and recommendations for the use of their multiples and of certain other units
Norm
ÖNORM EN ISO 18113-3
Issue date :
2010 04 15
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)