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Norm
ÖNORM EN ISO 18113-5
Issue date: 2012 12 01
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments
for self-testing.
This part of ISO 18113 also applies to a...
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Valid
Publisher:
Austrian Standards International
Format:
Digital | 14 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments
for self-testing.
This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for
self-testing.
This part of ISO 18113 can also be applied to accessories.
This part of ISO 18113 does not apply to
a) instructions for instrument servicing or repair,
b) IVD reagents, including calibrators and control materials for use in control of the reagent,
c) IVD instruments for professional use.
ÖNORM EN ISO 18113-5
2012 12 01
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5:...
Norm
↖
ÖNORM EN ISO 18113-5
2010 04 15
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5:...
Norm
ÖNORM EN 592
2002 05 01
Instructions for use for in vitro diagnostic instruments for self-testing
Norm
ÖNORM EN 592
1995 01 01
In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for ...
Norm