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Norm
ÖNORM EN ISO 18113-5
Issue date: 2024 10 01
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is al...
Valid
Publisher:
Austrian Standards International
Format:
Digital | 23 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.
This document can also be applicable to accessories.
This document 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
2024 10 01
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5:...
Norm
↖
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
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ÖNORM EN 592
1995 01 01
In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for ...
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
