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Norm
ÖNORM EN ISO 18113-2
Issue date: 2024 10 01
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022)
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professiona...
Valid
Publisher:
Austrian Standards International
Format:
Digital | 25 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) reagents, calibrators and controls intended for professional use.
This document can also be applicable to accessories.
This document is applicable to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for self-testing.
ÖNORM EN ISO 18113-2
2024 10 01
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2:...
Norm
↖
ÖNORM EN ISO 18113-2
2012 12 01
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2:...
Norm
ÖNORM EN ISO 18113-2
2010 04 15
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2:...
Norm
ÖNORM EN 375
2001 04 01
Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
Norm
ÖNORM EN 375
1993 03 01
In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for profess...
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
