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Norm
ÖNORM EN ISO 18113-4
Issue date: 2024 10 01
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testi...
Valid
Publisher:
Austrian Standards International
Format:
Digital | 24 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 self-testing.
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 professional use.
ÖNORM EN ISO 18113-4
2024 10 01
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4:...
Norm
↖
ÖNORM EN ISO 18113-4
2012 12 01
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4:...
Norm
ÖNORM EN ISO 18113-4
2010 04 15
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4:...
Norm
ÖNORM EN 376
2002 05 01
Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
Norm
ÖNORM EN 376
1993 03 01
In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-te...
Norm
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Issue date :
2019 12 10
Medical devices — Application of risk management to medical devices
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Issue date :
2021 07 06
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements (Corrected version 2021-07)
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Issue date :
2009 12 09
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
