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Norm
ÖNORM EN ISO 18113-4
Issue date: 2010 04 15
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents
for self-testing.
This part of ISO 18113 also applies to info...
Withdrawn: 2012 12 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 18 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents
for self-testing.
This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control
materials intended for use with IVD medical devices for self-testing.
This part of ISO 18113 can also be applied to accessories.
This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use.
This part of ISO 18113 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
Norm
Issue date :
2007 02 28
Medical devices — Application of risk management to medical devices (Corrected version 2007-09)
Norm
Issue date :
2012 06 25
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
Norm
Issue date :
2009 12 09
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
Norm
Issue date :
2012 10 15
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
Norm
Issue date :
2019 12 10
Medical devices — Application of risk management to medical devices
Norm
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)
Norm
Issue date :
2009 12 09
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
Norm
Issue date :
2012 12 01
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
Norm
Issue date :
2009 12 17
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
