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Norm
ÖNORM EN ISO 18113-4
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)
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...
Valid
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 17 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 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
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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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements