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ISO 18113-4:2022

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
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ISO 18113-4:2022

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing

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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.

SDO ISO: International Organization for Standardization
Document Number ISO 18113
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 212
Publish Date Document Id Type View
Not Available ISO 18113-4:2022 Revision