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ISO 18113-4:2009

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

Publication date:   Dec 17, 2009

95.99 Withdrawal of Standard   Oct 6, 2022

General information

95.99 Withdrawal of Standard   Oct 6, 2022

ISO

ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems

International Standard

11.100.10   In vitro diagnostic test systems

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Scope

ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.
ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.
ISO 18113-4:2009 can also be applied to accessories, where appropriate.
ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.

Life cycle

NOW

WITHDRAWN
ISO 18113-4:2009
95.99 Withdrawal of Standard
Oct 6, 2022

REVISED BY

PUBLISHED
ISO 18113-4:2022