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ISO 18113-5:2009

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing

Publication date:   Dec 9, 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 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.
ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.
ISO 18113-5:2009 can also be applied to accessories.

Life cycle

NOW

WITHDRAWN
ISO 18113-5:2009
95.99 Withdrawal of Standard
Oct 6, 2022

REVISED BY

PUBLISHED
ISO 18113-5:2022