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prEN ISO 18113-5

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2021)

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Alusdokumendid
ISO/DIS 18113-5; prEN ISO 18113-5
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Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
Põhitekst
02.11.2011
Põhitekst
This document specifies requirements for information supplied by the manufacturer of IVD instruments intended for self-testing. This document also applies to apparatus and equipment intended to be used with in vitro diagnostic (IVD) instruments for self-testing. This document can also be applied to accessories. This document does not apply to a) instructions for instrument servicing or repair; b) IVD reagents, including calibrators and control materials for use in control of the reagent; c) IVD instruments for professional use.
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Põhitekst

prEN ISO 18113-1

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO/DIS 18113-1:2021)
Uusim versioon Kavand
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prEN ISO 18113-2

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/DIS 18113-2:2021)
Uusim versioon Kavand
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prEN ISO 18113-3

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021)
Uusim versioon Kavand
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prEN ISO 18113-4

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021)
Uusim versioon Kavand