Abstract
PreviewThis document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.
This document can also be applicable 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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Status: PublishedPublication date: 2022-10
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Edition: 2Number of pages: 10
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- ICS :
- 11.100.10 In vitro diagnostic test systems
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| Format | Language | |
|---|---|---|
| std 1 61 | PDF + ePub | |
| std 2 61 | Paper |
- CHF61
Life cycle
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Previously
WithdrawnISO 18113-5:2009
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