ISO 18113-5:2022
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ISO 18113-5:2022
79870

Abstract

 Preview

This 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.


General information 

  •  :  Published
     : 2022-10
  •  : 2
     : 10
  •  : ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
  •  :
    11.100.10 In vitro diagnostic test systems

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std 2 58 Paper
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