ISO 18113-5:2022

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.

Текущий статус
: Опубликовано

Дата публикации
: 2022-10
Версия
: 2
Технический комитет
: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
ICS
:
11.100.10 In vitro diagnostic test systems

	Формат	Язык
std 1 61	PDF + ePub
std 2 61	Бумажный

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