ISO/CD TS 16766.2

Тезис

This document provides guidance to manufacturers on the minimal considerations for in vitro diagnostic (IVD) medical devices in a public health crisis: - general considerations; - risk reduction; - monitoring the devices’ post-market performance and quality assurance; - implementing a communication system. This document does not supersede the existing traditional regulatory authorization requirements for IVD medical devices available in the marketplace.

Общая информация

Текущий статус
: В стадии разработки

Этап
: закрытие возможности комментирования [30.60]
Версия
: 1
Технический комитет :
ISO/TC 212

ICS :
11.100.10
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