ISO/FDIS 24884

недоступно на русском языке

Проект данного международного стандарта находится на этапе утверждения.

Тезис

The proposed new standard provides guidelines on the conditions (means of delivery) and minimum required information which shall be physically delivered, when providing electronic instructions for use (eIFU) for in vitro diagnostic medical devices (IVDs). Not in the scope of this standard: The content of the eIFU as it is covered by ISO 18113-1, -2, -3, -4, -5. This document is applicable to the in vitro diagnostic manufacturers, the developer (investigators), and the users such as medical laboratories. It is also intended to be used by the organizations (e.g. regulatory authorities and conformity assessment bodies), which are responsible for assessing the performance and quality control.

Общая информация

Текущий статус
: В стадии разработки

Этап
: Уведомление направлено в секретариат. Начало голосования по окончательному проекту международного стандарта: 2 мес. [50.20]
Версия
: 1
Технический комитет :
ISO/TC 212

ICS :
11.100.10
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