Reference number
ISO 18113-3:2022
International Standard
ISO 18113-3:2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
Edition 2
2022-10
Preview
ISO 18113-3:2022
79868
недоступно на русском языке
Опубликовано (Версия 2, 2022)

ISO 18113-3:2022

ISO 18113-3:2022
79868
Язык
Формат
CHF 63
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Тезис

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use.

This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.

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 self-testing.

Общая информация

  •  : Опубликовано
     : 2022-10
    : Опубликование международного стандарта [60.60]
  •  : 2
  • ISO/TC 212
    11.100.10 
  • RSS обновления

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