Reference number
ISO 18113-4:2022
International Standard
ISO 18113-4:2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
Edition 2
2022-10
Preview
ISO 18113-4:2022
79869
недоступно на русском языке
Опубликовано (Версия 2, 2022)

ISO 18113-4:2022

ISO 18113-4:2022
79869
Язык
Формат
CHF 63
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Тезис

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.

This document can also be applicable to accessories.

This document is applicable to the labels for outer and immediate containers and to the instructions for use.

This document does not apply to:

a) IVD instruments or equipment;

b) IVD reagents for professional use.

Общая информация

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

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