Тезис

ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document.

ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.

These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this document are not intended to apply to symbols specified in other standards.


Общая информация 

  • Текущий статус
     : Отозвано
    Дата публикации
     : 2016-11
    Исправленный вариант (английский)
     : 2017-03
    Исправленный вариант (Французский)
     : 2017-03
  • Версия
     : 3
  • Технический комитет
     : ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices
  • ICS
     :
    01.080.20 Graphical symbols for use on specific equipment
    11.040.01 Medical equipment in general

Приобретены также другие

  • ISO 13485:2016
    Medical devices
    Quality management systems
    Requirements for regulatory purposes
  • ISO 14971:2019
    Medical devices
    Application of risk management to medical devices
  • ISO 14155:2020
    Clinical investigation of medical devices for human subjects
    Good clinical practice

Жизненный цикл

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  2. Интернет-магазин
  3. Каталог стандартов
  4. МКС
  5. 01
  6. 01.080
  7. 01.080.20
  8. ISO 15223-1:2016