Ссылочный номер
ISO/TR 15499:2016
Технический отчет
ISO/TR 15499:2016
Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
Версия 2
2016-12
В время отменен
ISO/TR 15499:2016
69217
Отозвано (Версия 2, 2016)

Тезис

ISO/TR 15499:2016 is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993‑1. It does not add to, or otherwise change, the requirements of ISO 10993‑1. This document does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.

This guidance is applicable to all biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.

Общая информация

  •  : Отозвано
     : 2016-12
    : Отмена международного стандарта [95.99]
  •  : 2
  • ISO/TC 194
    11.100.20 
  • RSS обновления

Жизненный цикл

Появились вопросы?

Ознакомьтесь с FAQ