недоступно на русском языке

Тезис

 Preview

This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series.

This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade.

This document is not applicable to:

a) the evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available;

NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993.

b) leachable components which are not degradation products;

c) medical devices or components that do not contact the patient's body directly or indirectly.


Общая информация 

  • Текущий статус
     : Опубликовано
    Дата публикации
     : 2019-11
  • Версия
     : 3
  • Технический комитет
     : ISO/TC 194 Biological and clinical evaluation of medical devices
  • ICS
     :
    11.100.20 Biological evaluation of medical devices

Приобрести данный стандарт

Формат Язык
PDF
Бумажный
  • CHF61

Жизненный цикл

Цели в области устойчивого развития

Данный стандарт разработан для достижения следующих Цель устойчивого развития

3
Хорошее здоровье и благополучие

Появились вопросы?

Ознакомьтесь с FAQ

Работа с клиентами
+41 22 749 08 88

Часы работы:
Понедельник – пятница: 09:00-12:00, 14:00-17:00 (UTC+1)

  2. Интернет-магазин
  3. Каталог стандартов
  4. ТК
  5. ISO/TC 194
  6. ISO 10993-9:2019