Тезис

This International Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term implant, hereinafter referred to as implants.

It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.

Some tests required to demonstrate compliance with this International Standard are contained in or referenced in level 3 standards.


Общая информация 

  • Текущий статус
     : Отозвано
    Дата публикации
     : 2002-11
  • Версия
     : 1
  • Технический комитет
     : ISO/TC 150/SC 4 Bone and joint replacements
  • ICS
     :
    11.040.40 Implants for surgery, prosthetics and orthotics

Жизненный цикл

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. МКС
  5. 11
  6. 11.040
  7. 11.040.40
  8. ISO 21534:2002