недоступно на русском языке

Тезис Предпросмотр

ISO 16142:2016, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended. This part of ISO 16142 identifies and describes the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic).

ISO 16142:2016also identifies and describes the additional essential principles of safety and performance which need to be considered during the design and manufacturing process, which are relevant to medical devices other than IVD medical devices. Future ISO 16142‑2 is intended to identify and describe the essential principles of safety and performance, which need to be considered during the design and manufacturing process of IVD medical devices.

NOTE During the design process, the manufacturer selects which of the listed design and manufacturing principles apply to the particular medical device and documents the reasons for excluding others.

ISO 16142:2016 is intended for use as guidance by medical device manufacturers, standards development organizations, authorities having jurisdiction, and conformity assessment bodies.


Общая информация

  • Текущий статус :  Published
    Дата публикации : 2016-03
  • Версия : 1
    Число страниц : 47
  • :
    ISO/TC 210
    Quality management and corresponding general aspects for medical devices
  • 11.040.01
    Medical equipment in general

Приобрести данный стандарт

Формат Язык
PDF + ePub
Бумажный
  • CHF158

Жизненны цикл

Стандарт, который пересматривается каждые 5 лет



Изменения / Исправления

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)

Будьте в курсе актуальных новостей ИСО

Подписывайтесь на наши новости, обзоры, а также на информацию о продуктах