ISO 14708-5:2020

Тезис

This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements.

NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.

The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses and are not intended to be used for the routine testing of manufactured products.

Included in the scope of this document are:

— ventricular assist devices (VAD), left or right heart support;

— total artificial hearts (TAH);

— biventricular assist devices (biVAD);

— percutaneous assist devices;

— paediatric assist devices.

Общая информация

Текущий статус
: Published

Дата публикации
: 2020-05
Версия
: 2
Технический комитет
: ISO/TC 150/SC 6 Active implants
ICS
:
11.040.40 Implants for surgery, prosthetics and orthotics

Данный стандарт разработан для достижения следующих Цель устойчивого развития:

Хорошее здоровье и благополучие

Приобрести данный стандарт

	Формат	Язык
std 1 187	PDF + ePub
std 2 187	Бумажный

CHF187

Жизненный цикл

Появились вопросы?

Ознакомьтесь с FAQ

Работа с клиентами

+41 22 749 08 88

customerservice@iso.org

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.

недоступно на русском языке