ISO 15675:2016
Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters
Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 9
- Дата публикации:
- 15 августа 2016 г.
- Издание:
- ISO IS 15675 edition 3 version 1
- ICS:
- 11.040.40
ISO 15675:2016 specifies requirements for sterile, single-use, arterial blood line filters intended to filter and remove emboli, debris, blood clots and other potentially hazardous solid and gaseous material from the blood of humans during cardiopulmonary bypass surgery.
Abstract
Overview
ISO 15675:2016 defines safety, performance and testing requirements for used in cardiopulmonary bypass (CPB) systems. The standard covers design and manufacturing expectations for filters that remove emboli, debris, blood clots and gaseous material from arterial blood during CPB. It sets biological, physical and performance criteria and describes the tests and documentation manufacturers must provide to demonstrate compliance.
Похожие стандарты
Стандарты, упомянутые в описании