ISO 7199:2016 心血管植入体和人工器官 血液气体换热器（氧合器）

标准编号：ISO 7199:2016

中文名称：心血管植入体和人工器官 血液气体换热器（氧合器）

英文名称：Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)

发布日期：2016-11

标准范围

This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.This document also applies to external equipment unique to the use of the oxygenator.This document does not apply to— implanted oxygenators,— liquid oxygenators,— extracorporeal circuits (blood tubing),— separate heat exchangers,— separate ancillary devices, and— separate arterial line filter.

标准预览图