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

ISO 7199:2016规定了用于向人体血液供氧和去除血液中二氧化碳的无菌一次性体外血气交换器（氧合器）的要求。ISO 7199:2016也适用于作为氧合器组成部分的热交换器和动脉过滤器。ISO 7199:2016也适用于氧合器专用的外部设备。ISO 7199:2016不适用于-植入氧合器，-液体氧合器，-体外循环（血管），-单独的热交换器，-单独的辅助设备，以及-单独的动脉管路过滤器。

ISO 7199:2016 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.ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.ISO 7199:2016 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