标准号：ISO 15676-2005
实施状态：作废
中文名称：心血管外科植入物和人造器官.心肺分流术和体外膜式氧合(ECMO)用一次性导管包装的要求
英文名称：Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
发布日期：2005-07
被替代标准：ISO 15676-2016
代替标准：ISO/FDIS 15676-2005
采用标准：DS/ISO 15676-2015,IDT;NEN-ISO 15676-2005,IDT
起草单位：ISO/TC 150
标准简介：This International Standard specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This International Standard is applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short-term, i.e. < 6 h duration) CPB surgery, or (long-term, i.e. > 24 h) ECMO procedures. The sterility and non-pyrogenicity provisions of this International Standard are applicable to tubing packs labelled as "sterile".
This International Standard is applicable only to the tubing aspects for multifunctional systems that may have integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters, defoamers, blood pumps, etc.
文件格式：PDF
文件大小：157.19KB
文件页数：14
（以上信息更新时间为：2019-11-22）
ISO 15676-2005 心血管外科植入物和人造器官.心肺分流术和体外膜式氧合(ECMO)用一次性导管包装的要求.pdf
(157.19 KB)
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