Standard Number: YY/T 0730-2023(YY/T0730-2023)
Chinese:心血管外科植入物和人工器官 心肺旁路和体外膜肺氧合（ECMO）使用的一次性使用管道套包的要求
English:Cardiovascular implants and artificial organs Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation(ECMO)
Effective Date:2024-01-15
ICS:11.040.40
Standard Applicability:This document establishes requirements for single-use tubing sleeves for use in cardiopulmonary bypass (CPB) and extracorporeal membrane pulmonary oxygenation (ECMO). This document applies to all medical tubing intended for use in cardiopulmonary bypass (CPB) and/or extracorporeal membrane pulmonary oxygenation (ECMO), with the exception of tubing intended to be used in conjunction with blood pumps during CPB procedures (short-term, i.e., less than 6 h) or ECMO (long-term, i.e., more than 24 h), for which specific requirements and test methods apply. The provisions of this document regarding sterility and non-pyrogenicity apply to tubing kits labeled “sterile”. This document applies only to tubing for multifunctional systems that may have complete components such as blood gas exchangers (oxygenators), blood reservoirs, blood microthrombus filters, defoamers, blood pumps, etc.
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