GB 12263-2017

Active

Cardiopulmonary bypass systems—Water heating/cooling system

心肺转流系统 热交换水箱

Standard Type
GB
ICS
11.040.40
CCS
C45
Status
Active
Issue Date
2017-12-29
Implementation
2019-07-01
Centralized Committee
国家药监局
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

GB 12263-2017 specifies technical requirements, safety performance, and testing methods for water heating/cooling systems used in cardiopulmonary bypass (heart-lung machines). It applies to medical devices that regulate blood temperature during open-heart surgery or extracorporeal circulation procedures. The standard ensures precise thermal control and patient safety in hospital operating rooms and intensive care units.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.