T/CSBME 004-2018 Active Group standards

T/CSBME 004-2018 Configuration list of equipment and materials for extracorporeal circulation(heart and lung)

T/CSBME 004-2018 Configuration list of equipment and materials for extracorporeal circulation(heart and lung)

Publish Date: 2018-12-20 Implement Date: 2019-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CSBME 004-2018

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2018-12-20

Implement Date: 2019-03-01

Pages: 12 pages

Scope

This standard specifies the classification, composition, functions, and requirements of the basic equipment and materials that medical institutions conducting cardiopulmonary extracorporeal circulation (ECMO) technology should possess. ECMO technology encompasses extracorporeal life or organ support techniques that maintain blood circulation outside the body. The scope of "cardiopulmonary extracorporeal circulation" in this standard is limited to those ECMO techniques that support heart and lung function. This standard applies to medical institutions that conduct two types of cardiopulmonary ECMO technologies: cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). It specifies the minimum requirements for basic equipment, supporting instruments, and corresponding consumables necessary to ensure the safe implementation of these medical technologies.

Development Information

Word Count: 18 Thousand words Pages: 12 pages

Referenced Standards

GB 9706.8-2009 Medical electrical equipment—Part 2-4:Particular requirements for the safety of cardiac defibrillators GB 12260-2017 Cardiopulmonary bypass systems—Roller blood pump GB 12263-2017 Cardiopulmonary bypass systems—Water heating/cooling system GB/T 19634-2005 In vitro diagnostic test systems—General technical requirements for blood-glucose monitoring systems for self-testing YY 0053-2016 Hemodialysis and relevant therapies—Haemodialysers,haemodiafilters,haemofilters and haemoconcentrators YY 0485-2011 Single-used cardioplegia delivery system YY 0505-2012 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests YY 0580-2011 Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial blood line filters YY/T 0589-2016 Electrolyte analyzer YY/T 0593-2015 Ultrasound transcranial Doppler system YY 0604-2016 Cardiopulmonary bypass systems—Blood-gas exchangers(oxygenators) YY/T 0659-2017 Blood coagulation analyzer YY 0948-2015 Cardiopulmonary bypass systems—Arteriovenous cannula for single use YY 1048-2016 Cardiopulmonary bypass systems—Extracorporeal blood circuit YY/T 1145-2014 Terms of cardiopulmonary bypass systems YY/T 1270-2015 Cardiopulmonary bypass systems—Blood lines connector YY/T 1271-2016 Cardiopulmonary bypass systems—Suction catheter for single use YY 1412-2016 Cardiopulmonary bypass systems—Centrifugal pump YY/T 1566.1-2017 Autologous blood processing devices for single use—Part 1:Blood cell recoery sets,centrifuge bowl type

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