GB/T 4506-1984
Abolished
YY 0485-2020
Active
Industry standards-Medicine
YY 0485-2020 Single-use cardioplegia delivery system
YY 0485-2020 Single-use cardioplegia delivery system
Basic Information
Standard Code:
YY 0485-2020
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name:
Blood transfusion, infusion, and injection equipment
Publish Date:
2020-06-30
Implement Date:
2021-12-01
Publisher:
国家药品监督管理局
Technical Committee:
全国医用体外循环设备标准化技术委员会(SAC/TC 158)
Pages:
8 pages
Scope
本标准规定了一次性使用心脏停跳液灌注器的结构与分类、要求、试验方法。
本标准适用于一次性使用心脏停跳液灌注器(以下简称灌注器)。灌注器供体外循环心脏直视手术作心脏停跳液灌注用。
Development Information
Drafting Units:
广东省医疗器械质量监督检验所、山东威高新生医疗器械有限公司、宁波菲拉尔医疗用品有限公司
Drafting Persons:
何晓帆、许朝生、徐苏华、梁泽鑫、熊伟、王毅、孔建明
Replace the following standards
Referenced Standards
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB 19335-2003 Blood flow products for single use—General specification
YY/T 0149-2006 Medical instruments of stainless steel—Test methods of corrosion resistance
中华人民共和国药典
GB/T 1962.1-2001 Conical fittings with a6%(Luer)taper for syringes, needles and certain other medical equipment Part 1:General requirement
GB/T 1962.1-2015 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment—Part 1:General requirement
GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment—Part 2:Lock fittings
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB 18278.1-2015 Sterilization of health care products—Moist heat—Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
YY/T 0681.1-2009 Test methods for sterile medical device package—Part 1:Test guide for accelerated aging
YY/T 0681.1-2018 Test methods for sterile medical device package—Part 1:Test guide for accelerated aging
GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices
Related Standards
GB/T 11751-1989
Abolished
GB/T 11751-1989 Flexible polymeric tubes for medical use—Dimension
GB/T 12256-1990
Abolished
GB/T 12256-1990 Test method for stiffness of hypodermic needle tubing
GB/T 13074-1991
Replaced
GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration
GB 14232-1993
Abolished
GB 14232-1993 Bags for human blood and blood components
GB/T 14233.2-1993
Replaced