GB 8662-1988
Replaced
YY 0267-2025
Pending
Industry standards-Medicine
YY 0267-2025 Extracorporeal systems for blood purification—Extracorporeal blood and fluidcircuits for haemodialysers,haemodiafilters,haemofilters and haemoconcentrators
YY 0267-2025 Extracorporeal systems for blood purification—Extracorporeal blood and fluidcircuits for haemodialysers,haemodiafilters,haemofilters and haemoconcentrators
Basic Information
Standard Code:
YY 0267-2025
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name:
Surgical instruments and materials
Publish Date:
2025-02-26
Implement Date:
2028-03-01
Pages:
24 pages
Scope
This document specifies the requirements for single-use extracorporeal circulation blood/fluid circuits (hereinafter referred to as extracorporeal circulation blood/fluid circuits) and accessories used in conjunction with blood dialysis, hemodialysis, hemofiltration, and blood concentration, and describes the corresponding test methods.
This document applies to single-use extracorporeal circulation blood/fluid circuits and accessories used in conjunction with blood dialysis, hemodialysis, hemofiltration, and blood concentration.
This document does not apply to:
— Hemodialysis machines, hemodialysis filters, or hemofiltration filters;
— Plasma separators;
— Blood perfusion devices;
— Vascular access devices.
Note 1: The requirements for hemodialysis machines, hemodialysis filters, hemofiltration filters, and blood concentrators are specified in YY 0053.
Note 2: The requirements for plasma separators are specified in YY 0465.
Development Information
Replace the following standards
Referenced Standards
GB/T 6682-1992 Water for analytical laboratory use—Specification and test methods
GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods
GB 9706.216-2021 Medical electrical equipment—Part 2-16:Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration
GB/T 13074-2009 Terms of blood purification
GB/T 13074-2024 Blood purification terminology
GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB 15811-2001 Sterile hypodermic needles for single use
GB 15811-2016 Sterile hypodermic needles for single use
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/T 19335-2022 Blood flow products for single use—General specification
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
YY/T 0916.7-2024 Small-bore connectors for liquids and gases in healthcare applications—Part 7:Connectors for intravascular or hypodermic applications
中华人民共和国药典
GB 15811-2025 Sterile hypodermic needles for single use
Adopt standards
ISO 8637-2:2024
Related Standards
GB 2766-1995
Replaced
GB 2766-1995 Haemostatic forceps with box joint—General specifications
GB/T 10160-1995
Abolished
GB/T 10160-1995 Test methods of locking force and opening force for medical use forceps
GB 9706.4-1999
Replaced
GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment
YY 0464-2003
Replaced
YY 0464-2003 Single use hemoperfutor
YY 0054-2003
Replaced