GB 8662-1988
Replaced
YY 0054-2003
Replaced
Industry standards-Medicine
YY 0054-2003 Haemodialysis、haemodiafiltration and haemofiltration equipment
YY 0054-2003 Haemodialysis、haemodiafiltration and haemofiltration equipment
Basic Information
Standard Code:
YY 0054-2003
Standard Type:
Industry standards
Standard Status:
Replaced
is_force_gb:
no
CCS Name:
Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name:
Surgical instruments and materials
Publish Date:
2003-06-20
Implement Date:
2004-01-01
Pages:
11 pages
Scope
This standard specifies the terms and definitions, classification and marking, requirements, test methods, inspection rules, labels, user manuals, and packaging, transportation, and storage of hemodialysis, hemodialysis filtration, and blood filtration equipment. This standard applies to hemodialysis, hemodialysis filtration, and blood filtration equipment (hereinafter referred to as "equipment"). It does not apply to equipment used for continuous renal replacement therapy (CRRT).
Development Information
Replace the following standards
YY 0054-1991
Superseded by the following standards
Referenced Standards
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB 9706.2-2003 Medical electrical equipment—Part 2-16:Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
GB 9969.1-1998 General principles for preparation of instructions for use of industrial products
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 191-2025 Graphical symbols marking for handling and storage of packages
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 0465-2003
Replaced