GB 8662-1988
Replaced
YY 1493-2016
Active
Industry standards-Medicine
YY 1493-2016 Gravity control peritoneal dialysis equipment
YY 1493-2016 Gravity control peritoneal dialysis equipment
Basic Information
Standard Code:
YY 1493-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name:
Surgical instruments and materials
Publish Date:
2016-07-29
Implement Date:
2018-06-01
Pages:
9 pages
Scope
This standard specifies the terms, definitions, classification, requirements, test methods, marking, user's manual, packaging, transportation, and storage requirements for gravity-controlled peritoneal dialysis equipment. This standard applies to gravity-controlled peritoneal dialysis equipment. This standard does not apply to disposable consumables used in the peritoneal dialysis process (such as dialysis solution and dialysis solution pipelines) and pressure-controlled peritoneal dialysis equipment.
Development Information
Referenced Standards
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
GB 9706.39-2008 Medical electrical equipment—Part 2-39:Particular requirements for the safety of peritoneal dialysis equipment
GB/T 9969-2008 General principles for preparation of instructions for use of industrial products
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 14710-2009 Environmental requirement and test methods for medical electrical equipment
YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
YY 0709-2009 Medical electrical equipment—Part 1-8:General requirements for safety—Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
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 0054-2003
Replaced