GB 12264-1990
Replaced
YY 0054-2023
Active
Industry standards-Medicine
YY 0054-2023 Haemodialysis equipment
YY 0054-2023 Haemodialysis equipment
Price:
$ 54
Basic Information
Standard Code:
YY 0054-2023
Standard Type:
Industry 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:
2023-01-13
Implement Date:
2026-01-15
Pages:
22 pages
Scope
This document specifies the classification and requirements of hemodialysis equipment and describes the test methods.
This document applies to automatic dosing hemodialysis equipment (hereinafter referred to as the equipment).
This document does not apply to:
——Water treatment equipment for hemodialysis;
——Peritoneal dialysis equipment;
——Hemoperfusion, plasma exchange, and plasma adsorption equipment;
——Continuous blood purification equipment;
——Central supply systems;
——Hemodialysis equipment with recyclable dialysis solution.
Development Information
Replace the following standards
Referenced Standards
YY/T 1272-2016 Dialysis fluid filter
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 9706.216-2021 Medical electrical equipment—Part 2-16:Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
YY 0598-2006 Concentrates for haemodialysis and related therapies
YY 0598-2015 Concentrates for haemodialysis and related therapies
YY 9706.108-2021 Medical electrical equipment—Part 1-8:General requirements for basic safety and essential performance-Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced