YY 0054-2010 Active Industry standards-Medicine

YY 0054-2010 Haemodialysis equipment

YY 0054-2010 Haemodialysis equipment

Publish Date: 2010-12-27 Implement Date: 2012-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0054-2010

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: 2010-12-27

Implement Date: 2012-06-01

Pages: 17 pages

Scope

This standard specifies the terms and definitions, classification and basic parameters, requirements, test methods, inspection rules, marking, user manuals, and packaging, transportation, and storage requirements for hemodialysis equipment.
This standard applies to hemodialysis equipment with automatic fluid dispensing (hereinafter referred to as the equipment).
This standard does not apply to:
——Water treatment equipment for hemodialysis;
——Peritoneal dialysis equipment;
——Hemoperfusion, plasma exchange, and plasma adsorption equipment;
——Continuous blood purification equipment.

Development Information

Word Count: 36 Thousand words Pages: 17 pages

Replace the following standards

YY 0054-2003 Haemodialysis、haemodiafiltration and haemofiltration equipment

Superseded by the following standards

YY 0054-2023 Haemodialysis equipment

Referenced Standards

中华人民共和国药典(2005版) 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 9706.2-2003 Medical electrical equipment—Part 2-16:Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration 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 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/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 0598-2006 Concentrates for haemodialysis and related therapies YY 0598-2015 Concentrates for haemodialysis and related therapies GB/T 13074-2024 Blood purification terminology GB/T 191-2025 Graphical symbols marking for handling and storage of packages

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