YY 0793.2-2011
Technical requirements of water treatment equipments for haemodialysis applications and related therapies.Part 2:For single-bed haemodialysis (English Version)

Standard No.
YY 0793.2-2011
Language
Chinese, Available in English version
Release Date
2011
Published By
Professional Standard - Medicine
Status
 2026-12
Replace By
YY/T 0793.1-2022
YY 0793.2-2023
Latest
YY 0793.2-2023
Scope
This part of YY 0793 specifies the terms and definitions, requirements, test methods, inspection rules, markings, instructions for use, packaging, transportation and storage of single-bed hemodialysis and related therapeutic water treatment equipment (hereinafter referred to as equipment). This section applies to water treatment equipment that prepares single-bed hemodialysis and related treatment water, but does not apply to water treatment equipment that prepares multi-bed hemodialysis and related treatment water. Water within the scope of application of this section refers to: a) water for preparing dialysis concentrate; b) water for preparing dialysate; c) water for dialyzer reuse. The scope of equipment specified in this section includes all devices, pipelines and accessories from the connection point where the municipal drinking water source enters the equipment to the point of use of the equipment's treated water. Excludes: a) Concentrate supply system; b) Dialysate regeneration system; c) Dialysate concentrate; d) Hemodiafiltration system; e) Hemofiltration system; f) Dialyzer reuse system and peritoneal dialysis system etc.

YY 0793.2-2011 Referenced Document

  • GB 19104 Peracetic acid solution
  • GB 5749 Hygienic Standards for Drinking Water*2022-03-15 Update
  • GB 9706.1 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance*2020-04-09 Update
  • GB/T 13074 Terms of blood purification
  • GB/T 14710-2009 Enviromental requirement and test methods for medical electrical equipment
  • GB/T 17219 Standard for safety evaluation of equipment and protective materials in drinking water system
  • GB/T 191 Packaging.Pictorial marking for handling of goods
  • GB/T 5750.10 Standard Examination Methods for Drinking Water Part 10: Indicators of Disinfection Byproducts*2023-03-17 Update
  • GB/T 5750.11 Standard Examination Methods for Drinking Water Part 11: Disinfectant Index*2023-03-17 Update
  • GB/T 5750.2 Standard Examination Methods for Drinking Water Part 2: Collection and Preservation of Water Samples*2023-03-17 Update
  • GB/T 9969 General principles for preparation of instructions for use of industrial products
  • YY 0572 Water for haemodialysis and related therapies*2015-03-02 Update
  • YY 0793.1 Technical requirements of water treatment equipments for haemodialysis applications and related therapies.Part 1:For multi-beds haemodialysis
  • YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*2023-09-05 Update

YY 0793.2-2011 history

  • 2023 YY 0793.2-2023 Preparation and quality management of fluids for hemodialysis and related treatments Part 2: Water for hemodialysis and related treatments
  • 2022 YY/T 0793.1-2022 Preparation and quality management of fluids for hemodialysis and related treatments Part 1: Water treatment equipment for hemodialysis and related treatments
  • 2011 YY 0793.2-2011 Technical requirements of water treatment equipments for haemodialysis applications and related therapies.Part 2:For single-bed haemodialysis

YY 0793.2-2011 Technical requirements of water treatment equipments for haemodialysis applications and related therapies.Part 2:For single-bed haemodialysis was changed to YY/T 0793.1-2022 Preparation and quality management of fluids for hemodialysis and related treatments Part 1: Water treatment equipment for hemodialysis and related treatments.

Technical requirements of water treatment equipments for haemodialysis applications and related therapies.Part 2:For single-bed haemodialysis



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