YY 0793.2-2011 Technical requirements of water treatment equipments for haemodialysis applications and related therapies.Part 2:For single-bed haemodialysis (English Version)
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.
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
2023YY 0793.2-2023 Preparation and quality management of fluids for hemodialysis and related treatments Part 2: Water for hemodialysis and related treatments
2022YY/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
2011YY 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.