YY 0793.1-2010 Technical requirements of water treatment equipments for haemodialysis applications and related therapies.Part 1:For multi-beds haemodialysis (English Version)
This standard specifies the terms and definitions, product classification, requirements, test methods, inspection rules, signs, instructions for use, packaging, transportation and storage of multi-bed hemodialysis and related therapeutic water treatment equipment. This standard is applicable to water treatment equipment for preparing multi-bed hemodialysis and related treatment water. It is not applicable to water treatment equipment for preparing single-bed hemodialysis and related treatment water. The water involved includes: water for powder preparation concentrate, water for dialysate preparation, and water for dialyzer reuse. The scope of water treatment equipment specified in this standard covers all devices, pipelines and accessories from the connection point where municipal (including self-service) drinking water sources enter the equipment to the point of use of the equipment's produced water, including: electrical systems, water purification systems, Storage and conveying systems and disinfection systems, etc. Excludes: concentrate supply system, dialysate regeneration system, dialysis concentrate, hemodiafiltration system, hemofiltration system, dialyzer reuse system and peritoneal dialysis system, etc.
YY 0793.1-2010 Referenced Document
GB 4793.1 Safety requirements for electrical equipment for measurement,control,and laboratory use.Part 1:General requirements
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 14710 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 18204.27 Method of examination of ozone in air of public places
GB/T 191 Packaging.Pictorial marking for handling of goods
GB/T 19108 Determination of peracetic acid content
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/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*, 2023-09-05 Update
YY 0793.1-2010 history
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
2010YY 0793.1-2010 Technical requirements of water treatment equipments for haemodialysis applications and related therapies.Part 1:For multi-beds haemodialysis
YY 0793.1-2010 Technical requirements of water treatment equipments for haemodialysis applications and related therapies.Part 1:For multi-beds 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.