GB 12264-1990
Replaced
YY 0793.1-2010
Replaced
Industry standards-Medicine
YY 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
Basic Information
Standard Code:
YY 0793.1-2010
Standard Type:
Industry standards
Standard Status:
Replaced
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:
14 pages
Scope
This standard specifies the terms and definitions, product classification, requirements, test methods, inspection rules, marking, user's manual, packaging, transportation, and storage for water treatment equipment used in multi-bed hemodialysis and related treatments (hereinafter referred to as water treatment equipment).
This standard applies to water treatment equipment used in preparing water for multi-bed hemodialysis and related treatments, but not to water treatment equipment used in preparing water for single-bed hemodialysis and related treatments. The water involved includes: water for powder preparation of concentrated solution, water for dialysis solution preparation, and water for dialyzer reuse.
The scope of water treatment equipment specified in this standard includes all devices, pipelines, and accessories between the connection point where municipal (including self-extracted) drinking water enters the equipment and the point where the produced water is used, including: electrical systems, water purification systems, storage and transportation systems, and disinfection systems. It does not include: concentrated solution supply systems, dialysis solution regeneration systems, dialysis concentrates, hemodialysis filtration systems, blood filtration systems, dialyzer reuse systems, and peritoneal dialysis systems.
Development Information
Superseded by the following standards
Referenced Standards
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB 4793.1-1995 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1:General requirements
GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1:General requirements
GB 5749-1985 Sanitary standard for drinking water
GB 5749-2006 Standards for drinking water quality
GB 5749-2022 Standards for drinking water quality
GB/T 5750.2-2006 Standard examination methods for drinking water—Collection and preservation of water samples
GB/T 5750.2-2023 Standard examination methods for drinking water—Part 2:Collection and preservation of water samples
GB/T 5750.10-2006 Standard examination methods for drinking water—Disinfection by-products parameters
GB/T 5750.10-2023 Standard examination methods for drinking water—Part 10:Disinfection by-products indices
GB/T 5750.11-2006 Standard examination methods for drinking water—Disinfectants parameters
GB/T 5750.11-2023 Standard examination methods for drinking water—Part 11:Disinfectants indices
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/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
GB/T 17219-1998 Standard for safety evaluation of equipment and protective materials in drinking water system
GB/T 18204.27-2000 Method of examination of ozone in air of public places
GB 19108-2003 Peracetic acid solution-Determination of peracetic acid content
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 0572-2005 Water for haemodialysis and related therapies
YY 0572-2015 Water for haemodialysis and related therapies
GB/T 13074-2024 Blood purification terminology
GB/T 17219-2025 Hygienic safety evaluation of distribution equipment,protective materials and treatment materials in drinking water system
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
Adopt standards
ISO 26722:2009
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