YY 0793.2-2011 Replaced Industry standards-Medicine

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

Publish Date: 2011-12-31 Implement Date: 2013-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0793.2-2011

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: 2011-12-31

Implement Date: 2013-06-01

Pages: 13 pages

Scope

This part of YY 0793 specifies the terms and definitions, requirements, test methods, inspection rules, marking, user manuals, packaging, transportation, and storage for water treatment equipment used in single-bed hemodialysis and related treatments (hereinafter referred to as the equipment).
This part applies to water treatment equipment for preparing water used in single-bed hemodialysis and related treatments, but not to water treatment equipment for preparing water used in multi-bed hemodialysis and related treatments. The water covered by this part includes:
a) water used for preparing dialysis concentrate;
b) water used for preparing dialysis solution;
c) water used for reuse of dialyzers.
The equipment specified in this part includes all devices, pipelines, and fittings between the connection point where municipal drinking water enters the equipment and the point where the treated water is used in the equipment. It does not include:
a) the concentrate supply system;
b) the dialysis solution regeneration system;
c) dialysis concentrate;
d) hemodialysis filtration systems;
e) blood filtration systems;
f) dialyzer reuse systems and peritoneal dialysis systems, etc.

Development Information

Word Count: 22 Thousand words Pages: 13 pages

Superseded by the following standards

YY/T 0793.1-2022 Preparation and quality management of fluids for haemodialysis and related therapies—Part 1:Water treatment equipment for haemodialysis applications and related therapies

Referenced Standards

GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods 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 17219-1998 Standard for safety evaluation of equipment and protective materials in drinking water system GB 19104-2003 Peracetic acid solution GB/T 19104-2008 Peracetic acid solution GB/T 19104-2021 Peracetic acid solution 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 YY 0709-2009 Medical electrical equipment—Part 1-8:General requirements for safety—Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems YY 0793.1-2010 Technical requirements of water treatment equipments for haemodialysis applications and related therapies—Part 1:For multi-beds haemodialysis YY/T 0793.1-2022 Preparation and quality management of fluids for haemodialysis and related therapies—Part 1:Water treatment equipment for haemodialysis applications 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

Related Standards

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Publish Date: 1990-01-08

GB 12279-1990 Replaced

GB 12279-1990 Cardiac valve prostheses general technical specification

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GB 12417-1990 Replaced

GB 12417-1990 The general technological conditions of surgical metal implant

Publish Date: 1990-07-17

GB/T 13461-1992 Replaced

GB/T 13461-1992 Synthetic resin blow knee prostheses

Publish Date: 1992-06-01

GB/T 14191-1993 Replaced

GB/T 14191-1993 Terminology for prosthetics and orthotics

Publish Date: 1993-02-25

GB 14722-1993 Replaced

GB 14722-1993 Endoskeletal above knee prosthesis

Publish Date: 1993-12-04