YY 1493-2016 Active Industry standards-Medicine

YY 1493-2016 Gravity control peritoneal dialysis equipment

YY 1493-2016 Gravity control peritoneal dialysis equipment

Publish Date: 2016-07-29 Implement Date: 2018-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 1493-2016
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name: Surgical instruments and materials
Publish Date: 2016-07-29
Implement Date: 2018-06-01
Pages: 9 pages

Scope

This standard specifies the terms, definitions, classification, requirements, test methods, marking, user's manual, packaging, transportation, and storage requirements for gravity-controlled peritoneal dialysis equipment. This standard applies to gravity-controlled peritoneal dialysis equipment. This standard does not apply to disposable consumables used in the peritoneal dialysis process (such as dialysis solution and dialysis solution pipelines) and pressure-controlled peritoneal dialysis equipment.

Development Information

Pages: 9 pages

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 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 9706.39-2008 Medical electrical equipment—Part 2-39:Particular requirements for the safety of peritoneal dialysis equipment 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 13074-2024 Blood purification terminology GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment 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 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 GB/T 191-2025 Graphical symbols marking for handling and storage of packages

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