YY/T 1274-2016
Active
Industry standards-Medicine
YY/T 1274-2016 Pressure control peritoneal dialysis equipment
YY/T 1274-2016 Pressure control peritoneal dialysis equipment
Basic Information
Standard Code:
YY/T 1274-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2016-03-23
Implement Date:
2018-01-01
Pages:
8 pages
Scope
This standard specifies the terms and definitions, classification, requirements, test methods, marking, user manuals, and packaging, transportation, and storage of pressure-controlled peritoneal dialysis equipment.
This standard applies to pressure-controlled peritoneal dialysis equipment (hereinafter referred to as the equipment).
This standard does not apply to:
——Disposable consumables used during peritoneal dialysis (such as dialysis solution and dialysis solution pipelines);
——Equipment intended only for continuous non-bed-based peritoneal dialysis;
——Equipment intended for continuous flow-based peritoneal dialysis;
——Gravity-controlled peritoneal dialysis equipment.
Development Information
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 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
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
GB/T 13074-2024 Blood purification terminology
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
Related Standards
GB 12264-1990
Replaced
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