YY/T 1273-2016
Active
Industry standards-Medicine
YY/T 1273-2016 Roller pump for auxiliary blood purification
YY/T 1273-2016 Roller pump for auxiliary blood purification
Basic Information
Standard Code:
YY/T 1273-2016
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:
7 pages
Scope
This standard specifies the terms and definitions, requirements, test methods, marking, user manuals, packaging, transportation, and storage of roller pumps used in blood purification (hereinafter referred to as roller pumps).
This standard applies to roller pumps used in blood purification as defined in Clause 3.1. These roller pumps cannot be used independently for blood purification treatment.
This standard does not apply to:
—— Blood perfusion equipment;
—— Blood cell separation equipment;
—— Continuous blood purification equipment;
—— Immunoadsorption equipment;
—— Hemodialysis devices;
—— Hemodialysis filtration devices;
—— Centrifugal pumps;
—— Artificial heart-lung machines with roller pumps.
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/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