GB/T 4506-1984
Abolished
YY/T 1291-2016
Active
Industry standards-Medicine
YY/T 1291-2016 Single use subcutaneous infusion sets for use with insulin pump
YY/T 1291-2016 Single use subcutaneous infusion sets for use with insulin pump
Basic Information
Standard Code:
YY/T 1291-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Blood transfusion, infusion, and injection equipment
Publish Date:
2016-03-23
Implement Date:
2017-01-01
Pages:
19 pages
Scope
This standard specifies the requirements for subcutaneous infusion sets (referred to as "subcutaneous infusion sets") used with insulin pumps, which consist of interfaces, tubing, and puncture components. This product is a single-use sterile product.
This standard does not include the requirements for devices used to fill insulin in insulin pumps (such as drug reservoirs and pre-filled sealed cartridges).
This standard does not address the accuracy requirements for flow control when the subcutaneous infusion sets are used with insulin pumps.
Development Information
Referenced Standards
GB 8368-2005 Infusion sets for single use, gravity feed
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
YY/T 0148-2006 Medical adhesive bandages—General requirements
YY 0285.1-2004 Sterile,single-use intravascular catheters—Part 1:General requirements
YY 0285.5-2004 Sterile,single-use intravascular catheters—Part 5:Over-needle peripheral catheters
ISO 11607-1:2006
GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment—Part 2:Lock fittings
GB 9706.27-2005 Medical electrical equipment—Part 2-24:Particular requirements for the safety of infusion pumps and controllers
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB 18457-2001 Stainless steel needle tubing for manufacture of medical devices
GB/T 18457-2015 Stainless steel needle tubing for the manufacture of medical devices
GB/T 18457-2024 Stainless steel needle tubing for the manufacture of medical devices—Requirements and test methods
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/T 0615.1-2007 Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices
Related Standards
GB/T 11751-1989
Abolished
GB/T 11751-1989 Flexible polymeric tubes for medical use—Dimension
GB/T 12256-1990
Abolished
GB/T 12256-1990 Test method for stiffness of hypodermic needle tubing
GB/T 13074-1991
Replaced
GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration
GB 14232-1993
Abolished
GB 14232-1993 Bags for human blood and blood components
GB/T 14233.2-1993
Replaced