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

Publish Date: 2016-03-23 Implement Date: 2017-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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

Word Count: 32 Thousand words Pages: 19 pages

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

Contact Us