GB/T 4506-1984
Abolished
YY/T 0497-2018
Active
Industry standards-Medicine
YY/T 0497-2018 Sterile insulin syringe for single use
YY/T 0497-2018 Sterile insulin syringe for single use
Basic Information
Standard Code:
YY/T 0497-2018
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:
2018-04-11
Implement Date:
2019-05-01
Pages:
25 pages
Scope
This standard specifies the requirements and testing methods for disposable sterile insulin syringes (hereinafter referred to as syringes), which are intended for single use only and are used for injecting insulin into the human body immediately after aspirating it. This standard applies to syringes for injecting insulin at a dosage of 40 units per milliliter (U40) and 100 units per milliliter (U100). This standard does not apply to syringes for long-term storage of insulin.
Development Information
Replace the following standards
Referenced Standards
GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB 15810-2001 Sterile hypodermic syringes for single use
GB 18278.1-2015 Sterilization of health care products—Moist heat—Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
ISO 7000:2014
ISO 81714-1:2010
GB/T 1962.1-2001 Conical fittings with a6%(Luer)taper for syringes, needles and certain other medical equipment Part 1:General requirement
GB/T 1962.1-2015 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment—Part 1:General requirement
GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
GB 15811-2001 Sterile hypodermic needles for single use
GB 15811-2016 Sterile hypodermic needles for single use
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
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems
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 15811-2025 Sterile hypodermic needles for single use
GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
Adopt standards
ISO 8537:2007
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