YY/T 0497-2025 Pending Industry standards-Medicine

YY/T 0497-2025 Sterile insulin syringe for single use

YY/T 0497-2025 Sterile insulin syringe for single use

Publish Date: 2025-09-15 Implement Date: 2026-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
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Basic Information

Standard Code: YY/T 0497-2025
Standard Type: Industry standards
Standard Status: Pending
is_force_gb: no
CCS Name: Generally, it refers to microsurgical instruments
ICS Name: Blood transfusion, infusion, and injection equipment
Publish Date: 2025-09-15
Implement Date: 2026-10-01
Pages: 32 pages

Scope

This document specifies the requirements for single-use sterile insulin syringes (hereinafter referred to as syringes) and describes the corresponding test methods. The syringes are for single use only and are used to draw insulin and immediately inject it into humans.
This document applies to syringes for injecting insulin at 40 units per milliliter (U-40) and 100 units per milliliter (U-100).
This document does not apply to syringes for long-term storage of insulin.

Development Information

Word Count: 44 Thousand words Pages: 32 pages

Replace the following standards

Referenced Standards

GB/T 6682-1992 Water for analytical laboratory use—Specification and test methods GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods 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/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods GB 15810-2019 Sterile syringes for single use GB 15811-2001 Sterile hypodermic needles for single use GB 15811-2016 Sterile hypodermic needles for single use GB 15811-2025 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 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 GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices 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 ISO 80369-7

Adopt standards

ISO 8537:2016

Related Standards

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