1

YY 0304-2023

Plasma sprayed hydroxyapatite coated titanium dental implants

revise

YY 0304-2009

This document specifies the technical requirements and test methods for plasma sprayed hydroxyapatite coating titanium based dental implants. This document applies to plasma sprayed hydroxyapatite coatings made of forged titanium or titanium alloy materials as matrix materials - titanium based dental implants.

September 15, 2026

2

YY 0306-2023

General technical requirements for thermal radiation therapy equipment

revise

YY 0306-2018

This document specifies the requirements and test methods for thermal radiation therapy equipment. This document is applicable to thermal radiation therapy equipment. This document does not apply to devices where thermal radiation energy cannot directly reach the patient's body surface, such as those that are obstructed by non hollow structures or non transparent materials during propagation; Equipment defined in YY/T 0165 for treating patients through thermal conduction; Equipment defined in YY 0323 that is expected to cause tissue degeneration and/or coagulation necrosis; Contact type far-infrared therapy equipment as defined in YY/T 0902.

September 15, 2026

3

YY 0451-2023

Non electric drive for disposable portable infusion pumps

revise

YY 0451-2010

This document specifies the basic requirements and corresponding test methods for disposable portable infusion pumps - non electric drive (hereinafter referred to as infusion pumps). This document applies to infusion pumps for sustainable (fixed or adjustable) and/or self controlled fluid delivery for neurological, intravascular, or subcutaneous applications. This document does not apply to electric or electronically controlled infusion pumps covered by GB 9706.224; A device for delivering discrete (pill) solutions covered by the YY/T 1768 series for individual patients; Implantable instruments; Intestinal feeding pump; Transdermal liquid delivery device; The infusion power is not provided by the device itself or obtained by the patient's active intervention (for example, a device powered solely by gravity).

September 15, 2026

4

YY 0717-2023

Dental root canal sealing materials

revise

YY 0717-2009

This document specifies the performance requirements and test methods for dental root canal sealing materials used for permanent sealing of dental root canals. This document applies to root canal sealing materials that can solidify in damp or non humid environments, can be used in combination with or without root canal filling tips, and can be used alone, with forward filling (i.e. root canal filling from the crown of the tooth).

September 15, 2026

5

YY 0852-2023

Disposable sterile surgical membrane

revise

YY 0852-2011

This document specifies the performance requirements for polyurethane surgical films and polyethylene surgical films that are pasted on the surgical site and provide sterile protection for surgical incisions, and describes the corresponding test methods. This document applies to polyurethane surgical membranes and polyethylene surgical membranes.

September 15, 2026

6

YY 0875-2023

Surgical instruments - Linear staplers and components

revise

YY 0875-2013、YY 0876-2013

This document specifies the structural type and materials, requirements, test methods, labels, instructions, and packaging of linear staplers. This document applies to linear staplers and components. This document is not applicable to vascular staplers, curved staplers, and staplers used under laparoscopy.

September 15, 2026

7

YY 1277-2023

Biological safety performance requirements for pressure steam sterilizers

revise

YY 1277-2016

This document specifies the biosafety performance requirements for pressure steam sterilizers (hereinafter referred to as sterilizers) and describes the corresponding test methods. This document applies to the sterilization of materials, instruments, vessels, culture media, and waste materials aimed at biosafety, in order to prevent contamination of personnel, animals, plants, or the environment caused by pathogenic factors transmitted through aerosols or other means. The sterilizers specified in this document are usually used in laboratories or other places with biosafety requirements and a biosafety protection level of level 2 or above. This document does not specify safety requirements related to the scope of usage risks, nor does it specify requirements for confirmation and routine control of wet heat sterilization. This document is not applicable to the sterilization of closed liquids.

September 15, 2026

8

YY/T 0290.5-2023

Ophthalmic optics - Artificial intraocular lenses - Part 5: Biocompatibility

revise

YY/T 0290.5-2008

This document specifies the specific requirements for the biocompatibility evaluation of artificial lenses, including the biocompatibility evaluation requirements of materials under production process conditions, the evaluation of physical and chemical properties related to biocompatibility, and eye implantation test methods. This document is applicable to artificial lenses.

September 15, 2024

9

YY/T 0466.1-2023

Symbols for providing information to manufacturers of medical devices - Part 1: General requirements

revise

YY/T 0466.1-2016

This document specifies the symbols used to express the provision of medical device information. This document applies to the symbols used in various medical devices that are available globally and require compliance with different regulatory requirements. These symbols can be used on the medical device itself, on its packaging, or in accompanying information. The requirements of this document are not intended to be used for symbols specified in other standards.

September 15, 2025

10

YY/T 0675-2023

Ophthalmic instruments - Synoptic machines

revise

YY/T 0675-2008

This document sets out the minimum requirements and test methods for synoptic cameras. Synopsis machines are used to examine, measure, train, and correct the patient's binocular vision, as well as measure horizontal, vertical, and rotational deviations at different gaze positions. This document is applicable to the same camera.

September 15, 2024

11

YY/T 0698.5-2023

Packaging materials for terminally sterilized medical devices - Part 5: Requirements and test methods for sealable combination bags and rolls composed of breathable materials and plastic films

revise

YY/T 0698.5-2009

This document specifies the requirements and test methods for sealable combination bags and rolls composed of breathable materials in accordance with YY/T 0698.2, 0698.3, 0698.6, 0698.7, 0698.9 or 0698.10 and plastic films that comply with clause 4 of this document. These sealable combination bags and rolls can be used as sterile barrier systems and/or packaging systems to ensure the sterility of the final sterilized medical device until use. In addition to the general requirements specified in GB/T 19633.1 and GB/T 19633.2, this document specifies the specific requirements and test methods for the materials covered by this section. This document only applies to packaging materials for disposable final sterilized medical devices.

September 15, 2024

12

YY/T 0767-2023

General technical requirements for color ultrasound imaging equipment

revise

YY/T 0767-2009

This document specifies the requirements for color ultrasound imaging equipment and describes the corresponding test methods. This document is applicable to color ultrasound imaging equipment.

September 15, 2024

13

YY/T 0773-2023

General technical requirements for ophthalmic B-type ultrasound diagnostic equipment

revise

YY/T 0773-2010、YY/T 0849-2011

This document specifies the requirements and test methods for ophthalmic B-type ultrasound diagnostic equipment. This document is applicable to ophthalmic B-type ultrasound diagnostic equipment, whose nominal ultrasound frequency range is usually between 10MHz and 50MHz.

September 15, 2024

14

YY/T 0841-2023

Periodic testing and post repair testing of medical electrical equipment

revise

YY/T 0841-2011

This document specifies the requirements for testing or periodic testing of medical electrical equipment and medical electrical systems (hereinafter referred to as ME equipment and ME systems) and their components before delivery, during maintenance, inspection, repair, and other services in accordance with GB 9706.1. This document does not specify the requirements for repair, component exchange, and changes to ME equipment or ME systems. This document applies to ME equipment and ME systems that comply with GB 9706.1, as well as their components. This document is not applicable for evaluating whether the design of ME devices, ME systems, or other devices complies with their relevant standards. This document is not applicable for the assembly of ME systems. Regarding the assembly of the ME system, please refer to Chapter 16 of GB 9706.1-2020.

September 15, 2025

15

YY/T 0851-2023

Medical anti thrombotic socks

revise

YY/T 0851-2011

This document specifies the requirements and test methods for medical anti thrombotic socks knitted from natural fibers and/or synthetic fibers. This document applies to anti thrombotic socks used as medical devices and to prevent venous thrombosis. This document does not apply to customized socks.

September 15, 2024

16

YY/T 0905-2023

Central compressed air source equipment for dentistry

revise

YY/T 0905.2-2013

This document specifies the requirements for the central compressed air source equipment providing dental air for dental treatment machines and various dental gas equipment in dental clinics, and describes the corresponding test methods. This document also specifies the quality requirements and testing methods for the air produced by the central compressed air source equipment for dental use, such as the requirements for the purification level of the air used for dental use. This document also specifies the information requirements provided by the manufacturer regarding the performance, installation, operation, and maintenance of central compressed air source equipment. This document only applies to central compressed air source equipment located outside the dental treatment room. This document does not apply to central compressed air source equipment and facility pipelines located in dental treatment rooms. This document does not include requirements for central compressed air source equipment for dental laboratory applications (such as CAD/CAM systems).

March 15, 2025

17

YY/T 0977-2023

Anesthesia and respiratory equipment - oropharyngeal airway

revise

YY/T 0977-2016

This document specifies the requirements for oropharyngeal airways made of plastic and/or rubber materials, including those with reinforced inserts made of plastic and/or metal materials. This document does not specify the flammability requirements for the oropharyngeal airway. This document does not apply to metal oropharyngeal airways and upper throat airways without internal and complete sealing devices.

September 15, 2024

18

YY/T 1021.2-2023

Dental extraction forceps - Part 2: Identification

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This document specifies the labeling of dental extraction forceps. This document applies to all dental extraction forceps.

September 15, 2024

19

YY/T 1021.3-2023

Dental extraction forceps - Part 3: Design

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This document specifies the design of dental extraction forceps. This document applies to all dental extraction forceps.

September 15, 2024

20

YY/T 1028-2023

Medical endoscope fiber endoscope

revise

YY/T 1028-2008、YY/T 0283-2007

This document specifies the requirements for medical fiber endoscopes and describes the corresponding test methods. This document is applicable to medical fiber endoscopes.

September 15, 2024

21

YY/T 1622.2-2023

Dentistry - Periodontal probes - Part 2: Labeling

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This document specifies the labeling of periodontal probes. This document applies to periodontal probes made of austenitic stainless steel or martensitic stainless steel. This document does not apply to periodontal probes made entirely of plastic at the working end, nor does it apply to HAUER probes and periodontal probes with adjustable detection force.

September 15, 2024

22

YY/T 1833.4-2023

Artificial intelligence - Quality requirements and evaluation of medical devices - Part 4: Traceability

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This document specifies the general requirements for traceability of artificial intelligence medical devices and describes the corresponding evaluation methods. This document applies to the traceability activities of the design and development process, usage process, and update process of artificial intelligence medical devices. This document is not applicable to the circulation process of artificial intelligence medical devices.

September 15, 2024

23

YY/T 1889-2023

Ophthalmic optics - Contact lens care products - Contact lens care products and contact lenses in lens boxes - Bacterial and fungal challenge assessment methods

formulate

/

This document describes an end point method for evaluating the compatibility of contact lens care products with disinfection functions with hydrogel lenses and lens boxes. This document applies to contact lens care products with disinfection functions. This document does not apply to nursing products that use hydrogen peroxide as the main antibacterial ingredient.

September 15, 2024

24

YY/T 1890-2023

Hepatitis B virus surface antigen detection kit (immunochromatographic method)

formulate

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This document specifies the requirements, test methods, labeling, labeling and instructions for use, packaging, transportation, and storage of the Hepatitis B Virus Surface Antigen Detection Kit (Immunochromatography). This document is applicable to the hepatitis B virus surface antigen detection kit that uses immunochromatography methods such as colloidal gold and latex to qualitatively detect hepatitis B virus surface antigen (HBsAg) in human serum, plasma, or whole blood. This document is not applicable to hepatitis B virus surface antigen detection kits using methods such as enzyme-linked immunosorbent assay, chemiluminescence immunoassay, and time-resolved immunofluorescence.

September 15, 2024

25

YY/T 1893-2023

Y-chromosome microdeletion detection kit

formulate

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This document specifies the requirements, test methods, labeling and user manual, packaging, transportation, and storage of the Y chromosome microdeletion detection kit. This document is applicable to Y chromosome microdeletion detection kits such as PCR fluorescence probe method, PCR capillary electrophoresis method, and biochip method. This document is not applicable to detection kits based on second-generation sequencing.

September 15, 2024

26

YY/T 1895-2023

Intravascular optical coherence tomography imaging equipment

formulate

/

This document specifies the requirements, test methods, accompanying documents, and markings for intravascular optical coherence tomography imaging equipment. This document applies to instruments and their attachments that use optical coherence tomography to perform tomography imaging of coronary arteries.

September 15, 2024

27

YY/T 1900-2023

Dentistry - Corrosion resistance of dental amalgam alloys

formulate

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This document specifies the allowable requirements for strength reduction caused by crevice corrosion in dental amalgam products that comply with ISO 24234 or ISO 20749, and provides detailed information on determining this test method.

September 15, 2024

28

YY/T 1901-2023

Requirements and test methods for orthopedic surgical navigation equipment using robot technology

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This document specifies the technical requirements for orthopedic surgical navigation equipment using robot technology (hereinafter referred to as orthopedic surgical navigation equipment) and describes the corresponding test methods. This document is applicable to navigation equipment for orthopedic surgeries (such as joint replacement surgery, spinal surgery, trauma orthopedics, etc.).

September 15, 2024

29

YY/T 1905-2023

Accuracy requirements for dose calculation of light ion beam radiotherapy plan

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This document specifies the requirements for the accuracy of dose calculation in light ion beam radiation therapy plans and describes the corresponding experimental methods. This document applies to light ion beam radiation therapy plans with a single nuclear energy range of 10MeV/n to 500MeV/n.

September 15, 2024

30

YY/T 1906-2023

Disposable sterile closure clip

formulate

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This document specifies the structure and materials, requirements, labels, and instructions for disposable sterile closure clips (hereinafter referred to as closure clips), and describes the corresponding test methods. This document is applicable to the closure of blood vessels or closed tubular tissues (including small and medium-sized arteries and veins, bile ducts, etc., not applicable to large arteries and veins) in surgical procedures. This document does not apply to metal clips, absorbable closure clips, continuous closure clips, temporary tissue or blood vessel clamping during surgery, or closure clips removed after surgery.

September 15, 2024

31

YY/T 1907-2023

Algorithm performance testing method for artificial intelligence medical device coronary artery CT image processing software

formulate

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This document describes the algorithm performance testing method for coronary artery CT image processing software using artificial intelligence technology. This document is applicable to software products that use artificial intelligence technology for post-processing coronary artery CT images. This document is not applicable to image preprocessing and process optimization.

September 15, 2024

32

YY/T 1908-2023

Nucleic acid extractor

formulate

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This document specifies the requirements, test methods, labeling, labeling and instructions for use, packaging, transportation, and storage of nucleic acid extractors. This document is applicable to automated pre-processing instruments for the extraction and purification of nucleic acids in clinical samples.

September 15, 2024

33

YY/T 1909-2023

Control and Confirmation Requirements for Electron Beam Melting Process of Metal Powder Bed in Medical Additive Manufacturing

formulate

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This document specifies the general requirements for routine control and process confirmation of metal material powder bed melt additive manufacturing processes using electron beams as energy sources. This document applies to the processing of medical devices manufactured using metal material powder bed electron beam melting technology.

September 15, 2024

34

YY/T 1910-2023

Medical use for additive manufacturing β- Tricalcium phosphate powder

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This document specifies the medical use for additive manufacturing β- Performance requirements, test methods, labeling, packaging, transportation, and storage of tricalcium phosphate powder. This document is applicable to the medical use of UV curing, extrusion, and powder additive manufacturing processes β- Tricalcium phosphate powder.

September 15, 2024

35

YY/T 1911-2023

Medical devices - Coagulation test methods

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This document describes the in vitro coagulation test method for medical devices/materials in contact with blood. This document is applicable to the testing of coagulation performance of medical devices/materials.

September 15, 2024

36

YY/T 1912-2023

Biological evaluation and testing of medical devices for soft tissue regeneration

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This document describes the biological evaluation and testing methods for soft tissue regenerative medical devices. This document is applicable for the biological evaluation of soft tissue regeneration medical devices based on GB/T (Z) 16886.

September 15, 2024

37

YY/T 1913-2023

Method for determination of residual 2,2-di (4-hydroxyphenyl) propane (bisphenol A) in medical polycarbonate materials

formulate

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This document describes a method for determining the residual amount of 2,2-di (4-hydroxyphenyl) propane (bisphenol A) in medical polycarbonate materials. This document is applicable to the determination of residual 2,2-di (4-hydroxyphenyl) propane (bisphenol A) in medical polycarbonate materials.

September 15, 2024

38

YY/T 1914-2023

General requirements for medical devices and appliances used in human assisted reproductive technology

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This document specifies the general requirements for medical devices and appliances used in human assisted reproductive technology, including requirements and test methods. This document is applicable to medical equipment and appliances used in human assisted reproductive technology, including assisted reproductive catheters, assisted reproductive puncture/sperm collection needles, and assisted reproductive micro tools.

September 15, 2024

39

YY/T 1915-2023

General rules for laboratory testing of immunochromatographic assay kits

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This document specifies the testing quality requirements for the laboratory during the performance verification process of the immunochromatographic reagent kit, including personnel, environment, instruments, as well as the requirements for testing process control and analysis of testing results. This document is applicable to testing laboratories for verifying the performance of immunochromatographic assay kits for in vitro diagnosis, including those of manufacturing enterprises.

March 15, 2024

40

YY/T 1916-2023

Interleukin-6 (IL-6) assay kit (labeled immunoassay)

formulate

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This document specifies the requirements, testing methods and labeling, labeling and instructions for use, packaging, transportation, and storage of the interleukin-6 (IL-6) assay kit (labeled immunoassay). This document is applicable to a reagent kit for quantitative determination of IL-6 content in human serum, plasma, or whole blood based on the principle of labeled immunity. The methodology includes fluorescence labeled immunochromatography, chemiluminescence, etc. This document is not applicable for the evaluation of IL-6 calibration and quality control products.

September 15, 2024

41

YY/T 1917-2023

Anti Xa assay kit (chromogenic substrate method)

formulate

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This document specifies the requirements, labeling, instructions for use, packaging, transportation, and storage of the anti Xa assay kit (chromogenic substrate method), and describes the corresponding test methods. This document is applicable to the anti Xa assay kit using chromogenic substrate method for quantitative detection of common heparin (UFH) and low molecular weight heparin (LMWH) in human plasma samples.

September 15, 2024

42

YY/T 1918-2023

Digital polymerase chain reaction analysis system

formulate

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This document specifies the classification, requirements, testing methods, labeling, labeling, and instructions for use of digital polymerase chain reaction analysis systems, as well as packaging, transportation, and storage. This document is applicable to devices that generate hundreds to millions of independent reaction units for nucleic acid samples in the form of single droplets or single nucleic acid molecules. The analysis system includes micro droplet generation modules, polymerase chain reaction modules, and micro droplet detection modules.

September 15, 2024

43

YY/T 1919-2023

Test method for imaging performance of contrast-enhanced ultrasound

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This document describes the test conditions and methods for the performance of ultrasound imaging equipment in contrast-enhanced ultrasound imaging. This document is applicable to ultrasound imaging equipment with contrast function. This document is not applicable to ultrasound imaging devices that use gastrointestinal enhancers for signal enhancement.

September 15, 2024

44

YY/T 1920-2023

Hemocompatibility test of dialyzer

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This document specifies the test methods for blood compatibility of dialyzers. This document is applicable to the blood compatibility test of medical devices such as blood dialyzers, blood filters, and blood concentrators mainly composed of hollow fiber membranes.

September 15, 2024

45

YY/T 1921-2023

Closed loop copper containing intrauterine device

formulate

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This document specifies the composition and type, requirements, manufacturer provided information, packaging, and expiration date of closed-loop copper containing intrauterine devices, and describes the corresponding test methods. This document applies to closed-loop copper containing intrauterine devices and their placers, which are placed in the uterine cavity of women for contraceptive purposes.

September 15, 2024