Standards

YY/T 1833.5-2024 Active

YY/T 1833.5-2024 Artificial intelligence medical device—Quality requirements and evaluation—Part 5:Pre-trained models

This document specifies the general quality requirements for pre-trained models used in artificial intelligence medical devices and describes the corresponding evaluation methods.
This document applies to pre-trained models used in artificial intelligence medical devices.
This document does not apply to the evaluation of the R&D process of pre-trained models.

Publish Date: 2024-09-29

YY/T 1686-2024 Active

YY/T 1686-2024 Medical electrical equipment employing robotic technology—Terminology,definitions and classification

This document defines the terms and definitions of medical electrical equipment (hereinafter referred to as robotic equipment) or medical electrical systems (hereinafter referred to as robotic systems) that adopt robotics technology, and stipulates their classification.

Publish Date: 2024-09-29

YY/T 1585-2024 Active

YY/T 1585-2024 25-Hydroxyl vitamin D testing kit

This document specifies the requirements, marking, labeling, and user instructions for 25-hydroxy vitamin D assay kits, as well as their packaging, transportation, and storage, and describes the corresponding testing methods.
This document is applicable to the quantitative detection of total 25-hydroxy vitamin D, 25-hydroxy vitamin D2, and 25-hydroxy vitamin D3 in human serum or plasma using assay kits, including labeled immunoassays (such as enzyme-labeled and luminescence-labeled assays), immunoassay chromatography, immunoturbidimetry, and liquid chromatography-tandem mass spectrometry, among others.

Publish Date: 2024-09-29

YY/T 1529-2024 Active

YY/T 1529-2024 ELISA analytical instruments

This document specifies the requirements, marking, labeling, and user manuals for enzyme-linked immunosorbent assay analyzers (hereinafter referred to as analyzers), as well as their packaging, storage, and transportation. It also describes the corresponding test methods.
This document applies to enzyme-linked immunosorbent assay (ELISA) analyzers that use the ELISA method and the Lambert-Beer law as measurement principles to conduct quantitative or qualitative analysis of target substances. These analyzers typically include detection modules, reagent addition modules, incubation modules, and cleaning modules, among others.

Publish Date: 2024-09-29

YY/T 1284-2024 Active

YY/T 1284-2024 Dentistry—Dental tweezers

This document specifies the general requirements for dental forceps and describes the corresponding test methods.
This document is applicable to single-curved and double-curved metal dental forceps.
This document is not applicable to dissection forceps and medical forceps.

Publish Date: 2024-09-29

YY/T 1233-2024 Active

YY/T 1233-2024 Cardiac troponin detection reagent kit(labelling immunoassay)

This document specifies the requirements for myocardial troponin assay kits (labeled immunoassay), including identification, labeling, and user manuals, as well as packaging, transportation, and storage, and describes the corresponding test methods.
This document is applicable to kits used for the quantitative detection of myocardial troponin I (hereinafter referred to as cTnI) and myocardial troponin T (hereinafter referred to as cTnT) in human serum, plasma, or whole blood in vitro. The methods include enzyme-linked immunosorbent assay (ELISA), enzymatic and non-enzymatic chemiluminescence, electrochemiluminescence, and time-resolved fluorescence immunoassay, etc.

Publish Date: 2024-09-29

YY/T 1183-2024 Active

YY/T 1183-2024 Detection reagent kit for enzyme-linked immunoabsorbent assay

This document specifies the requirements, marking, labeling, and usage instructions for enzyme-linked immunosorbent assay (ELISA) test kits, as well as their packaging, transportation, and storage. It also describes the corresponding testing methods.
This document applies to quantitative or qualitative detection kits (hereinafter referred to as "test kits") that use ELISA as the principle for testing in medical laboratories.

Publish Date: 2024-09-29

YY/T 0866-2024 Active

YY/T 0866-2024 Total inward leakage(TIL) determination method of protective face mask for medical use

This document describes the test method for the total leakage rate of medical protective masks. This document is applicable to the evaluation of the total leakage rate of medical protective masks (hereinafter referred to as masks). For the evaluation of the leakage rate of other medical biological protective devices, this document can be used as a reference.

Publish Date: 2024-09-29

YY/T 0860-2024 Active

YY/T 0860-2024 Radio frequency ablation instrument for cardiac application

This document specifies the classification and requirements of cardiac radiofrequency ablation therapy equipment (hereinafter referred to as the equipment) and its accessories, and describes the corresponding test methods.
This document applies to cardiac radiofrequency ablation therapy equipment and its accessories. This type of equipment is used in cardiac interventional radiofrequency ablation surgery or cardiac/thoracic surgery radiofrequency ablation surgery.

Publish Date: 2024-09-29

YY/T 0802.2-2024 Active

YY/T 0802.2-2024 Processing of medical device—Information to be provided by the medical device manufacturer—Part 2:Non-critical medical devices

This document specifies the requirements for the information provided by medical device manufacturers regarding the handling of low-risk medical devices (i.e., medical devices that only come into contact with intact skin or medical devices that do not directly contact patients).
This document applies to the information required for handling medical devices before they are used or reused.

Publish Date: 2024-09-29

YY/T 0802.1-2024 Active

YY/T 0802.1-2024 Processing of medical devive—Information to be provided by the medical device manufacturer—Part 1:Critical and semi-critical medical devices

This document specifies the requirements for the information provided by medical device manufacturers regarding the handling of highly dangerous medical devices (i.e., medical devices that enter the normal sterile parts of the human body, or medical devices that come into contact with mucous membranes or incomplete skin) or medical devices prepared for sterilization.
This document applies to the information provided for the handling of medical devices before they are used or reused.

Publish Date: 2024-09-29

YY/T 0787-2024 Active

YY/T 0787-2024 Ophthalmic instruments—Corneal topographers

This document specifies the minimum requirements for corneal topography instruments and systems, the accompanying documents and markings, and describes the corresponding testing methods.
This document applies to instruments or systems used to measure the surface shape of the human eye's cornea.
Note: The measurement results may include the surface curvature of a localized area, the dimensions of the surface's three-dimensional topography, or other more comprehensive parameters used to characterize the surface features.
This document does not apply to corneal curvature meters in ophthalmic instruments.

Publish Date: 2024-09-29