Standards

YY/T 1965-2025 Pending

YY/T 1965-2025 Dentistry—Oral surgical scalpel handle

This document specifies the requirements and test methods for reusable surgical handles for oral surgery, such as cutting and/or removing oral soft tissues, which are connected to detachable surgical blades. This document also stipulates the marking and labeling requirements for such products.
This document applies to reusable surgical handles used in oral surgery.

Publish Date: 2025-06-18

YY/T 1964-2025 Pending

YY/T 1964-2025 Tacrolimus testing kit

This document specifies the requirements for tacrolimus assay kits, including identification, labeling, and user instructions, as well as packaging, transportation, and storage. It also describes the corresponding testing methods.
This document is applicable to kits used for quantitatively determining the tacrolimus content in human whole blood by chemiluminescent immunoassay, homogeneous enzyme immunoassay, immunoturbidimetry, and liquid chromatography-mass spectrometry.

Publish Date: 2025-06-18

YY/T 1963-2025 Pending

YY/T 1963-2025 Colorectal cancer related gene methylation detection kit(Fluorescent PCR )

This document specifies the requirements for methylation detection kits related to colorectal cancer, including labels, user manuals, packaging, transportation, and storage, and describes the corresponding testing methods.
This document is applicable to qualitatively detecting the methylation status of colorectal cancer-related genes in peripheral blood plasma and fecal samples, such as Septin9, SDC2, BCAT1, SFRP2, TFPI2, NDRG4, and BMP3.
This document is applicable to kits using methods such as fluorescence PCR and PCR fluorescence probe methods, but not to kits using high-throughput sequencing methods.

Publish Date: 2025-06-18

YY/T 1962-2025 Active

YY/T 1962-2025 Aldosterone testing kit (Chemiluminescent immunoassay)

This document specifies the technical requirements, marking, labeling, and user instructions for the aldosterone assay kit (chemiluminescence immunoassay), as well as its packaging, transportation, and storage, and describes the corresponding test methods.
This document is applicable to kits used for quantitatively measuring aldosterone in human serum or plasma based on the principle of chemiluminescence immunoassay.

Publish Date: 2025-06-18

YY/T 1961-2025 Pending

YY/T 1961-2025 Survival motor neuron gene(SMN) detection kit

This document specifies the requirements, marking, labeling, and user instructions for the motor neuron survival gene (SMN) detection kits, as well as their packaging, transportation, and storage, and describes the corresponding experimental methods.
This document is applicable to detection kits established by fluorescence quantitative PCR, PCR-fluorescence probe method, fluorescence PCR-capillary electrophoresis method, and fluorescence PCR melting curve method.

Publish Date: 2025-06-18

YY/T 1960-2025 Pending

YY/T 1960-2025 Medical devices—Information to be supplied by the manufacturer

This document specifies the requirements for the information provided by manufacturers of medical devices or accessories. This document includes general requirements for marking and labeling on the medical devices or accessories themselves and their packaging, as well as for the marking of medical devices or accessories and accompanying information. This document does not specify the method of providing information.
The requirements specified in medical device product standards or professional standards take precedence over the requirements of this document.
Note 1: Guidelines or explanations for this chapter can be found in Appendix A, section A.2.
Note 2: Certain regulatory authorities with jurisdiction may have requirements for the marking, labeling, and accompanying documents of medical devices or accessories that differ from the requirements of this document.

Publish Date: 2025-06-18

YY/T 1959-2025 Pending

YY/T 1959-2025 Particular specifications for digital intraoral X-ray imaging system

This document defines the terms and definitions of digital X-ray imaging systems in the oral cavity (hereinafter referred to as imaging systems), specifies their classification and components, sets out the requirements, and describes the corresponding test methods.
This document applies to imaging systems that use digital X-ray detectors with single-exposure imaging capabilities.
This document does not apply to:
— Intraoral imaging using film or light-stimulated phosphor imaging plates as X-ray receivers;
— Extraoral X-ray imaging systems.

Publish Date: 2025-06-18

YY/T 1958-2025 Pending

YY/T 1958-2025 17α-Hydroxyprogesterone testing kit(Labelling immunoassay)

This document specifies the technical requirements, marking, labeling, and usage instructions, packaging, transportation, and storage for the 17-alpha-hydroxyprogesterone assay kit (marked immunoassay), and describes the corresponding testing methods.
This document is applicable to immunoassay kits used for the quantitative determination of 17-alpha-hydroxyprogesterone in human serum, plasma, and heel prick blood (dried blood spots on filter paper) by methods such as enzyme marking, (electro)chemiluminescence marking, and (time-resolved) fluorescence marking.
This document is not applicable to:
a) immunoassay kits for immunochromatography;
b) calibrators and quality control products intended for separate sale.

Publish Date: 2025-06-18

YY/T 1945-2025 Pending

YY/T 1945-2025 Blood thawing device

This document specifies the requirements for blood thawing equipment (hereinafter referred to as thawing equipment) and describes the corresponding test methods. This document is applicable to thawing equipment that adopts the principle of constant temperature hydrolysis. This document is not applicable to plasma thawing equipment for preparing cold precipitation and thawing equipment that adopts microwave ovens, radio frequency methods, or dry hot air methods.

Publish Date: 2025-06-18

YY/T 1567-2025 Pending

YY/T 1567-2025 Female condoms—Requirements and test methods

This document specifies the minimum technical requirements for female condoms and describes the corresponding testing methods.
This document applies to female condoms provided to consumers for contraception and to help prevent sexually transmitted diseases.

Publish Date: 2025-06-18

YY/T 1488-2025 Pending

YY/T 1488-2025 Traditional Chinese medical device—Tongue features acquisition device

This document specifies the requirements for tongue image collection devices (hereinafter referred to as "devices") and describes the corresponding testing methods.
This document is applicable to tongue image collection devices.

Publish Date: 2025-06-18

YY/T 1274-2025 Pending

YY/T 1274-2025 Peritoneal dialysis equipment

This document specifies the requirements for peritoneal dialysis equipment and describes the corresponding test methods.
This document applies to peritoneal dialysis equipment (hereinafter referred to as "equipment").
This document does not apply to:
——Disposable consumables used during peritoneal dialysis (such as dialysis solution and dialysis solution pipelines);
——Continuous blood purification equipment;
——Hemodialysis equipment.

Publish Date: 2025-06-18