Standards

YY/T 1972-2025 Pending

YY/T 1972-2025 Dentistry—Tissue punches

This document specifies the performance requirements, marking, and labeling information for soft tissue resection blades used with dental handpieces, and describes the corresponding test methods.
This document is applicable to soft tissue resection blades used in oral surgery implantation procedures for making incisions or resecting and removing gum tissue from the gums.

Publish Date: 2025-06-18

YY/T 1971.1-2025 Pending

YY/T 1971.1-2025 Dentistry—Portable dental equipment for use in non-permanent healthcare environment—Part 1:General requirements

This document specifies the general requirements for portable dental equipment used in non-permanent medical environments and describes the corresponding test methods.
This document applies to the design and manufacture of portable dental equipment for use in non-permanent medical environments, including portable dental treatment units, portable dental patient chairs, portable doctor's chairs, portable oral lamps, portable suction source devices, portable air compressors, and other portable dental equipment.
Note: Subsequent sections of this document specify special requirements for specific types of portable dental equipment used in non-permanent medical environments.
This document does not apply to non-mobile dental equipment that is not intended for use in non-permanent medical environments or is not designed for disassembly, folding, or packaging for transportation between non-permanent medical environments; wearable dental equipment (such as headlamps and magnifying glasses); mobile dental equipment; or portable dental equipment. Additionally, this document does not consider the requirements for non-mobile dental equipment that can be installed in mobile dental medical facilities (such as vehicle-mounted or container-type mobile dental clinics).

Publish Date: 2025-06-18

YY/T 1970-2025 Pending

YY/T 1970-2025 Lipoprotein-associated phospholipase A2 testing kit(Chemiluminescent immuoassay)

This document specifies the requirements, marking, labeling, and user instructions for lipoprotein-associated phosphatase A2 assay kits (chemiluminescence immunoassay), as well as their packaging, transportation, and storage. It also describes the corresponding testing methods.
This document applies to assay kits that quantitatively measure lipoprotein-associated phosphatase A2 in human serum and plasma using the chemiluminescence immunoassay principle (hereinafter referred to as "assay kits"), including chemiluminescence analysis kits with carriers such as microplates, tubes, magnetic particles, microbeads, and plastic beads.

Publish Date: 2025-06-18

YY/T 1969-2025 Pending

YY/T 1969-2025 Microalbumin testing kit(Immunoturbidimetry)

This document specifies the requirements, marking, labeling, and user manuals for the microalbumin assay kit (immunoturbidimetry), as well as its packaging, transportation, and storage. It also describes the corresponding testing methods.
This document is applicable to kits used for quantitative detection of albumin in human urine samples by immunoturbidimetry.

Publish Date: 2025-06-18

YY/T 1968-2025 Pending

YY/T 1968-2025 Software of human embryo preimplantation genetic testing for chromosome aneuploidy analysis

This document specifies the requirements for pre-implantation chromosomal aneuploidy analysis software and describes the corresponding testing methods.
This document is applicable to the analysis of low-depth high-throughput gene sequencing data of embryos obtained by adapted detection kits and gene sequencers, with the aim of determining whether the embryos have chromosomal aneuploidy and large-scale deletion or duplication abnormalities.

Publish Date: 2025-06-18

YY/T 1967-2025 Pending

YY/T 1967-2025 Bead-based flow cytometric analyzer

This document specifies the requirements, marking, labeling, and user instructions for flow cytometers, as well as their packaging, transportation, and storage, and describes the corresponding test methods.
This document applies to flow cytometers used in medical laboratories (hereinafter referred to as cytometers). Cytometers are based on flow cytometry technology and are used to perform qualitative and/or quantitative detection of various analytes, such as nucleic acids, proteins, polypeptides, and small molecular substances, in human samples.

Publish Date: 2025-06-18

YY/T 1966-2025 Pending

YY/T 1966-2025 Dentistry—Filling instrument with contra angle

This document specifies the requirements and testing methods for reverse angle fillers, which are used to repair teeth by employing polymer-based restorative materials and dental sealants. The document also stipulates the requirements for design, dimensions, and marking.
This document applies to reverse angle fillers used to repair teeth by employing polymer-based restorative materials and dental sealants.

Publish Date: 2025-06-18

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