Standards

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 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

YY 0989.6-2025 Pending

YY 0989.6-2025 Implants for surgery—Active implantable medical devices—Part 6:Particular requirements for active implantable medical devices intended to treat tachyarrhythmia(including implantable defibrillators)

This document specifies the requirements for active implantable medical devices (including implantable defibrillators) used in the treatment of tachyarrhythmia.
This document applies to implantable cardioverter-defibrillators, implantable cardiac resynchronization therapy/defibrillators, active implantable medical devices with the function of treating tachyarrhythmia, and certain non-implantable components and accessories of active implantable medical devices (see note).
This document does not apply to active implantable medical devices used in the treatment of bradyarrhythmia or cardiac resynchronization. GB 16174.2-2024 specifies such requirements.
Note 1: The tests specified in this document are type tests, and conformity is confirmed through testing of samples.
Note 2: The characteristics of implantable pulse generators or electrode leads are verified using appropriate methods described in this document or other methods, provided that the accuracy of these other methods can be proven to be equal to or superior to the specified methods. In case of dispute, the methods specified in this document shall prevail.
Note 3: What is commonly referred to as "active implantable medical devices" may actually be a single device, a combination of multiple devices, or a combination of one or more devices with one or more accessories. Not all of these components are partially or fully implantable, but if non-implantable components or accessories may affect the safety and performance of the implantable device, requirements for non-implantable components and accessories must be specified.

Publish Date: 2025-06-18

YY 0948-2025 Pending

YY 0948-2025 Cardiopulmonary bypass systems—Arteriovenous cannula for single use

This document specifies the requirements for single-use sterile arterial-venous catheters used for draining or perfusing blood during the implementation of cardiopulmonary bypass, extracorporeal lung assistance, left or right heart bypass, cardiopulmonary support, extracorporeal life support, extracorporeal carbon dioxide removal, and other extracorporeal circulation techniques, and describes the corresponding test methods.
This document applies to single-use sterile arterial-venous catheters used for draining or perfusing blood.
This document does not apply to:
——Guiding devices (such as guidewires) described in YY 0450.1—2020;
——Isolated organ perfusion catheters;
——Vascular intravascular catheters described in YY 0285.3—2017.

Publish Date: 2025-06-18