On February 7, 2024, China NMPA released 20 Medical Device Industry Standards including YY 1001-2024 “All Glass Syringe”. The following is the detail information:
| No. | Standard No. | Title | Status | Scope of application | Effective Date |
| 1 | YY 1001—2024 | All glass syringes | Revised | This document specifies the structural type, materials, requirements, marking, packaging, transportation and storage of all-glass syringes and blue-core all-glass syringes and describes the corresponding test methods. This document applies to all-glass syringes and blue-core all-glass syringes. After the injection needle is installed on this product, it can be used for subcutaneous, intramuscular, and intravenous injection of medicinal liquids and extraction of liquids. | March 1, 2026 |
| 2 | YY/T 0062.1—2024 | Diagnostic X-rays for medical electrical equipment Part 1: Determination of equivalent filtration and intrinsic filtration | Revised | This document describes the methods for the determination of the inherent filtration and equivalent filtration of the filter material mass of an Instructions and declaration of conformity requirements for filter materials. This document applies to X-ray tube components and filter materials for high voltages up to 150kV in medical diagnostic applications. For high voltages greater than 50kV, this document only applies to X-ray tube assemblies with tungsten or tungsten alloy targets. | March 1, 2025 |
| 3 | YY/T 0323—2024 | Infrared thermal treatment equipment | Revised | This document specifies the requirements for infrared cautery therapy equipment and describes the corresponding test methods. This document applies to infrared thermal cautery therapy equipment. This document does not apply to infrared laser therapy equipment. | March 1, 2025 |
| 4 | YY/T 0331—2024 | Performance requirements and test methods for absorbent cotton gauze and absorbent cotton viscose blended gauze | Revised | This document specifies the performance requirements for absorbent cotton gauze and absorbent cotton viscose blended gauze and describes the corresponding test methods. This document applies to absorbent cotton gauze and absorbent cotton viscose blended gauze. This document does not apply to all gauze with viscose fiber yarns and gauze containing medicine. | March 1, 2025 |
| 5 | YY/T 0486—2024 | Requirements for marking and accompanying information of endotracheal tubes for laser surgery | Revised | This document specifies requirements for marking, labeling, and information provided by manufacturers of cuffed and uncuffed endotracheal tubes and related materials designed to withstand laser ignition. | March 1, 2025 |
| 6 | YY/T 0655—2024 | Dry chemistry analyzer | Revised | This document specifies the requirements, markings, labels, instructions for use, packaging, transportation, and storage of dry chemical analyzers (hereinafter referred to as analyzers) and describes the corresponding test methods. This document is applicable to analyzers that use solid-phase carrier reagents to perform chemical testing on patient blood, urine, cerebrospinal fluid and other samples in medical clinical settings. This document does not apply to glucose analyzers, urine analyzers, blood gas analyzers, or other dry analyzers. | March 1, 2025 |
| 7 | YY/T 0663.2—2024 | Cardiovascular Implantable Devices Intravascular Devices Part 2: Vascular Stents | Revised | This document specifies the general requirements, expected performance, design attributes, materials, design evaluation, post-market surveillance, production, sterilization, and packaging requirements for stent systems (vascular stents and delivery systems). This document applies to vascular stents (including absorbable vascular stents) for the treatment of vascular stenosis or other vascular abnormalities or lesions. This document applies to stents used in combination with endovascular prostheses to complete the treatment of lesions, including bridging stents (for example, stents placed in the renal artery after release of a fenestrated endovascular prosthesis), but does not describe the use of these stents in combination. Test Methods. This document applies to vascular stents with surface modifications (e.g., drugs and/or other coatings). This document applies to balloons included in stent systems. This document includes positioning devices, coil support devices, and flow-directing devices for local treatment of post-angioplasty dissection but does not provide a comprehensive description of the requirements and testing of these devices. This document applies to drug-eluting stents but does not provide a comprehensive description of the drug-eluting characteristics of these devices. This document applies to absorbable stents and absorbable-coated stents but does not provide a comprehensive description of the absorbable properties of these devices. This document applies to coated stents and coated stent systems but does not provide a comprehensive description of coating properties. This document does not apply to procedures and devices prior to vascular stenting, such as balloon angioplasty devices. This document does not apply to the requirements and evaluation of living tissue and non-living biomaterials used in the manufacture of vascular stents. | March 1, 2025 |
| 8 | YY/T 0853—2024 | Medical Varicose Vein Compression Stockings | Revised | This document specifies the requirements for medical varicose vein compression stockings (including custom-made stockings) knitted from natural and/or synthetic fibers and describes the corresponding test methods. This document applies to medical varicose vein compression stockings. | March 1, 2025 |
| 9 | YY/T 1200—2024 | Glucose determination kit (enzymatic method) | Revised | This document specifies the requirements, labeling and instructions for use, packaging, transportation and storage of glucose determination kits (enzymatic method) and describes the corresponding test methods. This document is applicable to the hexokinase method and glucose oxidase method determination kit, which is used for quantitative analysis of glucose concentration in serum, plasma, urine, cerebrospinal fluid and other body fluids in clinical testing. | March 1, 2025 |
| 10 | YY/T 1256—2024 | Ureaplasma urealyticum nucleic acid detection kit | Revised | This document stipulates the classification, technical requirements, labeling, instructions for use, packaging, transportation and storage of Ureaplasma nucleic acid detection kits, and describes the corresponding test methods. This document is applicable to nucleic acid detection kits for detecting Ureaplasma in the human urinary tract, reproductive tract and respiratory tract. The methodologies used include fluorescence PCR, isothermal amplification, and PCR membrane hybridization. | March 1, 2025 |
| 11 | YY/T 1549-2024 | Calibrators for biochemical analyzers | Revised | This document specifies the requirements, labels, instructions for use, packaging, transportation and storage of calibrators for biochemical analyzers, and describes the corresponding test methods. This document is applicable to calibrators used on fully automatic biochemical analyzers and semi-automatic biochemical analyzers for analysis of clinical testing items. This document does not apply to calibrators for electrolyte modules of biochemical analyzers. | March 1, 2025 |
| 12 | YY/T 1740.3—2024 | Medical Mass Spectrometers Part 3: Inductively Coupled Plasma Mass Spectrometers | Initiation | This document specifies the requirements, labeling, instructions for use, packaging, transportation and storage of medical inductively coupled plasma mass spectrometers, and describes the corresponding test methods. This document applies to medical inductively coupled plasma mass spectrometer (ICP-MS), which is mainly used to analyze inorganic elements in human samples, such as potassium, calcium, zinc, iodine, etc. | March 1, 2025 |
| 13 | YY/T 1766.4—2024 | Image quality evaluation method of X-ray computed tomography equipment Part 4: Imaging performance evaluation under automatic exposure control | Initiation | This document describes the corresponding imaging performance evaluation method when X-ray computed tomography equipment (hereinafter referred to as CT scanning device) adopts automatic exposure control technology. This document applies to whole-body and specialized CT scanning devices, including CT scanning devices that provide image data for radiation therapy planning. | September 1, 2025 |
| 14 | YY/T 1892—2024 | Breakpoint Cluster Region-Abelson Leukemia Virus ( BCR-ABL ) Fusion Gene Detection Kit | Initiation | This document specifies the requirements, labeling and instructions for use, packaging, transportation and storage of breakpoint cluster region-Abelsonian leukemia virus ( BCR-ABL ) fusion gene detection kits, and describes the corresponding test methods. This document is applicable to the detection of breakpoint cluster region-Abelson Leukemia virus ( BCR-ABL ) fusion gene detection kit in peripheral blood samples and bone marrow samples. The technical methods used include fluorescent polymerase chain reaction (Polymerase Chain Reaction, PCR) ) method, fluorescence reverse transcription polymerase chain reaction (Reverse Transcription-Polymerase Chain Reaction, RT-PCR) method, reverse transcription digital polymerase chain reaction (Reverse Transcription- Digital Polymerase Chain Reaction, RT- dPCR ) method and digital polymerase reaction (Digital Polymerase Chain Reaction, dPCR ) method, etc. | March 1 , 2025 |
| 15 | YY/T 1898—2024 | Test method for firmness of hydrophilic coating on intravascular catheter guidewires | Initiation | This document describes the coating firmness test method for medical catheter guidewires with hydrophilic lubricating coating used in blood vessels, including four methods: appearance inspection method, friction test method, insoluble particle test method, and chemical performance test method. The hydrophilic lubricating coating mentioned in this document only refers to the hydrophilic lubricating coating prepared by using polymers and chemically combined with the surface of the substrate, and does not include other types of coatings, such as drug-loaded coatings, degradable coatings, etc. This document applies to intravascular catheters and guidewires with hydrophilic lubricating coatings. | March 1 , 2025 |
| 16 | YY/T 1902—2024 | Medical plasma quick freezing machine | Initiation | This document stipulates the product classification and requirements of medical plasma quick freezing machines (hereinafter referred to as quick freezing machines), and describes the corresponding test methods. This document applies to medical plasma quick freezing machines. This document does not apply to quick freezers using heat transfer methods other than clamping and air-cooling. | 2 March 1, 2026 |
| 17 | YY/T 1903—2024 | Cardiac single photon emission computed tomography device performance and test rules | Initiation | This document specifies the performance of single photon emission computed tomography (SPECT) systems for cardiac tomography and describes the corresponding test methods. These systems include SPECT systems dedicated only to cardiac tomography, or general-purpose SPECT systems with a dedicated cardiac tomography subsystem that is outside the scope of the gamma camera standard for planar, whole-body, and SPECT imaging. | March 1 , 2025 |
| 18 | YY/T 1925—2024 | Cardiovascular Implantable Devices Neurovascular Thrombectomy Stents | Initiation | This document specifies the general requirements, expected performance, design attributes, materials, laboratory design evaluation, post-market surveillance, manufacturing, sterilization, and packaging requirements for neurovascular thrombectomy stents (referred to as thrombectomy stents). This document applies to thrombectomy stents intended to remove thrombus from neurovessels in patients with ischemic stroke, thereby restoring blood flow to the vessels. This document does not apply to other instruments and/or accessories that may be used during thrombectomy, such as balloon catheters, microguidewires, microcatheters, etc. | March 1 , 2025 |
| 19 | YY/T 1927—2024 | Sports medicine implant device strap loop fixation plate | Initiation | This document specifies the performance requirements for sports medicine implantable device loop fixation plates (hereinafter referred to as loop fixation plates), describes the corresponding test methods, and specifies the manufacturing, sterilization, biological safety evaluation, packaging and manufacturer information provided, etc. This document is applicable to the testing and evaluation of loop fixation plates used for fixation of soft tissue and bone or bone and bone. | March 1 , 2025 |
| 20 | YY/T 1929—2024 | Breast Biopsy and Rotation Equipment | Initiation | This document defines the terms and definitions of breast biopsy and rotational ablation equipment and rotational ablation needles, specifies materials and requirements, and describes corresponding test methods. This document applies to breast biopsy and rotational ablation equipment. | March 1 , 2025 |