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  • 22 05 2024

How to Submit Design Verification Data for Single-Use Sterile Closure Clips

It is recommended to detail the product's structural design in conjunction with the clinical requirements for the strength, toughness, and clamping stability of the closure clips. This should include the inner surface structure of the upper and lower arms, the dimensional parameters, connection structure, and locks. Please explain the basis for determining the structure and compare it with similar products already on the market.

  • 22 05 2024

How to Generally Evaluate Pyrogenicity Induced by Product Materials

According to the requirements of standard GB/T 16886.1-2022 Table A.1, all medical devices, except those that come into contact with intact skin and mucous membranes, need to be evaluated for material-induced pyrogenicity. The material-induced pyrogenicity evaluation data can be submitted in the following ways: comparison and analysis with previous products to demonstrate the biological risk equivalence of the product submitted for approval; providing chemical characterization, toxicological risk assessment data of raw materials and final products to prove the product does not contain known pyrogenic substances (as listed in GB/T 16886.11 Appendix G), thus exempting it from pyrogen testing; if during evaluation it is found that the product contains substances that have known pyrogenic reactions and/or new chemical components or substances with unknown pyrogen potential, further evaluation of the pyrogenicity of these components or substances is required, or a pyrogen test on the final product should be conducted.

  • 22 05 2024

Selection of Test Samples for Extractable Performance Study of Contact Lens Products

For the extractable performance study of contact lens products, finished lenses should be chosen for the extraction tests. The samples need to be representative; for example, for enhanced colored lenses, you can consider the type of dye and the total amount of the formulation. Considering the worst-case scenario, generally, lenses with the maximum total dye formulation that covers all types of dyes should be selected. If the lenses with the maximum total dye formulation do not cover all dye types, additional lenses that cover the remaining dye types should be included and subjected to separate extraction tests for validation.

  • 22 05 2024

If joint prosthesis products come with hydroxyapatite/metal composite coatings, what research data should be submitted

For joint prosthesis products with hydroxyapatite/metal composite coatings, you should typically submit research data on the composition of the hydroxyapatite/metal materials, the surface morphology of the composite coating (thickness, porosity, average pore diameter), and the mechanical properties of the composite coating (shear fatigue, shear strength, tensile strength, and wear properties). When studying the mechanical performance of the composite coating, it's suggested to clearly identify the failure modes for each test (e.g., whether the failure occurs between the coating and the substrate, or between layers of the coating). Since there are no standard test methods, you should provide the rationale for the chosen test methods, parameters, and equipment design. For the test results, ample supporting data should be provided to prove their clinical acceptability. For such composite coatings, the performance indicators detailed in the product's technical requirements should specify the bonding strength, tensile strength, surface quality, surface roughness, and thickness of the coating.

  • 22 05 2024

How to evaluate the performance of air filters in disposable infusion sets for preventing microbial entry

The mandatory industry standard GB 8368-2018 for disposable infusion sets states: "The venting device must have an air filter to prevent microorganisms from entering the container it is inserted into." However, the standard does not provide specific test methods for this performance indicator. It is recommended that when submitting a registration application for disposable infusion sets, you refer to the YY/T 1551 series standards and provide research data that demonstrates compliance with bacterial retention performance and integrity tests.

  • 22 05 2024

Selection of extraction solvents in the study of the extraction performance of contact lens products

It is recommended to select solvents according to Table 2 of GB/T 11417.7 "Test Methods for Physical and Chemical Properties of Contact Lenses." You should choose different types of solvents, including mild extraction solvent (e.g., distilled water), mildly extracting solvent (e.g., n-hexane), and strong extracting solvent (e.g., ethanol, etc.). If the recommended solvents in Table 2 are not applicable, you need to provide a study and justification for their inapplicability. In the application documents, you must provide the basis and validation data for the choice of solvents, demonstrating the suitability of the selected solvents. The validation should confirm that the chosen solvents are appropriate for the extraction performance study of the contact lens products.

  • 22 05 2024

To determine whether you can apply for a registration change to delete the main unit and keep only the accessories (consumables) to fit the needs of existing main units

First, you need to determine whether the remaining accessories can be considered as the same registration unit after deleting the main unit, according to the "Guiding Principles for the Division of Medical Device Registration Units." If feasible, you can apply for a change in registration to delete the main unit and keep the accessories while maintaining the original compatibility relationship. You will also need to modify the product name to match the accessories' name, and adjust the product's scope to clearly state that it is intended for use with the original main unit models. The product technical requirements should retain all relevant content to the accessories, as well as any performance indicators related to their use with the main unit.

  • 22 05 2024

Performance metrics typically specified in the technical requirements for posterior spinal rod and screw internal fixation systems

The performance metrics for posterior spinal rod and screw internal fixation systems usually include key dimensions and tolerances of pedicle screws (e.g., diameter), key dimensions and tolerances of connecting rods (e.g., diameter), hardness of parts other than the connecting rod, tensile strength of connecting rods and cross-links, surface quality (appearance, surface roughness, surface defects), compatibility performance, sterility (if applicable), and residual ethylene oxide levels (if applicable).

  • 22 05 2024

Types of endoscopic power equipment and main performance metrics

Endoscopic power equipment refers to devices driven by a power source to provide mechanical power to a tool head for grinding or cutting tissues during endoscopic surgeries. These devices can be categorized based on the tool head's functions such as shaving, grinding, and drilling. For example, there are devices for soft tissue shaving, devices for bone tissue grinding/drilling, and devices that combine both functionalities. The main performance metrics for these products should reference national and industry standards, taking into account clinical needs and the specific technical characteristics of the product. Equipment designed for shaving should comply with industry standard YY/T 0955 "Medical Endoscopes—Endoscopic Surgical Devices—Shavers." For other uses such as grinding and drilling, the metrics can be determined by referencing this standard combined with the product's characteristics.

  • 22 05 2024

Considerations for the production process of laser selective melting metal powder products

You need to outline the production and processing technologies for making metal powders, specifying key procedures, special processes, control points, and corresponding parameters. For the base material used in powder making, you should detail its common name, chemical name, standards and grades, material supplier, incoming inspection standards, and quality control requirements. Clearly define the main powder production processes like electrode induction melting gas atomization, plasma inert gas atomization, vacuum induction melting gas atomization, and plasma rotating electrode atomization. Specify critical process parameters like gas pressure, flow rate and temperature, the nozzle's inner diameter and spray angle, tower pressure and oxygen content during gas atomization, and current and rotation speed for the rotating electrode atomization process, along with the basis for determining these parameters. You should also define the processes for screening, mixing, and packaging the powder after making it, describing how to control these processes. Considerations should include how fine powder is removed during screening, atmospheric protection, pollution control, and explosion prevention measures. Additionally, study the compatibility of metal powder with key process parameters of the printing equipment. Essential parameters include laser power, scanning speed, spot diameter, scan spacing, scanning strategy, powder layer thickness, atmospheric protection, support structure, printing direction, and chamber temperature. Clearly define the worst-case performance of the metal powder and the parameter settings for the printing process.