T/CSBM 0039-2023 Active Group standards

T/CSBM 0039-2023 Degradable medical zinc alloy capillary tube material

Publish Date: 2023-04-24 Implement Date: 2023-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CSBM 0039-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2023-04-24

Implement Date: 2023-10-01

Scope

Main Technical Content: 5 Technical Requirements 5.1 Chemical Composition 5.1.1 The chemical composition of degradable medical magnesium alloy capillary tubes shall comply with the requirements specified in Table 2. Table 2: Chemical Composition 5.1.2 For other impurity elements not specified in Table 2, the content shall be in accordance with the relevant provisions of YS/T 1113. If the purchaser has special requirements, the two parties may negotiate separately. 5.1.3 The determination of analytical values shall use the rounding comparison method, and the rounding of numerical values shall be in accordance with the relevant provisions of GB/T 8170. The rounding digit shall be consistent with the limit value digit listed in Table 2. 5.2 Dimensions and Permissible Deviations 5.2.1 Specifications The specifications of degradable medical zinc alloy capillary tubes shall comply with the requirements specified in Table 3. Table 3: Specifications 5.2.2 Outer Diameter Deviation The outer diameter deviation of degradable medical zinc alloy capillary tubes shall be less than 0.01 mm. 5.2.3 Wall Thickness Deviation 5.2.3.1 The allowable wall thickness deviation of degradable medical zinc alloy capillary tubes shall be ±5%. 5.2.3.2 The wall thickness deviation of degradable medical zinc alloy capillary tubes shall meet Equation (1). 5.2.3.3 The rounding digit shall be three decimal places, and the rounding of numerical values shall be in accordance with the relevant provisions of GB/T 8170. Equation (1): (tmax - tmin)/(tmax + tmin) × 200% ≤ tang × 5% where: tmax — maximum wall thickness, mm; tmin — minimum wall thickness, mm; tavg — average wall thickness, mm. 5.2.4 Ovality The maximum difference between the maximum and minimum outer diameters measured at the same cross-section of degradable medical zinc alloy capillary tubes shall not exceed 0.01 mm. 5.2.5 Straightness The straightness of degradable medical zinc alloy capill