T/CSBM 0031-2023 Active Group standards

T/CSBM 0031-2023 Animal-derived pericardial valve leaflet generic requirements

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 0031-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2023-04-24

Implement Date: 2023-10-01

Scope

Main Technical Content: 4.1 Physical Performance 4.1.1 The appearance should be free from stains, with a smooth surface and uniform color. Wrinkles, deep marks, wear, particles, tissue layering, blood vessel conditions, and other defects should be reasonably controlled. 4.1.2 Dimensions All dimensional values should comply with the manufacturer's specifications. 4.1.3 Tensile Strength The tensile strength should comply with the manufacturer's specifications. 4.1.4 Elongation The elongation should comply with the manufacturer's specifications. 4.1.5 Elastic Modulus The elastic modulus should comply with the manufacturer's specifications. 4.1.6 Suture Tensile Strength The suture tensile strength should comply with the manufacturer's specifications. 4.1.7 Heat Shrinkage Temperature The heat shrinkage temperature should meet the manufacturer's requirements. 4.1.8 Water Content in Tissue If applicable, the water content in the valve leaf should be tested, and its water content should meet the manufacturer's requirements. Note: This evaluation applies to valve leaves that have undergone a drying process. 4.2 Chemical Performance 4.2.1 pH Test The pH value of the pH testing solution and the pH value of the blank solution from the same batch should not differ by more than 1.5. 4.2.2 Total Heavy Metal Content The total content of heavy metals (calculated as Pb) in the testing solution should not exceed 1 μg/mL, and the cadmium content should not exceed 0.1 μg/mL. 4.2.3 Solvent Residue The allowable limits of residual cross-linking agents and other chemical additives involved in the valve manufacturing process should be established according to the method in GB/T 16886.17, and their content should meet the manufacturer's requirements. 4.3 Biological Performance 4.3.1 Biological Load The biological load should meet the microbiological limit requirements specified in the *Pharmacopoeia of the People's Republic of China* (202