T/CSBM 0043-2023 Active Group standards

T/CSBM 0043-2023 Nutrition, protection, and oral equipment using sodium hyaluronate

Publish Date: 2023-12-04 Implement Date: 2024-05-04 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 0043-2023

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: 2023-12-04

Implement Date: 2024-05-04

Scope

Scope: This document specifies the requirements and test methods for sodium hyaluronate used in nursing, protection, and dental instruments. This document applies to sodium hyaluronate used in nursing, protection, and dental instruments. Dental instruments include wound dressings, scar repair dressings, oral/nasal dressings, and body cavity instrument lubricants, etc. Main technical content: 4.1 Appearance: Conduct the test according to 5.1. The test sample should be white or off-white granules, powders, or fibrous solids. 4.2 Identification: Conduct the test according to 5.2. The infrared absorption spectrum should be consistent with the reference spectrum. 4.3 pH value: Conduct the test according to 5.3. The pH value of a 5 mg/mL solution should be 5.0–8.5. 4.4 Solution appearance: Conduct the test according to 5.4. The solution S should be clear, and the absorbance value A600nm measured at a wavelength of 600 nm should not exceed 0.01. 4.5 Drying loss: Conduct the test according to 5.5. The drying loss of the test sample should not exceed 15.0% (mass fraction). 4.6 Heavy metal content: Conduct the test according to 5.6. The heavy metal content of the test sample should not exceed 10 μg/g. 4.7 Iron content: Conduct the test according to 5.7. The iron content of the test sample should not exceed 80μg/g. 4.8 Specific viscosity and molecular weight 4.8.1 The specific viscosity should be 90%–120% of the labeled value. 4.8.2 The molecular weight is calculated based on the specific viscosity. 4.9 Nucleic acid: Conduct the test according to 5.9. The absorbance value A260nm measured at a wavelength of 260 nm should not exceed 0.5. 4.10 Chloride content: Conduct the test according to 5.10. The chloride content of the test sample should not exceed 0.5%. 4.11 Protein content: Conduct the test according to 5.11. The protein content of the test sample should not exceed 0.1%. 4.12 Microbial limits: The total number of aerobic bacteria in each 1