T/BYXT 064-2024 Active Group standards

T/BYXT 064-2024 Rare earth zeolite antibacterial and adsorbent hemostatic gauze

Publish Date: 2024-12-25 Implement Date: 2024-12-25 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/BYXT 064-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical hygiene products

ICS Name: Surgical instruments and materials

Publish Date: 2024-12-25

Implement Date: 2024-12-25

Scope

Scope: This document specifies the terms and definitions, raw material requirements, classification and specification requirements, technical requirements, test methods, inspection rules, packaging, marking, transportation, storage, sales, and services for rare earth zeolite antibacterial adsorption hemostatic gauze. This document applies to rare earth zeolite antibacterial adsorption hemostatic gauze. Other medical gauzes may be used for reference. Main technical content: 6.1 Appearance: The gauze should have a uniform color and no obvious visible foreign substances or yarn shedding. The gauze sheets, blocks, pads, and rolls should be folded flat and should not have frayed edges or exposed stubble. 6.2 Performance indicators should meet the requirements of Table 2. Table 2 Item Indicator Ammonia absorption value a/(mmol/100g) ≥25 Liquid absorption capacity /(mg/100cm2) ≥500 Antibacterial rate Escherichia coli /(%) ≥99.0 Staphylococcus aureus /(%) ≥99.0 Candida albicans /(%) ≥99.0 In vitro coagulation time /(s) ≤180 a The ammonia absorption value is used as a reference indicator for the quality of the zeolite material contained in the product. 6.3 Sterility requirements: Rare earth zeolite antibacterial adsorption gauze supplied in a sterile form should undergo a validated sterilization process to ensure its sterility. The sterility requirements should comply with the provisions of YY/T 0615.1.