T/CSBM 0051-2024 Active Group standards

T/CSBM 0051-2024 The characterization of surface grafted with hyperbranched polylysine

Publish Date: 2024-11-25 Implement Date: 2025-04-01 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 0051-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2024-11-25

Implement Date: 2025-04-01

Scope

Scope: This document specifies the requirements and testing methods for the grafted surface of hyperbranched polylysine on titanium metal surfaces for medical device polymer materials. This document is applicable to the characterization of hyperbranched polylysine grafted on titanium metal surfaces for medical device polymer materials. For other substrate materials, the grafted surface of polylysine can be used as a reference. Main technical content: 3. Terms and definitions The following terms and definitions are applicable to this document. 3.1 Hyperbranched polylysine: A branched macromolecule prepared by condensation polymerization using lysine as the monomer, which has a three-dimensional hyperbranched structure. 3.2 Grafting: The process of chemically bonding hyperbranched polylysine to the surface of a substrate material using covalent bonds. 4. Requirements 4.1 Physicochemical properties 4.1.1 Identification The grafted surface elements are tested using X-ray photoelectron spectroscopy (XPS). The following requirements must be met to confirm the successful preparation of the grafted surface on the substrate: a) The atomic content of nitrogen (N) in the sample without the grafted surface of hyperbranched polylysine shall be ≤3%; b) The atomic content of nitrogen (N) in the sample with the grafted surface of hyperbranched polylysine shall be ≥8%. 4.1.2 Grafted surface thickness The grafted surface thickness shall meet the manufacturer's requirements. 4.1.3 Grafted surface morphology When applicable, the grafted surface morphology shall meet the manufacturer's requirements. 4.2 Antibacterial performance 4.2.1 General requirements Applicable when the purchaser requires the grafted surface of hyperbranched polylysine to have antibacterial properties. 4.2.2 Applicable bacteria The following bacteria are applicable: a) Escherichia coli (ATCC 8099); b) Staphylococcus aureus (ATCC 6538); c) Candida albicans (ATCC 10231)