T/CSBM 0054-2024 Active Group standards

T/CSBM 0054-2024 Surgical Implant Material for Titanium-Zirconium Alloy Processing Material

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 0054-2024

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 classification and marking, requirements, test methods, inspection rules, marking, packaging, transportation, storage, and quality certificates, as well as order forms (or contracts) for titanium-zirconium alloy processing materials used in surgical implants. This document applies to titanium-zirconium alloy rods and wires for surgical implants. Main technical content: 3. Terms and definitions: There are no terms or definitions that need to be defined in this document. 4. Classification and marking: 4.1 Products are classified by their condition: annealed state (M) and processed state (R). 4.2 Products are classified by their diameter: rods and wires. 4.3 Product marking is expressed in the order of product name, condition, specification, and document number. Example: A product with a cold-processed state and a diameter of 10 mm is marked as: Ti15Zr Y 10 T/CSBM 0054—2024. 5. Requirements: 5.1 Materials: 5.1.1 Cast ingots used for product production shall be melted multiple times. The first melting can be carried out in a vacuum self-consumption arc furnace or a cooling bed furnace, and subsequent melting shall be carried out in a vacuum self-consumption arc furnace, with no elements added during the last melting. 5.1.2 No recycled titanium and titanium alloys shall be used as raw materials for casting ingots and processing materials. 5.1.3 Tungsten electrode arc welding shall not be used for self-consumption electrodes. 5.2 Chemical composition: 5.2.1 The chemical composition of the products shall comply with the provisions of Table 1. Table 1 Chemical composition Alloy nominal composition Chemical composition (mass fraction) % Main components Impurity elements Ti Zr Fe CHON Other elements Single total Ti-15Zr Balance 14.5~16.5≤0.25≤0.10≤0.008≤0.20≤0.05≤0.10≤0.40 5.2.2 For the reinspection by the buyer, the allowable deviations of the chemical composition of the products shall comply with the provisions of GB/T 3620.2. 5.3 Sha