T/CSBM 0045-2023 Active Group standards

T/CSBM 0045-2023 Calcium Sulfate Hemihydrate for Surgical Implants

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 0045-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2023-12-04

Implement Date: 2024-05-04

Pages: 11 pages

Scope

Scope: This document specifies the technical requirements, test methods, marking, packaging, transportation, and storage, as well as quality assurance requirements for semi-hydrated calcium sulfate used in surgical implants. This document applies to semi-hydrated calcium sulfate used in the preparation of surgical implants such as calcium sulfate bone cement, self-curing artificial bone, and bioactive composite materials for implantation in the human body. Main technical content: 5.1 Appearance: White solid powder, free from visible impurities or clumps, with uniform powder distribution. 5.2 Phase composition and content: 5.2.1 According to quantitative XRD analysis, the XRD spectrum of the semi-hydrated calcium sulfate crystal structure should comply with the ICDD's PDF powder diffraction card No. 41-0224. Except for CaSO4·2H2O or CaSO4, there should be no significant other crystal phase diffraction peaks or non-crystalline substances. 5.2.2 The content of the crystalline phase of semi-hydrated calcium sulfate measured according to 6.2 should not be less than 98%. 5.3 Calcium and sulfur atom ratio: The elemental analysis of calcium and sulfur should be consistent with the theoretical stoichiometry of semi-hydrated calcium sulfate (CaSO4·1/2H2O or CaSO4·H2O·CaSO4), with a calcium (Ca) and sulfur (S) atom ratio of 1.00 ± 0.05. 5.4 Elemental content: 5.4.1 The content of arsenic, bismuth, cadmium, mercury, lead, antimony, and iron in trace elements should comply with the requirements specified in Table 1. 5.4.2 Total heavy metal content: 5.4.2.1 The maximum allowable amount of total heavy metal content (calculated as Pb) is 30 mg/kg. 5.4.2.2 For metals or oxides not calculated as Pb, if their content is greater than or equal to 0.1%, they should be noted and listed in the packaging. 5.5 Hydrate compression strength: The hydrate compression strength should comply with the indicators provided in its technical specifications. 5.6 Curing time: The curing time should com