T/CSBM 0027-2022 Active Group standards

T/CSBM 0027-2022 Tri-Calcium Phosphate for Surgical Implants

T/CSBM 0027-2022

Publish Date: 2022-04-12 Implement Date: 2022-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Price: $ 20.00

Download

Basic Information

Standard Code: T/CSBM 0027-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2022-04-12

Implement Date: 2022-10-01

Pages: 12 pages

Scope

Main Technical Content: 1. Technical Requirements 1.1 Appearance: White solid powder, with no visible impurities or agglomeration, and uniform powder distribution. 1.2 Phase Composition and Content 1.2.1 According to quantitative X-ray diffraction analysis, the X-ray diffraction spectrum of the α-TCP crystal structure should comply with the ICDD PDF powder diffraction card No. 09-0348. There should be no significant peaks of other calcium phosphates or crystalline phases, nor any obvious non-crystalline substances. 1.2.2 The content of α-TCP crystalline phase should be no less than 95%. 1.3 Calcium and phosphorus atomic ratio: The elemental analysis of calcium and phosphorus should be consistent with the theoretical stoichiometry of α-TCP [α-Ca3(PO4)2], with a calcium (Ca)/phosphorus (P) atomic ratio of 1.50 ± 0.05. 1.4 Microelement content 1.4.1 The content of arsenic (As), cadmium (Cd), mercury (Hg), and lead (Pb) should comply with the requirements in Table 1. Table 1: Microelement Content Microelement Content Arsenic (As) ≤ 3 mg/kg Cadmium (Cd) ≤ 5 mg/kg Mercury (Hg) ≤ 5 mg/kg Lead (Pb) ≤ 30 mg/kg 1.4.2 Total Heavy Metal Content 1.4.2.1 The maximum allowable amount of total heavy metal content (calculated as Pb) is 30 mg/kg. 1.4.2.2 For metals or oxides not calculated as Pb, if their content exceeds 0.1%, it is recommended to list them in the package and attach a note. 1.5 Compressive Strength of Hydrate The hydrate formed by α-TCP in contact with water should have certain compressive strength, and the compressive strength of the hydrate should be tested according to its intended use. 1.6 Biological Activity α-TCP should be evaluated for biological activity based on the results of in vitro deposition of hydroxyapatite. 1.7 Biocompatibility α-TCP should be evaluated for biocompatibility based on the intended use of surgical implants. 2 Test Methods 2.1 Appearance Inspection The sample is placed in a wh