T/CSBM 0012-2021 Active Group standards

T/CSBM 0012-2021 Biomedical material element determination using wavelength dispersive X-ray fluorescence spectroscopy

T/CSBM 0012-2021 Biomedical material element determination using wavelength dispersive X-ray fluorescence spectroscopy

Publish Date: 2021-04-26 Implement Date: 2021-10-01 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 0012-2021
Standard Type: Group standards
Standard Status: Active
is_force_gb: no
CCS Name: -
ICS Name: Surgical implants, prostheses, and orthoses
Publish Date: 2021-04-26
Implement Date: 2021-10-01
Pages: 12 pages

Scope

Main Technical Content: 1. Samples 1.1 Sample Status: To ensure that the sample meets the requirements for X-ray spectroscopy testing, the sample can be prepared by grinding, polishing (e.g., using 240#~600# water sandpaper to gradually polish the surface to a roughness of about 0.8), machining the surface of metal materials and devices, or by glass melting (e.g., for bioglass materials) or powder compacting (e.g., for additive manufacturing-grade low-modulus titanium alloy powders and powdered orthopedic repair materials). 1.2 Sample Preparation Requirements 1.2.1 General Requirements: The basic operations of solid sample preparation, powder compacting, glass melting, liquid sample preparation, and thin-film sample preparation should comply with the requirements of GB/T 16597-2019. This document mainly provides guidance on how to choose among these methods. 1.2.2 For metal material samples (e.g., metal plates and rods), they should be cut accordingly (for smaller finished devices, cutting along the diagonal can be used to obtain the largest possible test surface), polished, and then tested. Alternatively, the composition of the cut surface can be tested to minimize the shadowing effect caused by surface unevenness on X-ray measurements. For wire materials or small irregular materials, it is recommended to use acid washing to prepare a smooth sample piece or block for main component testing. 1.2.3 Principles for Preparing Metal Device Samples 1.2.3.1 For finished metal devices, sample preparation should follow the guidelines in 1.2.1. For extremely irregular or small-sized samples, they can be melted into smooth sample pieces to minimize the consumption of finished devices by the supplier. It is advisable to first select the same batch of raw materials to explore melting conditions and confirm the method before proceeding with sample melting. Based on laboratory equipment conditions, determine a suitable sample-flux combination in advance and conduct m

Development Information

Pages: 12 pages

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