T/CSBM 0048-2024 Active Group standards

T/CSBM 0048-2024 The evaluation method of biostimulation of calcium phosphate bioceramics in vivo

Publish Date: 2024-05-14 Implement Date: 2024-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Price: $ 20.00

Out of stock

Basic Information

Standard Code: T/CSBM 0048-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Medical materials

Publish Date: 2024-05-14

Implement Date: 2024-10-01

Scope

Scope: This document specifies the in vivo bone induction evaluation of calcium phosphate bioceramics in animal models, implantation tests, result determination, and reporting content. This document is applicable to the in vivo bone induction performance evaluation of calcium phosphate bioceramics; Main technical content: 5. Implantation tests 5.1 Experimental animal management shall be conducted in accordance with the requirements of GB/T 16886.2. 5.2 Sample preparation: The volume/mass of the implant should be consistent, and the implanted samples should be sterile. Note: For particle samples with a particle size of less than 1 mm, if the particles are made from a block that was crushed beforehand, the block-shaped sample before crushing can be used for the test. 5.3 Implantation operation: The implantation operation shall be conducted in accordance with the requirements of GB/T 16886.6. 5.4 Postoperative management 5.4.1 Observe the health status of the animals once a day after the surgery and record it. The health status of the animals can be determined by direct contact with the animals or observation outside the cage. If any abnormal clinical symptoms or inflammation and infection symptoms are observed, corresponding treatment and records should be carried out as soon as possible. 5.4.2 If the experimental animals die during the experiment, the final weight of the animals should be recorded, and the animals should be autopsied. The implant site and surrounding tissues should be removed and fixed until their potential use in histological research is determined. 5.5 Sampling method 5.5.1 Samples shall be taken at the designated time points. Before sampling, record the final weight, health status, and any abnormal conditions of each animal. 5.5.2 Related operations and animal welfare requirements shall be carried out in accordance with the requirements of GB/T 16886.2 and GB/T 16886.6. 5.6 Histological evaluation 5.6.1 After sampling, the samples shall be fixed u