T/CSBM 0029-2022 Active Group standards

T/CSBM 0029-2022 In vivo evaluation of implantable medical devices for repair or regeneration of articular cartilage tissue

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

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Basic Information

Standard Code: T/CSBM 0029-2022

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: 15 pages

Scope

Main Technical Content: 1. Basic Requirements: Users of this document should conduct cytotoxicity and biocompatibility tests on materials and/or devices before conducting the in vivo evaluation described in this document, in accordance with the requirements of GB/T 16886.1. Note 1: For specific products, some of the methods recommended in this document may not be fully applicable. In such cases, case-by-case analysis should be conducted based on the current status of technological development and relevant domestic and international guidelines. Note 2: The results of animal models may not fully predict the outcomes in humans, so their applicability in humans should be interpreted with caution. 2. Animal Models 2.1 Overview 2.1.1 This chapter provides considerations for selecting appropriate animal models and determining the size and location of articular cartilage defects, as detailed in Table 1. 2.1.2 Animal studies described in this document should comply with ethical and welfare requirements. Table 1: Animal Models for Evaluating Cartilage Tissue Repair Common Breeds Adult Age Adult Weight (kg) Common Defect Locations Femoral Condyle Cartilage Thickness (mm) Critical/threshold Defect Size (Diameter) (mm) Rabbit New Zealand White Rabbit 9 months 3–4 Femoral condyle, trochlea, tibial plateau, patella 0.25–0.75 5 Beagle, mixed breed 1–2 years 15–30 Femoral condyle, trochlea, patella 1.3 6 Mini-pig 10–12 months 20–40 Femoral condyle, trochlea, tibial plateau, patella 1.5–2.0 6 Sheep Suffolk, Texel 2–3 years 35–80 Femoral condyle, trochlea, tibial plateau, patella 1.7 Note: “-” indicates no relevant data available. 2.2 Joint Size and Load Selection 2.2.1 Human transparent joint cartilage injuries often occur in the knee joint, primarily in the medial portion (e.g., femoral condyle and tibial plateau). Therefore, it is advisable to select the knee joint for evaluating cartilage