T/CMBA 010-2020 Active
T/CMBA 010-2020 Evaluation specifications for implants for articular cartilage regeneration
Abstract
Main technical content: This standard provides evaluation items for implants used in joint cartilage regeneration, as well as relevant reference standards and evaluation methods; the preparation process of tissue-engineered cartilage and the evaluation requirements of the final product; preclinical animal experimental research; and considerations for clinical research or clinical trials. This standard is applicable to regenerative implants intended for the treatment of joint cartilage injuries such as the knee and ankle, including various pure cartilage implant materials, cartilage repair membranes used in conjunction with microfracture techniques, and tissue-engineered cartilage combined with cartilage cells or mesenchymal stem cells derived from the human body.
General Product Information
| Document Type | Group standards |
|---|---|
| Standard Status | Active |
| Standard Code | T/CMBA 010-2020 |
| ICS | Surgical implants, prostheses, and orthoses |
| Implement Date | 2020-07-23 |