T/CMBA 010-2020 Active Group standards

T/CMBA 010-2020 Evaluation specifications for implants for articular cartilage regeneration

Publish Date: 2020-07-23 Implement Date: 2020-07-23 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/CMBA 010-2020

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2020-07-23

Implement Date: 2020-07-23

Pages: 17 pages

Scope

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.