T/CAWAORG 037-2025 Active Group standards

T/CAWAORG 037-2025 Standard for Clinical Medical-Engineering Interaction Verification of Highly Adaptive Artificial Knee Joint under Enhanced Recovery Pathway

Publish Date: 2025-10-24 Implement Date: 2025-11-01 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/CAWAORG 037-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2025-10-24

Implement Date: 2025-11-01

Scope

This document is applicable to medical institutions, medical device enterprises, and scientific research units engaged in total knee joint replacement surgery and the development, production, and use of prostheses. It can also provide reference for other multi-center clinical trials and promotion and application. This document stipulates the medical-engineering interaction verification process centered on HC-TKA under the ERAS model, including but not limited to the allocation of responsibilities, document requirements, testing/verification methods, evaluation indicators, risk control, and information traceability for key stages such as preoperative planning, digital design, additive manufacturing, intraoperative implantation, postoperative follow-up, and closed-loop improvement.