T/FDSA 0079-2025 Active Group standards

T/FDSA 0079-2025 Autologous Bone Tissue Bank

T/FDSA 0079-2025 Autologous bone tissue bank

Publish Date: 2025-05-26 Implement Date: 2025-06-28 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/FDSA 0079-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2025-05-26

Implement Date: 2025-06-28

Scope

Scope: This document specifies the general principles, quality management system, infrastructure and equipment, collection, processing, storage, packaging and sterilization, labeling and accompanying documents, distribution, use and disposal, confidentiality, and traceability of autologous bone tissue banks. This document applies to the management of autologous bone tissue banks. Main technical content: 6.2 Processing facilities and equipment 6.2.1 The processing of autologous bone tissue shall be carried out in a cleanroom (area) with a cleanliness level of not less than Class 10,000 to avoid contamination during production. The static pressure difference between cleanrooms (areas) with different cleanliness levels shall be greater than 5 Pa, and the static pressure difference between the cleanroom (area) and the outdoor atmosphere shall be greater than 10 Pa. Indicative pressure devices shall be installed. A suitable pressure gradient shall also be maintained between different functional areas (operating rooms) with the same cleanliness level. The processing site shall be reasonably laid out, including at least separate functional rooms for surface treatment, ultrasonic cleaning, inactivation, and internal packaging. 6.2.2 The cleanroom (area) shall be inspected and tested by a qualified third-party organization and found to be qualified. Regular monitoring and testing of the cleanroom (area) for dust particles, floating bacteria or settled bacteria, air exchange frequency or wind speed, static pressure difference, temperature, and relative humidity shall be carried out, and the monitoring records shall be preserved. The monitoring requirements shall be implemented in accordance with Table 1. **Table 1: Environmental Monitoring Requirements for Cleanrooms (Areas) in Autologous Bone Tissue Processing Sites** Monitoring Item Technical Specifications Monitoring Frequency Class 100 Class 10,000 Temperature, °C (unless otherwise specified) 18–28 1