T/FDSA 0136-2026 Active Group standards

T/FDSA 0136-2026 Biodegradable bone repair scaffold and its preparation technical specification Part 1: General requirements

Publish Date: 2026-03-26 Implement Date: 2026-04-26 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 0136-2026

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: 2026-03-26

Implement Date: 2026-04-26

Scope

This document specifies the terms and definitions of biodegradable bone repair scaffolds, product classification and naming, general material and performance requirements, test methods, production processes and quality control, as well as general requirements for sterilization, packaging, labeling, storage, transportation, and shelf life. This document applies to the design, development, production, inspection, and circulation of three-dimensional porous biodegradable bone repair scaffolds (hereinafter referred to as "scaffolds") used for bone defect repair and reconstruction in the fields of tissue engineering and regenerative medicine. For products containing active cells, tissue-derived components, or managed as drug-device combination products, this document may be referenced for implementation, but their special requirements are not within the scope of this document. The material matrices include but are not limited to: a) Polymer-based materials; b) Ceramic-based materials; c) Composite-based materials; d) Metal-based materials. This document does not apply to: — Non-degradable permanent bone implants; — Biological scaffolds not intended for bone tissue engineering; — Solid bone repair materials without three-dimensional porous structures; — In situ molding or injection-type bone repair materials in vivo.