Recently, the National Group Standards Information Platform released the fifth batch of additive manufacturing medical device group standards, including the standard “Additively Manufactured Metal Augments for Joint-End Bone Defects” (Standard No.: T/CAMDI 112—2023), which was jointly drafted with the participation of Guangzhou Sailong Additive Manufacturing Co., Ltd. (hereinafter referred to as “Sailong Additive”). The standard was officially implemented on December 31, 2023.

The newly released group standard “Additively Manufactured Metal Augments for Joint-End Bone Defects” specifies the terms and definitions, requirements, test methods, manufacturing, cleaning, sterilization, packaging, and information to be provided by the manufacturer. This standard applies to titanium alloy and tantalum metal augments for joint-end bone defects manufactured using powder bed fusion additive manufacturing processes with either laser or electron beam as the energy source.

The metal augments for joint-end bone defects covered by this standard are applicable to bone defects in hip, knee, shoulder, and elbow joints, but are not applicable to the spine, oral, cranio-maxillofacial, or cranial areas, nor to augments made of biodegradable metallic materials.

The release of this group standard contributes to the establishment of a standardized system for additive manufacturing medical devices, enhances the level of standardization in industry R&D and production, and makes a positive contribution to the healthy development of both the medical device sector and the additive manufacturing industry.