The new quality management standard for additive manufacturing technology is ISO/ASTM 52920

The ISO/ASTM 52920 standard enables companies to achieve higher levels of safety, reliability and efficiency in their additive manufacturing processes, while meeting regulatory requirements. The standard plays a key role in striking a balance between innovation and quality and in increasing industrial competitiveness.

The rapid take-up of additive manufacturing technology in many areas of industry, particularly in medical device manufacturing, has brought new quality management requirements. The ISO/ASTM 52920 standard is a technology-specific new quality management standard for industrial additive manufacturing processes and represents a major milestone in the development of the regulatory framework. The presentation will describe the purpose and requirements of the standard, with a focus on the specific challenges of additive manufacturing, such as validation, traceability of raw materials and process safety in manufacturing. The presentation will also cover the areas of application of the standard and the steps for its practical implementation, in particular in the light of the regulation of medical devices.