T/CSBME 008-2019 Method for Assessing the Removal of Additive Manufacturing Residual Insoluble Particles in Implantable Medical Devices Fabricated by Metal Powder Bed Fusion (English Version)
This standard provides an evaluation method for residual insoluble particles in implanted medical devices manufactured using additive manufacturing based on metal powder bed fusion technology. This standard covers terms and definitions, considerations for cleanliness of metal powder bed fusion parts, evaluation methods, allowable residual insoluble particle limits, Appendix A cleaning verification methods, Appendix B metal powder bed fusion additive manufacturing implantable medical device design, post-processing Corresponding provisions are made in several aspects such as handling and cleaning considerations.
T/CSBME 008-2019 history
2019T/CSBME 008-2019 Method for Assessing the Removal of Additive Manufacturing Residual Insoluble Particles in Implantable Medical Devices Fabricated by Metal Powder Bed Fusion