T/CSBME 008-2019 Active Group standards

T/CSBME 008-2019 The Evaluation Method for Residual Non-Soluble Particles in Implantable Medical Devices Fabricated by Metal Powder Bed Fusion Additive Manufacturing Technology

Publish Date: 2019-11-15 Implement Date: 2020-03-01 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/CSBME 008-2019

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2019-11-15

Implement Date: 2020-03-01

Scope

Scope: This standard provides an evaluation method for residual insoluble particles in implantable medical devices manufactured by additive manufacturing based on metal powder bed fusion technology. This standard is applicable to implantable medical devices whose final products are manufactured by additive manufacturing or those that have completed additive manufacturing and post-processing, as well as the evaluation of the effectiveness of the cleaning process during the manufacturing process. This standard is not applicable to the evaluation of residual insoluble particles in medical devices that have been cleaned and reused. Note 1: This standard does not set acceptance criteria or acceptable limits for residual insoluble particles in additive manufacturing devices. Note 2: The method given in this standard is not the only method for determining the presence of residual insoluble particles in additive manufacturing devices. Note 3: Given the characteristics of each additive manufacturing technology and the challenges in post-processing, there may be other risks or considerations related to certain additive manufacturing technologies or materials that are not covered by this standard for other types of additive manufacturing devices. Main technical content: This standard provides an evaluation method for residual insoluble particles in implantable medical devices manufactured by additive manufacturing based on metal powder bed fusion technology. This standard makes corresponding provisions in several aspects, including terms and definitions, considerations for the cleanliness of metal powder bed fusion parts, evaluation methods, allowable limits for residual insoluble particles, Appendix A: Cleaning verification methods, and Appendix B: Design, post-processing, and cleaning considerations for implantable medical devices manufactured by additive manufacturing based on metal powder bed fusion technology.