医疗增材制造 一般原则 非活性植入物的增材制造

[中文适用范围]： 本文件旨在识别因采用增材制造技术而影响手术植入物安全性和性能的因素。本文件适用于非主动植入物（包括定制植入物和患者匹配植入物），这些植入物均通过增材制造技术生产。本文件也适用于与增材制造非主动手术植入物联合使用时的手术器械。尽管本文件不适用于主动植入物，但其中某些条款或子条款仍可能在主动植入物的上下文中使用。本文件识别了那些仅适用于增材制造植入物的因素，或需要对增材制造植入物进行额外考虑的因素。这些因素并未完全包含在现有的植入物特定标准中。本文件不适用于含有或结合动物或人体组织、细胞及其衍生物的植入物。 [外文原描述]： This document identifies factors that affect the safety and performance of surgical implants due to the fact that these implants are manufactured additively. This document applies to non-active implants manufactured additively, including custom-made implants and patient-matched implants. This document also applies to instrumentation for use in association with non-active surgical implants manufactured by additive manufacturing (AM). While this document is not intended to apply to active implants, certain clauses or subclauses of this document can potentially still be used in the context of active implants. This document identifies factors which are either unique to additively manufactured implants or which require additional consideration for additively manufactured implants. These factors have not always been included within existing implant specific standards. This document is not applicable to implants which contain or incorporate tissues or cells, or their derivates, of animal or human origin.