1.1 本标准为评估使用添加剂制造（AM）技术制造的医疗器械中的制造材料残留提供了指导，特别是使用粉末床融合AM技术制造的医疗器械。 1.1.1 本指南中讨论的一些技术可能适用于由其他类型的AM设备（例如，立体光刻）制造的器件。鉴于每种AM技术的特点和后处理挑战，可能存在与本指南未提及的某些AM技术或材料相关的额外风险或考虑因素。 1.2 本指南涵盖了几种定性和定量评估残留在粉末床融合AM医疗成分的水或有机溶剂中或通过提取获得的残留物的存在和数量。 1.2.1 本指南确定了定性确定残留存在的技术和定量评估残留的技术。它没有为残留在制造零件中的残留物设定验收标准或可接受限度。这些方法不是确定添加剂制造的医疗组件中残留材料的存在或数量的唯一方法。 1.3 本指南适用于处于成品状态（后处理和后续制造过程后）的设备。本指南也可用于评估制造过程中关键步骤之间清洁过程的有效性，以确保下游清洁过程中残留的AM最少。 1.4 本指南的目的不是评估已清洁以供再次使用的医疗组件中的残留水平。 1.5 不同的清洁方法，包括高能过程，可能会损坏AM零件中的小结构。本指南不涉及该风险的测量或缓解。 1.6 本指南不涉及处理小颗粒物（例如呼吸危害）的制造职业健康问题。 1.7 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.8 本标准并非旨在解决与其使用相关的所有安全问题（如有）。 本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.9 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 5.1 医疗器械中使用的材料的选择部分是因为其生物相容性，这意味着它们已被证明对预期应用具有可接受的生物反应。 在制造过程中，大多数设备暴露于各种加工步骤和材料中，如果在使用前未充分去除这些步骤和材料，则可能对设备的固有生物相容性产生不利影响。 注1: 对于细粉，根据应用情况，可能需要进行新的生物风险评估。 5.2 在加性制造中，组件在大多数情况下是逐层构建的，这使得设计复杂设备的自由度前所未有。这使得构建非常难以清洁的设备成为可能，例如拓扑优化零件、小内部通道、晶格结构，尤其是用于骨生长和固定的网状多孔结构。 5.3 粉末聚变AM提出了额外的挑战。组件从构建体积中出来，残余粉末填充设备内的所有开放空间。大多数多余的粉末通常通过振动摇动、压缩气体吹扫、抽真空和溶剂中的超声波清洗的组合来去除。然而，颗粒通常非常小，并可能滞留在内部特征中，例如孔隙，使去除变得困难。此外，在制造过程中直接与部件相邻的颗粒可以部分烧结到表面。这些颗粒极难去除，用大多数技术观察时无法与松散颗粒区分，并且在设备的预期使用过程中可能存在分离的风险。 5.4 本指南提供了测量残渣去除过程有效性的具体评估技术，因为它们应该能够产生一致的结果，满足预期用途的各自性能和清洁度标准。

1.1 This standard provides guidance for assessing the manufacturing material residues in medical devices fabricated using additive manufacturing (AM) techniques, specifically, from powder bed fusion AM technologies. 1.1.1 Some of the techniques discussed in this guide may be applicable to devices fabricated by other types of AM equipment (e.g., stereolithography). Given each AM technique’s characteristics and post-processing challenges, there could be additional risks or considerations associated with some AM techniques or materials that are not addressed by this guide. 1.2 This guide covers several qualitative and quantitative assessments of the presence and amount of residue remaining in or obtained by extraction in aqueous or organic solvents from powder bed fusion AM medical components. 1.2.1 This guide identifies techniques to qualitatively determine the presence of residue and a technique to quantitatively assess it. It does not set acceptance criteria or acceptable limits for residues remaining in built parts. These methods are not the only methods to determine the presence or quantity of residual material in additive manufactured medical components. 1.3 This guide pertains to devices in their finished state (after post-processing and subsequent manufacturing processes), as applicable. This guide may also be used to evaluate the effectiveness of cleaning processes between critical steps in the manufacturing process, to ensure minimal AM residue remains for cleaning processes downstream. 1.4 This guide is not intended to evaluate the residue level in medical components that have been cleaned for reuse. 1.5 Different cleaning methods, including high energy processes, can potentially damage small structures in AM parts. This guide does not address measurement or mitigation of this risk. 1.6 This guide does not address the manufacturing occupational health issues of working with small particles (e.g., breathing hazards). 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 5.1 Materials used in medical devices are selected in part for their biocompatibility, meaning that they have been demonstrated to have an acceptable biological response for the intended application. During manufacturing, most devices are exposed to a variety of processing steps and materials that have the potential to adversely affect the inherent biocompatibility of the device if they are not adequately removed prior to use. Note 1: For a fine powder, depending upon application, a new biological risk assessment may be required. 5.2 In additive manufacturing, components are in most cases built layer-by-layer, allowing unprecedented freedom to design complex devices. This makes it possible to build devices that are very difficult to clean, such as topological optimized parts, small internal channels, lattice structures, and especially reticulated porous structures for bone ingrowth and fixation. 5.3 Powdered fusion AM presents additional challenges. Components come out of the build volume with residual powder filling all open spaces within the device. The majority of the excess powder is typically removed by a combination of vibratory shaking, blowing with compressed gas, vacuuming, and ultrasonic cleaning in a solvent. However, the particles are typically very small and can become lodged in internal features such as pores, making removal difficult. Furthermore, particles that were immediately adjacent to the component during manufacturing can be partially sintered to the surface. Those particles can be extremely difficult to remove, are indistinguishable from loose particles when observed by most techniques, and may be at risk of detaching during the intended use of the device. 5.4 This guide provides specific evaluation techniques for measuring the effectiveness of residue removal processes, as they should be able to yield consistent results that meet the respective performance and cleanliness criteria for the intended use.