1.1 本规程概述了如何对使用PBF/LB/M制造的医疗器械进行工艺验证。将涵盖的主题包括机器资格、制造过程中使用的软件、设计规范和验证对过程验证的重要性以及原材料。 1.2 本规程还为工艺表征、风险管理、增材制造（AM）设施鉴定和工艺控制提供了建议，作为鉴定活动的先决条件，包括安装鉴定/操作鉴定/性能鉴定（IQ/OQ/PQ）。 1.3 该实践主要集中在非设备特定的AM系统验证上。可能需要参考实际设备的性能的附加信息。 1.4 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者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. 5. 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 ====意义和用途====== 4.1 概述 4.1.1 产品质量的保证源于对许多因素的仔细关注，但不限于原材料验收、软件工作流程定义、产品和工艺设计与控制、打印和后处理、设备和系统的安装、维护以及- 过程和最终产品测试。 4.1.2 通过管理这些因素，制造商可以建立信心，确保连续批次的所有成品都是可接受的，并符合批次放行标准。 4.1.3 质量保证的基本原则以生产适合其预期用途的物品为目标。这些原则可以表述为: 4.1.3.1 质量、安全和有效性应设计并纳入产品和生产过程。 4.1.3.2 AM产品的所有特性目前都无法在没有破坏性测试的情况下在工艺后进行验证，因此需要验证。应在产品中设计适当的考虑因素，并在工艺验证过程中对工艺进行控制。 4.1.3.3 应控制生产过程中影响质量的关键步骤，以最大限度地提高成品满足所有质量和设计规范的可能性。 4.1.4 过程验证是确保实现这些QA目标的关键要素。 仅靠常规的最终产品测试往往不足以保证产品质量。一些最终产品测试的灵敏度有限。在某些情况下，需要进行破坏性测试来证明制造工艺是充分的，而在其他情况下，最终产品测试并不能揭示产品中可能发生的所有变化，这些变化可能会对设备性能产生影响。然而，成功验证一个过程可以减少对密集的过程中和成品测试的依赖。 请注意，在大多数情况下，最终产品测试在支持QA目标方面发挥着重要作用，即验证和最终产品测试并不相互排斥。 4.1.5 在适用的情况下，应使用统计过程控制对关键过程变量进行监测和记录。对从监测中收集的数据的分析应确定单个生产运行的工艺参数的潜在可变性，以确保工艺在可接受的控制范围内，并且设备能够始终如一地在规范范围内生产产品。 4.2 初步考虑: 4.2.1 制造商应通过适当的记录过程特征来评估影响产品质量的所有因素。 4.2.2 应根据ISO 14971创建风险管理和分析文件。这些因素在不同的产品、制造技术和设施之间可能有很大差异。在所有情况下，没有一种单一的工艺验证方法是适当和完整的；但是，应采取以下质量步骤。 4.2.3 在工艺验证过程中，应考虑对设备设计（产品的最终用途）有影响的生产工艺的所有相关方面。这些方面包括但不一定限于性能、可靠性和稳定性。应为每个特性验收标准确定性能限制和变化，并用易于测量的术语表示。一旦定义了产品规范，重要的是要根据文件化的变更控制程序和设备历史文件对其进行任何更改。

1.1 This practice provides an overview of how to perform process validation for medical devices manufactured using PBF/LB/M. The topics that will be covered include machine qualifications, software used in the manufacturing process, the importance of design specification and verification on process validation, and raw materials. 1.2 This practice also provides recommendations for process characterization, risk management, additive manufacturing (AM) facility qualification, and process control as a prerequisite for qualification activity, including installation qualification/operational qualification/performance qualification (IQ/OQ/PQ). 1.3 The practice is primarily focused on non-device-specific AM system(s) validation. Additional information may be needed in reference to the performance of the actual device. 1.4 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. 1.5 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 ====== 4.1 Overview: 4.1.1 Assurance of product quality is derived from careful attention to many factors but is not limited to raw material acceptance, software workflow definition, product and process design and control, printing and post processing, equipment and systems installation, maintenance, and in-process and end-product testing. 4.1.2 By managing these factors, a manufacturer can establish confidence that all finished manufactured units from successive lots will be acceptable and meet lot release criteria. 4.1.3 The basic principles of quality assurance (QA) have as their goal the production of articles that are fit for their intended use. These principles may be stated as: 4.1.3.1 Quality, safety, and effectiveness shall be designed and built into the product as well as the production process. 4.1.3.2 AM product characteristics all cannot currently be verified after the process without destructive testing and therefore requires validation. Suitable consideration should be designed into the product and controls should be applied to the process during process validation. 4.1.3.3 Critical steps of the production process impacting quality shall be controlled to maximize the probability that the finished product meets all quality and design specifications. 4.1.4 Process validation is a key element in ensuring that these QA goals are met. Routine end-product testing alone is often not sufficient to assure product quality. Some end-product tests have limited sensitivity. In some cases, destructive testing would be required to show that the manufacturing process is adequate, and in other situations, end-product testing does not reveal all variations that may occur in the product that may have an impact on device performance. However, successfully validating a process may reduce the dependence on intensive in-process and finished product testing. Note that, in most cases, end-product testing plays a major role in supporting QA goals, that is, validation and end-product testing are not mutually exclusive. 4.1.5 Key process variables should be monitored and documented using statistical process control where applicable. Analysis of the data collected from monitoring should establish the potential variability of process parameters for individual production runs to ensure that a process is within acceptable control limits and the equipment can consistently produce the product within specification. 4.2 Preliminary Considerations: 4.2.1 A manufacturer should evaluate all factors that affect product quality through appropriate documented process characterization. 4.2.2 Risk management and an analysis file shall be created in line with ISO 14971. These factors may vary considerably among different products, manufacturing technologies, and facilities. No single approach to process validation will be appropriate and complete in all cases; however, the following quality steps should be undertaken. 4.2.3 All pertinent aspects of the production processes that have an impact on device design (product’s end use) should be considered during process validation. These aspects include, but are not necessarily limited to, performance, reliability, and stability. Performance limits and variation should be established for each characteristic acceptance criteria and expressed in readily measurable terms. Once a product specification is defined it is important that any changes to it be made in accordance with documented change control procedures and the device history file.