1.1 本指南提供了制定加速老化协议的信息，以模拟时间推移对ANSI/AAMI/ISO 11607-1:2019中定义的无菌屏障系统（SBS）的无菌完整性及其组件包装材料的物理特性的可能影响。制定加速老化协议的指南也可用于医疗器械和医疗器械材料。 1.2 在实时老化研究数据可用之前，使用本指南获得的信息可被视为医疗器械和无菌屏障系统有效期声明的充分证据。 1.3 加速老化指南将无菌屏障系统作为一个整体来处理，包括或不包括设备。本指南未涉及新产品开发或由此产生的评估可能需要的无菌屏障系统材料和设备相互作用兼容性。 1.4 本指南未提及实时老化协议；然而，必须进行实时老化研究，以使用相同的评估方法确认加速老化试验结果。实时老化（稳定性）是ANSI/AAMI/ISO 11607-1:2019的要求。 1.5 用于无菌屏障系统性能验证的方法，包括环境挑战、分配、处理和装运事件，用于包装性能（事件- 相关的完整性损失）测试，不在本指南的范围内。 1.6 本指南不涉及模拟运输和装卸环境中可能存在的极端气候条件的环境挑战。参考实践 D4332 用于在温度和湿度条件下挑战无菌屏障系统的标准条件。参见术语 17层 关于“环境挑战”的定义 1.7 从加速老化研究中获得的数据不得用作建立无菌屏障系统标签储存条件的方式。 1.8 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。 1.9 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。 1.10 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====== 4.1 无菌屏障系统完整性的丧失可能是由于材料的物理特性和粘合剂或内聚键随时间而退化，或由于运输和搬运过程中的后续动态事件，或两者兼而有之。加速实时老化仅验证了潜在完整性损失的时间相关方面。 4.2 ANSI/AAMI/ISO 11607-1:2019，第6.1.3款规定，“包装系统应提供物理保护，以保持无菌屏障系统的完整性。”第6.1.6款规定，“最终灭菌无菌屏障系统及其保护包装（如包括）的设计应确保在规定的加工、储存、搬运和分发过程中，通过暴露于预期条件和危险来保持无菌，直到SBS在使用点打开或直至到期日。 “第8.3.1款规定，“稳定性测试应证明无菌屏障系统随时间保持完整性。”第8.3.3款规定，“在实时老化研究数据可用之前，使用加速老化协议的稳定性测试应被视为声称有效期的充分证据。” 4.3 实时老化程序提供了最佳数据，以确保无菌屏障系统/医疗设备材料和无菌屏障系统/医疗设备的完整性不会随着时间的推移而退化。然而，由于产品可能在短时间内过时的市场条件，以及希望在尽可能短的时间内将新产品推向市场的愿望，实时老化研究无法满足这一目标。 加速老化研究可以为筛选SBS或医疗器械中可能的老化相关失效机制提供一种替代方法。为了确保加速老化研究代表实时效应，实时老化研究必须与加速研究并行进行。必须对产品的声称保质期进行实时研究，并完成研究。 4.4 如果对正在评估的无菌屏障系统材料知之甚少，则必须使用保守加速老化因子（AAF）。更具攻击性的AAF可与有文件证明的证据一起使用，以显示实时老化和加速老化之间的相关性。 4.5 在执行加速老化计划以确定到期日索赔时，必须认识到，从研究中获得的数据是基于模拟老化对材料影响的条件。由此产生的到期日或保质期是基于对老化因子的保守估计（即， Q 10 )在无菌屏障系统的实时老化研究结果完成之前，这是暂时的。 注1: 确定AAF超出了本指南的范围。 6.

1.1 This guide provides information for developing accelerated aging protocols to model the possible effects of the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1: 2019 and the physical properties of their component packaging materials. Guidance for developing accelerated aging protocols may also be used for medical devices and medical device materials. 1.2 Information obtained using this guide may be regarded as sufficient evidence for expiration date claims for medical devices and sterile barrier systems until data from real-time aging studies are available. 1.3 The accelerated aging guideline addresses sterile barrier systems as a whole with or without devices. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide. 1.4 Real-time aging protocols are not addressed in this guide; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation. Real-time aging (stability) is the requirement of ANSI/AAMI/ISO 11607–1: 2019. 1.5 Methods used for sterile barrier system performance validation, which include, environmental challenge, distribution, handling, and shipping events, are used for package performance (event-related loss of integrity) testing and are beyond the scope of this guide. 1.6 This guide does not address environmental challenging that simulates extreme climactic conditions that may exist in the shipping and handling environment. Refer to Practice D4332 for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. See Terminology F17 for a definition of “environmental challenging.” 1.7 The data obtained from accelerated aging studies is not to be used as a manner of establishing label storage conditions for sterile barrier systems. 1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.9 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. 1.10 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 The loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time or by subsequent dynamic events during shipping and handling, or both. Accelerated and real time aging verifies the time-related aspects of potential integrity loss only. 4.2 ANSI/AAMI/ISO 11607–1: 2019, sub-clause 6.1.3, states that “the packaging system shall provide physical protection in order to maintain integrity of the sterile barrier system.” Sub-clause 6.1.6 states that, “A terminally sterilized sterile barrier system with its protective packaging, if included, shall be designed to, maintain sterility through exposure to expected conditions and hazards during the specified processing, storage, handling, and distribution until that SBS is opened at the point of use or until the expiry date.” Sub-clause 8.3.1 states, “Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.” Sub-clause 8.3.3 states, “Stability testing, using accelerated aging protocols, shall be regarded as sufficient evidence for claimed expiry dates until data from real-time aging studies are available.” 4.3 Real time aging programs provide the best data to ensure that sterile barrier system/medical device materials and sterile barrier system/medical device integrity do not degrade over time. However, due to market conditions in which products may become obsolete in a short time, and the desire to get new products to market in the shortest possible time, real time aging studies do not meet this objective. Accelerated aging studies can provide an alternative means of screening for possible aging-related failure mechanisms in the SBS or medical device. To ensure that accelerated aging studies represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion. 4.4 Conservative accelerated aging factors (AAFs) must be used if little is known about the sterile barrier system material being evaluated. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. 4.5 When conducting accelerated aging programs for establishing expiry dating claims, it must be recognized that the data obtained from the study is based on conditions that simulate the effects of aging on the materials. The resulting creation of an expiration date or shelf life is based on the use of a conservative estimate of the aging factor (that is, Q 10 ) and is tentative until the results of real time aging studies are completed on the sterile barrier system. Note 1: Determining AAFs are beyond the scope of this guide. 6