1.1 本指南提供了确定可能直接或间接接触患者的医疗器械包装材料生物相容性的适当测试的信息。 1.2 本指南不适用于二级或三级包装材料。 1.3 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。 1.4 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 包装材料与医疗器械的兼容性是许多监管机构的要求。由于大多数医疗设备都是在人体内、周围或人体上使用或植入的，因此这些设备的好处必须大于风险。因此，与医疗器械接触的包装材料也必须进行评估，并确定其可安全用于人体，因为它们不会对器械的物理、化学或生物特性产生负面影响。该评估可能包括对包装材料相关经验的研究和实际测试。如果材料在特定作用下具有可证明的安全使用历史，且与设计中的包装相同，则此类评估可能会得出无需测试的结论。 5.2 医疗器械制造商决定是否需要进行适当的测试，并考虑器械/包装的相互作用（如有）。当需要有关包装生物相容性的筛选信息时，通常会进行供应商的细胞毒性测试。

1.1 This guide provides information to determine the appropriate testing for biocompatibility of medical device packaging materials that have the potential to contact the patient directly or indirectly. 1.2 This guide does not apply to secondary or tertiary packaging materials. 1.3 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. 1.4 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 The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since most medical devices are used or implanted in, around, or on the human body, the benefits of these devices must outweigh the risks. Therefore, the packaging materials that come in contact with the medical device must also be evaluated and determined to be safe for use with the human body in that they have no negative impact on the physical, chemical, or biological properties of the device. This evaluation may include both a study of relevant experience with, and actual testing of, packaging materials. Such an evaluation may result in the conclusion that no testing is needed if the material has a demonstrable history of safe use in the specific role that is the same as that of the package under design. 5.2 The medical device manufacturer determines the need for appropriate testing, with consideration of the device/package interactions, if any. When screening information is needed regarding the biocompatibility of the packaging, cytotoxicity testing from the supplier is typically performed.