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现行 ASTM F2054/F2054M-13(2024)
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Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates 在限制板内部使用内部空气加压的柔性包装密封件爆破试验的标准试验方法
发布日期: 2024-11-01
1.1 本试验方法涵盖了在软包装内部加压并封闭在约束板内时,确定放置在软包装周边的密封件的最小爆破强度的程序。 1.2 本文描述的测试方法在功能上类似于测试方法 F1140 除了使用约束板。试验方法 F1140 描述了不包括使用约束板且适用于确定包装承受加压应力的一般能力的爆破试验方法。试验方法下 F1140 应力不均匀地分布到包装密封的所有区域。在无约束条件下,包装上的应力在袋的中间处最高,在那里它膨胀到包装的最大直径;因此,测试方法 F1140 可能无法可靠地检测密封的最薄弱区域。 1.3 爆裂测试对包装进行内部和递增的加压,直到围绕周边的包装密封的区域响应于加压而“爆裂”打开。通过在加压期间将包装放置在限制板内,包装的尺寸稳定性以导致沿包装的周边更均匀地施加应力的方式得以保持,其中通常放置密封件。这允许测试具有更高的概率来检测密封的最薄弱区域,并提供“爆裂”打开包装所需的压力的测量。 1.4 本试验仅适用于软包装(通常称为包装袋)周边有密封件的软包装。特别地,它旨在适用于具有可剥离密封特征(由最终用户剥离以移除包装内容物)的密封件的包装。 1.4.1 多孔屏障材料未能达到足以使包装密封破裂的压力可能是由于体积流量不足。见 附录X4 供参考。 1.5 以SI单位或英寸-磅单位表示的值应单独视为标准值。每个系统中陈述的值不一定完全等同;因此,为确保符合标准,每个系统应独立使用,两个系统的数值不得合并使用。 1.6 本标准并不旨在解决与其使用相关的所有安全性问题(如果有)。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。如果该程序的用户可能需要设计和制造约束板固定装置,建议特别小心。参考 附录X3 有关应力因子计算和结构设计考虑的更多信息。 1.7 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====== 5.1 当包装暴露于压差时,该测试提供了评估包装密封失效趋势的快速方法。在灭菌和运输等过程中可能会出现压差。该测试方法提供了包装破裂强度的指标,其中破裂通常发生在密封件的一个或多个区域。在确保足够的包装完整性方面,最小破裂强度的指示器对于包装制造商和最终用户可能是重要的。该测试方法不能提供包装密封均匀性的测量。该测试方法也不能评估包装的整体完整性或包装与所用约束板表面接触的区域的破裂强度。如果需要,该试验方法应与评价包装整体完整性、包装密封均匀性或开启功能的其他方法结合使用。 5.2 该测试经常用于在制造过程中和包装生命周期的各个阶段快速评估包装密封强度。5.3 如果要在测试设备之间建立相关性,测试的所有参数必须相等。典型的参数可以包括但不限于包装尺寸、材料、密封的类型和配置、进入包装的空气流量、压力检测传感机构和灵敏度(机器对压降的响应)、测试物品的位置、约束板的刚度和约束板之间的距离。见 附录X2 了解更多信息。 5.4 该测试不一定提供与通常使用测试方法测量的包装密封强度的相关性 F1140 或 F88 (或等同物)。
1.1 This test method covers the procedure for determining the minimum burst strength of a seal placed around the perimeter of a flexible package as it is internally pressurized and enclosed within restraining plates. 1.2 The test methods described herein are functionally similar to Test Methods F1140 with the exception of the use of restraining plates. Test Methods F1140 describes methods of burst testing that do not include the use of restraining plates and are suitable to determine a packages general ability to withstand pressurization stresses. Under Test Methods F1140 the stresses are not distributed uniformly to all areas of the package seal. Under unrestrained conditions the stress on the package is highest at the middle of the pouch where it inflates to the packages maximum diameter; therefore, Test Methods F1140 may not reliably detect the weakest area of the seal. 1.3 The burst test internally and increasingly pressurizes a package until an area of the package seal around the perimeter “bursts” open in response to pressurization. By placing the package within restraining plates during pressurization, the dimensional stability of the package is maintained in a manner that results in stresses applied more uniformly along the perimeter of the package, where seals are normally placed. This allows the test to have a higher probability of detecting the weakest area of the seal and provide a measurement of the pressure required to “burst” open the package. 1.4 This test only applies to flexible packages with seals placed around the perimeter of a flexible package (often referred to as a pouch). In particular it is intended as applicable to packages with seals that have a peelable seal feature (peeled open by end user to remove contents of package). 1.4.1 Porous barrier materials' failure to reach adequate pressure to burst the package seals may be due to insufficient volume flow. See Appendix X4 for information. 1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined. 1.6 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. Particular caution is advised where users of this procedure may be required to design and fabricate restraining plate fixtures. Reference Appendix X3 for further information regarding calculation of stress factors and structural design considerations. 1.7 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 This test provides a rapid means of evaluating tendencies for package seal failure when the package is exposed to a pressure differential. Pressure differentials may occur during such processes as sterilization and transportation. This test method provides an indicator of the burst strength of a package, where the burst will normally occur in one or more areas of the seal. An indicator of the minimum burst strength may be of importance to the package manufacturer and end user in ensuring adequate package integrity. This test method cannot provide a measure of package seal uniformity. This test method also cannot provide an evaluation of overall package integrity or the burst strength of areas of the package that contact the surface of the restraining plates used. This test method should be combined with other methods of evaluating overall package integrity, uniformity of the package seal, or opening functionality, if so required. 5.2 This test frequently is used to quickly evaluate package seal strength during the manufacturing process and at various stages of the package's life cycle. 5.3 If correlations between pieces of test equipment are to be made it is important that all parameters of the test be equivalent. Typical parameters can include, but are not limited to the package size, material, type and configuration of seal, rate of air flow into the package, pressure detection sensing mechanism and sensitivity (machine response to pressure drop), position of test article, rigidity of restraining plates, and distance between restraining plates. See Appendix X2 for further information. 5.4 This test may not necessarily provide correlation with package seal strength as typically measured using Test Methods F1140 or F88 (or equivalents).
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归口单位: F02.20
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