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Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms 测定个人润滑剂与天然胶乳避孕套兼容性的标准试验方法
发布日期: 2023-09-01
1.1 本试验方法涵盖了用于检测天然橡胶胶乳(NRL)避孕套在浸入个人润滑剂后物理性能变化的程序。“个人润滑剂”是指消费者在使用避孕套时使用的液体或凝胶等润滑剂。 1.2 本试验方法不试图解决避孕套生产时使用的润滑剂(“制造商润滑剂”)的兼容性问题。避孕套制造商应负责验证包装在单个避孕套包装内的任何制造商润滑剂的长期稳定性(保质期)。其他监管要求可能适用。 1.3 以国际单位制表示的数值应视为标准。本标准中不包括其他计量单位。 1.4 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 已知天然橡胶胶乳在与某些润滑剂,特别是石油接触后会变弱- 基于产品。 3. , 4. 该程序被开发为润滑剂制造商的一种筛选方法,以确定特定的个人润滑剂是否对NRL避孕套的拉伸和空气爆裂性能有显著影响。 4.2 本试验方法适用于符合规范标准的NRL避孕套 D3492 并且可以: (1) 按照规范附录X1切割环形试样 D3492 和 (2) 按照规范附件A2的要求进行爆裂性能测试 D3492 。 4.3 本试验方法不用于确定试验润滑剂或NRL避孕套的安全性。本试验方法仅用于确定NRL避孕套的拉伸性能或空气爆裂性能是否受到试验润滑剂的显著影响。
1.1 This test method covers procedures used to detect a shift in physical properties of natural rubber latex (NRL) condoms after immersion in a personal lubricant. “Personal lubricants” are lubricants such as liquids or gels that are applied by the consumer at the time of condom use. 1.2 This test method does not attempt to address compatibility of lubricants applied to a condom at the time of manufacture (“manufacturer lubricants”). It shall be the responsibility of the condom manufacturer to verify the long-term stability (shelf life) of any manufacturer lubricant that is packaged within the individual condom wrapper. Other regulatory requirements may apply. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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 Weakening of natural rubber latex is known to occur after contact with certain lubricants, particularly petroleum-based products. 3 , 4 This procedure was developed as a screening method for lubricant manufacturers to determine whether or not a particular personal lubricant has a significant effect on the tensile and airburst properties of an NRL condom. 4.2 This test method is designed for use on NRL condoms that meet the criteria of Specification D3492 and can: (1) have a ring specimen cut in compliance with Appendix X1 of Specification D3492 and (2) be tested for burst properties in compliance with Annex A2 of Specification D3492 . 4.3 This test method is not to be used to determine the safety of either the test lubricant or NRL condom. This test method is to be used only to determine if the tensile or airburst properties of the NRL condom have been significantly affected by the test lubricant.
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归口单位: D11.40
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