1.1 这些测试方法涵盖了使用具有滞留气球的一次性肠内喂养设备的性能要求的制定，该设备由医疗专业人员用于通过自然口（鼻腔、口腔、腔内）和/或手术创建的造口为患者提供营养和/或给药。该产品以各种尺寸和材料制造，如硅树脂、氨基甲酸酯和各种聚合物（以及这些聚合物的组合），并提供非无菌灭菌和一次性无菌。这些测试方法的基本原理见 附录X1 。 1.2 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。 1.3 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。

1.1 These test methods cover the establishment of performance requirements for the utilization of a single-use, enteral feeding device with a retention balloon, used by medical professionals for providing a means of nutrition and/or administration of medication to patients by means of natural orifice (nasal, oral, transluminal) and or a surgically created stoma. The product is manufactured in various sizes and materials such as silicone, urethane, and various polymers (as well as combinations of these) and is provided nonsterile for sterilization and sterile for single use only. Rationale for these test methods can be found in Appendix X1 . 1.2 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. 1.3 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.