1.1这些试验方法涵盖了医疗专业人员通过自然孔口（鼻孔、口腔、腔内）和/或手术造口为患者提供营养和/或给药方式的一次性使用、带保留气囊的肠内喂养装置的使用性能要求的制定。该产品以各种尺寸和材料制造，如硅胶、聚氨酯和各种聚合物（以及它们的组合），并提供非无菌灭菌和一次性使用。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）。本标准的用户有责任在使用前制定适当的安全和健康实践，并确定监管限制的适用性。

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 and health practices and to determine the applicability of regulatory limitations prior to use.