1.1 本性能规范规定了医疗专业用于通过尿道提供膀胱引流方式的一次性球囊留置导管（法国尺寸12至26，包括12至26）的短期使用性能要求。该产品以各种尺寸和材料制造，如乳胶、硅树脂、橡胶和各种聚合物（以及它们的组合），并提供非无菌灭菌和无菌一次性使用。表面经过化学处理以影响生物相容性或微生物特性的导管可根据本规范进行测试。 1.2 表面经过化学处理以增强涂层润滑性的导管可根据本规范进行测试。 1.3 本规范中的附件包括详细信息，如本规范的设备或材料。 1.4 本规范中的附录包含的信息仅供参考，不是本规范的强制性部分。 1.5 监管机构可能需要额外的信息，如临床数据，以支持不同的设计特征。 1.6 以国际单位制表示的数值应视为标准。括号中给出的值仅供参考。 1.7 除外责任- 长期使用本产品（超过30天）会遇到，但并不常见，因此被视为本规范的例外。类似地，将此类导管用于非尿道插管（例如用于肾造口术、耻骨上膀胱造口术、输尿管造口术、胃造口术、灌肠术等）不在本规范的范围内。 同样，三根管腔导管，30 cm 3. 球囊导管和小儿导管，以及使用液体或凝胶增强其表面润滑性的导管。 1.8 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。 1.9 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。

1.1 This performance specification establishes performance requirements for the short-term utilization of a single-use, balloon-retention catheter, French sizes 12 through 26 inclusive, used by the medical professions for providing a means of bladder drainage by means of the urethra. The product is manufactured in various sizes and materials such as latex, silicone, rubber, and various polymers (as well as combinations of these) and is provided non-sterile for sterilization and sterile for single use only. Catheters whose surface has been chemically treated to effect biocompatibility or microbial properties may be tested to this specification. 1.2 Catheters whose surface has been chemically treated to enhance their lubricity with a coating may be tested to this specification. 1.3 The annexes in this specification include detailed information, such as apparatus or materials for this specification. 1.4 The appendixes in this specification contain information intended to provide guidance only and are not a mandatory part of the specification. 1.5 Regulatory bodies may require additional information, such as clinical data, to support different design features. 1.6 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only. 1.7 Exclusions— Long-term indwelling usage (over 30 days) is encountered with this product, but not commonly, and is therefore considered an exception to this specification. Similarly, the use of such catheters for nonurethral catheterization (such as for nephrostomy, suprapubic cystostomy, ureterostomy, gastrostomy, enemas, and so forth) is excluded from the scope of this specification. Likewise, three lumen catheters, 30-cm 3 balloon and pediatric catheters, and catheters whose surface has been enhanced for lubricity using liquids or gels. 1.8 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. 1.9 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.