1.1 本性能规范规定了医疗专业用于提供经尿道膀胱引流方法的一次性非气囊导尿管（法国尺寸12至30，包括12至30）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），并且仅提供一次性使用的非无菌和无菌产品。非无菌导管应进行消毒。 1.2 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。抗菌涂层的安全性和有效性或将其纳入装置聚合物材料不在本规范的范围内。 1.3 表面经过化学处理以增强其润滑性的导管可根据本规范进行测试。 1.4 监管机构可能需要额外的信息，如临床数据，以支持本标准的主题产品。 1.5 除外责任- 用于非尿道导尿的导管，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。 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 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。 1.8 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, non-balloon- urinary catheter, French sizes 12 through 30 inclusive, used by the medical professions for providing a method of bladder drainage through 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 and sterile for single use only. The non-sterile catheters should be sterilized. 1.2 Catheters whose surface has been chemically treated to effect biocompatibility or microbial properties may be tested to this specification. The safety and effectiveness of antimicrobial coatings or their incorporation into device polymer materials are not within the scope of this specification. 1.3 Catheters whose surface has been chemically treated to enhance their lubricity may be tested to this specification. 1.4 Regulatory bodies may require additional information, such as clinical data, to support the subject products of this standard. 1.5 Exclusions— Catheters for non-urethral catheterization, such as for nephrostomy, suprapubic cystostomy, ureterostomy, gastrostomy, enemas, and so forth, are excluded from the scope of this specification. 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 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. 1.8 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.