标准摘要
[中文适用范围]： ，确保产品在使用过程中的安全性和有效性。同时，该标准还对生产过程中的质量控制和检测程序进行了详细描述，为制造商和使用者提供了统一的技术依据。 ***此介绍可能不准确，请注意参考原文。 [外文原描述]： This document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components, where the catheter is placed in a body cavity or wound, surgically or percutaneously, for drainage of fluid or air to the exterior. The drainage catheter is left to drain naturally or connected to a suction source for faster tissue granulation. This document is not applicable to: a) suction catheters; b) tracheal catheters; c) urethral catheters; NOTE See ISO 20696. d) ureteral stents, biliary stents, and other stents; NOTE See ISO 14630 and ASTM F1828‑97 for stents requirements. e) drainage catheters placed in digestive tracts percutaneously with gastrostomy technique; f) neuraxial catheters used for removal of cerebrospinal fluid; NOTE See ISO 20698. g) enteral catheters used for removal of solutions or substances from the gastrointestinal tract; NOTE See ISO 20695. h) coatings.
英文名称Sterile drainage catheters and accessory devices for single use