DIN EN ISO 20697-2018 一次性使用的无菌引流导管和辅助装置(ISO 20697-2018); 德文版本EN ISO 20697-2018

标准号：DIN EN ISO 20697-2018
中文标准名称：一次性使用的无菌引流导管和辅助装置(ISO 20697-2018); 德文版本EN ISO 20697-2018
英文标准名称：Sterile drainage catheters and accessory devices for single use (ISO 20697:2018); German version EN ISO 20697:2018
标准类型：C47
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C47
国际标准分类号：11.040.25
引用标准：DIN 13273-7-2003;DIN EN ISO 10993-1-2010;DIN EN ISO 11135-2014;DIN EN ISO 11137-1-2015;DIN EN ISO 11137-2-2015;DIN EN ISO 11137-3-2017;DIN EN ISO 11607-1-2017;DIN EN ISO 11607-2-2017;DIN EN ISO 14155-2012;DIN EN ISO 14630-2013;DIN EN ISO 14971-2013;DIN EN
适用范围：This document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components. The drainage catheter is left to drain naturally or connected to suction source for faster tissue granulation. This document does not apply to: a) suction catheters; b) tracheal catheters;. c) uretheral catheters (see ISO 20696); d) Ureteral stents, biliary stents , and other stents (see ISO 14630 and ASTM F1828-97); e) drainage catheters placed in digestive tracts percutaneously with gastrostomy technique; f) neuraxial catheters used for removal of cerebrospinal fluid; g) enteral Catheters used for removal of solutions or substances from the gastrointestinal tract; h) coatings.