標(biāo)準(zhǔn)號：DIN EN ISO 20697-2018
中文標(biāo)準(zhǔn)名稱：一次性使用的無菌引流導(dǎo)管和輔助裝置(ISO 20697-2018); 德文版本EN ISO 20697-2018
英文標(biāo)準(zhǔn)名稱：Sterile drainage catheters and accessory devices for single use (ISO 20697:2018); German version EN ISO 20697:2018
標(biāo)準(zhǔn)類型：C47
發(fā)布日期：1999/12/31 12:00:00
實(shí)施日期：1999/12/31 12:00:00
中國標(biāo)準(zhǔn)分類號：C47
國際標(biāo)準(zhǔn)分類號：11.040.25
引用標(biāo)準(zhǔn)：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
適用范圍：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.