Intravascular catheters. Sterile and single-use catheters-Subcutaneous implanted ports
血管内导管 无菌和一次性导管
发布日期:
2019-11-05
ISO 10555的本部分规定了与在无菌条件下供应且一次性使用的血管内长期使用皮下植入端口和导管相关的要求、性能和用户安全问题。
ISO 10555的本部分未规定与非取芯针相关的要求、性能和用户安全问题。
注:皮下植入端口已知用于血管内以外的适应症,如腹膜内、鞘内、胸膜内和硬膜外通路。交叉引用:ISO 10555-3:2013EN ISO 10555-1:2013ISO 10555-1:2013EN ISO 10555-3:2013ISO 5832-1:2016ASTM F2182-11aASTM F2213-06ISO 594-1:1986ISO 9584:1993(R08)ISO 48:2010ISO 10993-1:2009ISO 11135-
1:2007ISO 5832-2:1999ISO 7864:2016ISO 17665-1:2006ASTM F2119-07ISO 6474-1:2010ASTM F2052-06E1包含以下内容:修订,2019年11月
This part of ISO 10555 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use.
This part of ISO 10555 does not specify requirements, performance, and user safety issues related to non-coring needles.
NOTE Subcutaneous implanted ports are known to be used for indications other than intravascular such as intra-peritoneal, intra-thecal, intra-pleural, and epidural access.Cross References:ISO 10555-3:2013EN ISO 10555-1:2013ISO 10555-1:2013EN ISO 10555-3:2013ISO 5832-1:2016ASTM F2182 - 11aASTM F2213 - 06ISO 594-1:1986ISO 9584:1993 (R08)ISO 48:2010ISO 10993-1:2009ISO 11135-1:2007ISO 5832-2:1999ISO 7864:2016ISO 17665-1:2006ASTM F2119 - 07ISO 6474-1:2010ASTM F2052 - 06e1Incorporates the following:Amendment, November 2019