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About This Item

 

Full Description

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 10555-3:2013
EN ISO 10555-1:2013
ISO 10555-1:2013
EN ISO 10555-3:2013
ISO 5832-1:2016
ASTM F2182 - 11a
ASTM F2213 - 06
ISO 594-1:1986
ISO 9584:1993 (R08)
ISO 48:2010
ISO 10993-1:2009
ISO 11135-1:2007
ISO 5832-2:1999
ISO 7864:2016
ISO 17665-1:2006
ASTM F2119 - 07
ISO 6474-1:2010
ASTM F2052 - 06e1


Incorporates the following:
Amendment, November 2019
 

Document History

  1. BS EN ISO 10555-6:2017+A1:2019

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    Intravascular catheters. Sterile and single-use catheters-Subcutaneous implanted ports

    • Most Recent
  2. BS EN ISO 10555-6:2017


    Intravascular catheters. Sterile and single-use catheters-Subcutaneous implanted ports

    • Historical Version
  3. BS ISO 10555-6:2015


    Intravascular catheters. Sterile and single-use catheters. Subcutaneous implanted ports

    • Historical Version