DIN Standards Committee Health Technologies
DIN EN ISO 10555-6
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015); German version EN ISO 10555-6:2017
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 6: Subkutan implantierte Ports (ISO 10555-6:2015); Deutsche Fassung EN ISO 10555-6:2017
Overview
This International Standard 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. Requirements, performance, and user safety issues related to non-coring needles are excluded. This document has been prepared by Technical Committee ISO/TC 84 (secretariat: DS, Denmark) in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" (secretariat: DIN). At DIN, the German Institute for Standardization e. V., the responsible committee is Working Committee NA 063-02-01 AA "Injektionssysteme" ("Injection systems") at DIN Standards Committee Medicine (NAMed). This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). The informative Annex ZA is attached to this version.
Document: references other documents
Responsible national committee
NA 176-04-01 AA - Catheters, drainages
Responsible european committee
CEN/TC 205 - Non-active medical devices
Responsible international committee
ISO/TC 84 - Devices for administration of medicinal products and catheters
