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NEN-EN-ISO 10555-4

Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters

active, Most Current
Organization: NEN
Publication Date: 1 December 2023
Status: active
Page Count: 32
ICS Code (Syringes, needles and catheters): 11.040.25
scope:

This document specifies requirements for balloon dilatation catheters supplied sterile and intended for single use.

This document does not specify requirements for vascular stents (see ISO 25539-2).

NOTE Guidance on the selection of balloon materials is given in Annex G.

Document History

NEN-EN-ISO 10555-4
December 1, 2023
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters
This document specifies requirements for balloon dilatation catheters supplied sterile and intended for single use. This document does not specify requirements for vascular stents (see ISO 25539-2)....
July 1, 2013
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters
This part of ISO 10555 specifies requirements for balloon dilatation catheters supplied in the sterile condition, and intended for single use.
October 1, 2011
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters
This part of ISO 10555 specifies requirements for balloon dilatation catheters supplied in the sterile condition, and intended for single use.
August 1, 2002
Sterile, single-use intravascular catheters - Part 4: Balloon dilatation catheters
A description is not available for this item.
August 1, 1997
Sterile, single-use intravascular catheters - Part 4: Balloon dilatation catheters
Specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.

References

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