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ISO - 10555-4

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

active, Most Current
Organization: ISO
Publication Date: 1 November 2023
Status: active
Page Count: 24
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

10555-4
November 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)....
ISO 10555-4
June 15, 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.
ISO 10555-4
June 15, 2002
Sterile, Single-Use Intravascular 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. Note 1 Attention is drawn to ISO 11070, which specifies...
ISO 10555-4
June 15, 1996
Sterile, Single-Use Intravascular 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. NOTE 1 Attention is drawn to ISO 11070, which specifies...

References

This document references:
ASTM F640 - Standard Test Methods for Determining Radiopacity for Medical Use
Published by ASTM on October 1, 2020
These test methods cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography), and DEXA (dual...
This document references:
DIN 13273-7 - Catheter for medical use - Part 7: Determination of the x-ray attenuation of catheters; requirements and testing
Published by DIN on December 1, 2020
A description is not available for this item.
This document references:
ISO 10555-1 - Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements AMENDMENT 1
Published by ISO on November 1, 2017
A description is not available for this item.
This document references:
ISO 11070 - Sterile single-use intravascular introducers, dilators and guidewires AMENDMENT 1
Published by ISO on May 1, 2018
Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally...
This document references:
12417-1 - Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
Published by ISO on October 1, 2015
This part of ISO 12417 specifies requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge. VDDCPs are medical devices with various...
This document references:
ISO 25539-2 - Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
Published by ISO on September 1, 2020
This document specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information...
This document references:
80369-7 - Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
Published by ISO on May 1, 2021
This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic...
This document is referenced by:
BS ISO 16142-1 - TC - Tracked Changes (Redline) - Medical devices — Recognized essential principles of safety and performance of medical devices Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
Published by BSI on February 24, 2020
A description is not available for this item.
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