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DIN EN ISO 10555-1

Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013)

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Organization: DIN
Publication Date: 1 November 2013
Status: inactive
Page Count: 33
ICS Code (Syringes, needles and catheters): 11.040.25
scope:

This part of ISO 10555 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.

It is not applicable to intravascular catheter accessories, e.g. those covered by ISO 11070.

Document History

DIN EN ISO 10555-1
December 1, 2022
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO/DIS 10555-1:2022); German and English version prEN ISO 10555-1:2022
A description is not available for this item.
DIN EN ISO 10555-1
April 1, 2018
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013 + Amd 1:2017) (includes Amendment A1:2017)
This part of ISO 10555 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application. lt is not applicable to...
DIN EN ISO 10555-1/A1
March 1, 2016
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements - Amendment 1 (ISO 10555-1:2013/DAM 1:2016); German and English version EN ISO 10555-1:2013/prA1:2016
A description is not available for this item.
DIN EN ISO 10555-1
November 1, 2013
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013)
This part of ISO 10555 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application. It is not applicable to...
DIN EN ISO 10555-1
September 1, 2009
Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)
A description is not available for this item.
DIN EN ISO 10555-1/A1
February 1, 2009
Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995); English version prEN ISO 10555-1:2008, Amendment 1
A description is not available for this item.
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References

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 references:
ISO TS 12417 - Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products
Published by ISO on June 1, 2011
This Technical Specification 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 80369-1 - Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
Published by ISO on November 1, 2018
This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or...
This document references:
ISO 7886-1 - Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
Published by ISO on May 1, 2017
This document specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended...
This document is referenced by:
DIN EN ISO 11070 - Sterile intravaskulaere Einfuehrungsinstrumente, Dilatatoren und Fuehrungsdraehte zur einmaligen Verwendung (ISO 11070:2014 + Amd 1:2018); Deutsche Fassung EN ISO 11070:2014 + A1:2018
Published by DIN on April 1, 2019
A description is not available for this item.
This document is referenced by:
DIN EN ISO 11070 - Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014 + Amd 1:2018) (includes Amendment :2018)
Published by DIN on April 1, 2019
A description is not available for this item.
This document is referenced by:
DIN EN 13718-2 - Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances (includes Amendment A1:2020)
Published by DIN on October 1, 2020
A description is not available for this item.
This document is referenced by:
DIN EN ISO 25539-1 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017)
Published by DIN on May 1, 2018
This document specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information...
This document is referenced by:
DIN EN ISO 10555-6 - Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015 + Amd 1:2019) (includes Amendment A1:2019)
Published by DIN on February 1, 2020
A description is not available for this item.
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