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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

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Organization: DIN
Publication Date: 1 November 2017
Status: inactive
Page Count: 27
ICS Code (Syringes, needles and catheters): 11.040.25
scope:

Dieser Teil von ISO 10555 legt Anforderungen, Leistung und Fragen zur Anwendersicherheit fest, die sich auf subkutan implantierte Ports und Katheter für intravaskuläre Langzeitanwendungen bei sterilen Bedingungen und zur einmaligen Verwendung beziehen.

Dieser Teil von ISO 10555 legt keine Anforderungen, Leistung und Fragen zur Anwendersicherheit bezogen auf stanzfreie Kanülen fest.

ANMERKUNG Subkutan implantierte Ports werden bekanntermaßen für Anzeichen genutzt, die anders als intravaskulär sind, wie z. B. intraperitonealer, intrathekaler, intrapleuraler und epiduraler Zugang.

Document History

DIN EN ISO 10555-6
February 1, 2020
Intravaskulaere Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 6: Subkutan implantierte Ports (ISO 10555-6:2015 + Amd 1:2019); Deutsche Fassung EN ISO 10555-6:2017 + A1:2019
A description is not available for this item.
DIN EN ISO 10555-6/A1
June 1, 2019
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports - AMENDMENT 1 (ISO 10555-6:2015/DAM 1:2019); German and English version EN ISO 10555-6:2015/prA1:2019
A description is not available for this item.
DIN EN ISO 10555-6
November 1, 2017
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015); German version EN ISO 10555-6:2017
Dieser Teil von ISO 10555 legt Anforderungen, Leistung und Fragen zur Anwendersicherheit fest, die sich auf subkutan implantierte Ports und Katheter für intravaskuläre Langzeitanwendungen bei...
DIN EN ISO 10555-6
May 1, 2017
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015); German and English version FprEN ISO 10555-6:2017
A description is not available for this item.

References

This document references:
F2052 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
October 1, 2021
This test method covers the measurement of the magnetically induced displacement force produced by static magnetic field gradients (spatial field gradient) on medical devices and the comparison of...
This document references:
ASTM F2119 - Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
Published by ASTM on September 1, 2007
This test method characterizes the distortion and signal loss artifacts produced in a magnetic resonance (MR) image by a passive implant (implant that functions without the supply of electrical or...
This document references:
ASTM F2182 - Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
Published by ASTM on September 15, 2019
This test method covers measurement of radio frequency (RF)-induced heating on or near a passive medical implant within a phantom during magnetic resonance imaging (MRI). The test method does not...
This document references:
ASTM F2213 - Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
Published by ASTM on September 1, 2017
This test method covers the measurement of the magnetically induced torque produced by the static magnetic field in the magnetic resonance environment on medical devices and the comparison of that...
This document references:
DIN EN ISO 10555-1 - Intravaskulaere Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1: Allgemeine Anforderungen (ISO 10555-1:2013 + Amd 1:2017); Deutsche Fassung EN ISO 10555-1:2013 + A1:2017
Published by DIN on April 1, 2018
Dieser Teil der ISO 10555 legt allgemeine Anforderungen an intravaskuläre Katheter jedes Verwendungszwecks fest, die steril geliefert werden und zur einmaligen Verwendung bestimmt sind. Sie gilt...
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