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DIN EN ISO 14155-2

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); German version EN ISO 14155-2:2009

inactive, Most Current
Organization: DIN
Publication Date: 1 November 2009
Status: inactive
Page Count: 17
ICS Code (Biological evaluation of medical devices): 11.100.20

Document History

DIN EN ISO 14155-2
November 1, 2009
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); German version EN ISO 14155-2:2009
A description is not available for this item.
DIN EN ISO 14155-2/A1
April 1, 2009
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); English version FprEN ISO 14155-2:2009, Amendment 1
A description is not available for this item.
DIN EN ISO 14155-2
September 1, 2003
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); German version EN ISO 14155-2:2003
A description is not available for this item.
DIN EN ISO 14155-2
August 1, 2001
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO/DIS 14155-2:2001); German version prEN ISO 14155-2:2001
A description is not available for this item.

References

This document is referenced by:
DIN EN ISO 10993-10 - Biologische Beurteilung von Medizinprodukten - Teil 10: Pruefungen auf Irritation und Hautsensibilisierung (ISO 10993-10:2010); Deutsche Fassung EN ISO 10993-10:2013
Published by DIN on October 1, 2014
Dieser Teil der ISO 10993 beschreibt das Verfahren für die Beurteilung von Medizinprodukten und ihren Bestandteilen hinsichtlich ihres Potentials, eine Irritation und eine Hautsensibilisierung...
This document is referenced by:
DIN EN ISO 10993-10 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
Published by DIN on October 1, 2014
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This...
This document is referenced by:
DIN EN ISO 11979-10 - Ophthalmische Implantate - Intraokularlinsen - Teil 10: Klinische Pruefungen von Intraokularlinsen zur Korrektion der Ametropie in phaken Augen (ISO 11979-10:2018); Deutsche Fassung EN ISO 11979-10:2018
Published by DIN on August 1, 2018
Dieses Dokument legt Anforderungen für Intraokularlinsen fest, die zur Implantation in den Vorderabschnitt des Auges vorgesehen sind mit der primären Indikation, dessen Brechkraft zu modifizieren. Es...
This document is referenced by:
DIN EN ISO 11979-7 - Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Pruefungen von Intraokularlinsen fuer die Korrektion von Aphakie (ISO 11979-7:2018); Deutsche Fassung EN ISO 11979-7:2018
Published by DIN on August 1, 2018
Dieses Dokument legt die besonderen Anforderungen an die klinische Prüfung von Intraokularlinsen (IOL) fest, die zur Korrektur von Aphakie in das Auge implantiert werden.
This document is referenced by:
DIN EN ISO 25539-2 - Kardiovaskulaere Implantate - Endovaskulaere Implantate - Teil 2: Gefaessstents (ISO 25539-2:2020); Deutsche Fassung EN ISO 25539-2:2020
Published by DIN on January 1, 2021
A description is not available for this item.
This document is referenced by:
DIN EN ISO 25539-2 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)
Published by DIN on January 1, 2021
A description is not available for this item.
This document is referenced by:
DIN EN ISO 80601-2-56 - Medizinische elektrische Geraete - Teil 2-56: Besondere Festlegungen fuer die Sicherheit einschliesslich der wesentlichen Leistungsmerkmale von medizinischen Thermometern zum Messen der Koerpertemperatur (ISO 80601-2-56:2017 + Amd1:2018); Deutsche Fassung EN ISO 80601-2-56:2017 + A1:2020
Published by DIN on August 1, 2020
A description is not available for this item.
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