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DIN EN ISO 10993-10

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2013

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Organization: DIN
Publication Date: 1 October 2014
Status: active
Page Count: 83
ICS Code (Biological evaluation of medical devices): 11.100.20
scope:

Dieser Teil der ISO 10993 beschreibt das Verfahren für die Beurteilung von Medizinprodukten und ihren Bestandteilen hinsichtlich ihres Potentials, eine Irritation und eine Hautsensibilisierung hervorzurufen.

Dieser Teil der ISO 10993 enthält:

a) vor der Prüfung durchzuführende Überlegungen hinsichtlich einer Irritation, einschließlich In-silico- und Invitro- Verfahren zur dermalen Exposition;

b) Einzelheiten zur Durchführung von In-vivo-Prüfungen (Irritation und Sensibilisierung);

c) Schlüsselfaktoren für die Interpretation der Ergebnisse.

Anhang A enthält Anweisungen für die spezielle Vorbereitung von Materialien im Zusammenhang mit den vorstehend angeführten Prüfungen. In Anhang B sind mehrere spezielle Prüfungen auf Irritation bei der Anwendung von Medizinprodukten in anderen Bereichen als der Haut beschrieben.

Document History

April 1, 2020
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO/DIS 10993-10:2020); German and English version prEN ISO 10993-10:2020
A description is not available for this item.
DIN EN ISO 10993-10
October 1, 2014
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2013
Dieser Teil der ISO 10993 beschreibt das Verfahren für die Beurteilung von Medizinprodukten und ihren Bestandteilen hinsichtlich ihres Potentials, eine Irritation und eine Hautsensibilisierung...
December 1, 2010
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2010
A description is not available for this item.
August 1, 2009
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006); German version EN ISO 10993-10:2009
A description is not available for this item.
February 1, 2009
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006); English version prEN ISO 10993-10:2008, Amendment 2
A description is not available for this item.
August 1, 2008
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO/DIS 10993-10:2008); German version prEN ISO 10993-10:2008
A description is not available for this item.
June 1, 2007
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002+Amd.1:2006); German version EN ISO 10993-10:2002+A1:2006
A description is not available for this item.
March 1, 2005
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002/DAM1:2004); German version EN ISO 10993-10:2003/prA1:2004
A description is not available for this item.
February 1, 2003
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002); German version EN ISO 10993-10:2002
A description is not available for this item.
February 1, 1996
Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization (ISO 10993-10:1995); German version EN ISO 10993-10:1995
A description is not available for this item.

References

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