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ONORM EN ISO 10993-10 : 2014

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)

Superseded date

28-07-2023

Published date

12-01-2013

Dieser Teil der Norm beschreibt Verfahren für die Beurteilung von Medizinprodukten und ihrer Bestandteile hinsichtlich des Hervorrufens einer Irritation und einer Allergie vom verzögerten Typ. Es sind enthalten: a) vor der Prüfung durchzuführende Überlegungen; b) die Durchführung der Prüfung; c) Schlüsselfaktoren bei der Auslegung der Ergebnisse.

Committee
TC 179
DocumentType
Standard
PublisherName
Osterreichisches Normungsinstitut/Austrian Standards
Status
Superseded
SupersededBy

ONORM EN 14683 : 2014 MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
OVE/ONORM EN 60601-1 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012)
ONORM EN 455-3 : 2015 MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION

ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-14:2001 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products

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