ÖNORM EN ISO 10993-14

Issue date: 2009 09 15

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

This part of ISO 10993 specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also gives guidance on the analysis of these solutions in order to identify the degradation products. Because of the generalized nature of this part of ISO 10993, product specific standards, when available, that address degradation product formation under more relevant conditions of use, should be considered first. This part of ISO 10993 considers only those degradation products generated by a chemical dissociation of ceramics during in vitro testing.

General information on ÖNORM EN ISO 10993-14

Format

Digital | 20 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 179 Medical technology

Timeline

An overview of the development of ÖNORM EN ISO 10993-14 from 2002 til today.

ÖNORM EN ISO 10993-14

2009 09 15 Norm

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation...
ÖNORM EN ISO 10993-14

2002 05 01 Norm

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation...

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer	Titel	Ausgabedatum	Art
Dokumentnummer ISO 10993-1:2018	Titel Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)	Ausgabedatum 2018 08 17	Art Norm	Zur Produktseite
Dokumentnummer ISO 10993-9:2019	Titel Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products	Ausgabedatum 2019 11 26	Art Norm	Zur Produktseite
Dokumentnummer ISO 3310-1:2016	Titel Test sieves — Technical requirements and testing — Part 1: Test sieves of metal wire cloth	Ausgabedatum 2016 07 21	Art Norm	Zur Produktseite
Dokumentnummer ISO 3696:1987	Titel Water for analytical laboratory use — Specification and test methods	Ausgabedatum 1987 04 09	Art Norm	Zur Produktseite
Dokumentnummer ISO 5017:2013	Titel Dense shaped refractory products — Determination of bulk density, apparent porosity and true porosity	Ausgabedatum 2013 01 08	Art Norm	Zur Produktseite
Dokumentnummer ISO 6474:1994	Titel Implants for surgery — Ceramic materials based on high purity alumina	Ausgabedatum 1994 02 03	Art Norm	Zur Produktseite
Dokumentnummer ISO 6872:1995	Titel Dental ceramic	Ausgabedatum 1995 08 24	Art Norm	Zur Produktseite

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Norm

ÖNORM EN ISO 10993-14 - Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

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