Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

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English, German

Published date

01-11-2010

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DocumentType	Standard
Pages	24
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current
Supersedes	DIN EN ISO 10993-13:2009-08

DIN EN ISO 10993-1:2010-04	Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009)
DIN EN ISO 10993-10:2014-10	Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
DIN EN ISO 10993-15:2009-10	Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
DIN EN ISO 10993-9:2010-04	Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

DIN EN ISO 14971:2013-04	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
ISO 13781:2017	Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing
DIN EN ISO 10993-12:2012-10	Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
ISO 10993-12:2012	Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
ISO 10993-17:2002	Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009	Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 10993-9:2009	Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
ISO 3696:1987	Water for analytical laboratory use — Specification and test methods
ISO 14971:2007	Medical devices — Application of risk management to medical devices
DIN EN ISO 10993-17:2009-08	Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
DIN ISO 3696:1991-06	WATER FOR ANALYTICAL LABORATORY USE - SPECIFICATION AND TEST METHODS
DIN EN ISO 10993-9:2010-04	Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

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DIN EN ISO 10993-13:2010-11