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DIN
DIN EN ISO 10993-13 E : 2010

DIN EN ISO 10993-13 E : 2010

Current

Current

The latest, up-to-date edition.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2010

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Degradation test methods
5 Test procedures
6 Test report
Annex A (informative) - Analytical methods
Annex B (informative) - Environmental stress cracking (ESC)
         of polymers
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC on Medical Devices
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 90/385/EEC on Active Implantable Medical
         Devices
National Annex NA (informative) - Bibliography
Bibliography

Explains two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment.

DocumentType
Standard
Pages
24
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

DIN EN ISO 10993-10 E : 2003 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)
DIN EN ISO 10993-15 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
DIN EN ISO 10993-10:2003-02 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)

ISO 13781:2017 Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing
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
DIN EN ISO 10993-12 E : 2012 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012)
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
DIN EN ISO 10993-17 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES
ISO 14971:2007 Medical devices Application of risk management to medical devices
DIN ISO 3696:1991-06 WATER FOR ANALYTICAL LABORATORY USE - SPECIFICATION AND TEST METHODS

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PDF - English
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