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NS EN ISO 10993-13 : 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

Published date

12-01-2013

1 Scope
2 Normative references
3 Definitions
4 Degradation test methods
    4.1 General procedures
    4.2 Accelerated degradation test
    4.3 Real-time degradation test
5 Test procedures
    5.1 Initial material characterization
    5.2 Accelerated degradation test
    5.3 Real-time degradation test
6 Test report
Annex A Analytical methods

Gives guidance on general requirements for designing of tests for identification and quantifying degradation products from finished polymeric medical devices ready for clinical use.

DocumentType
Standard
PublisherName
Norwegian Standards (Norges Standardiseringsforbund)
Status
Current

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