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NEN 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

01-12-2013

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 general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.

DocumentType
Standard
PublisherName
Netherlands Standards
Status
Current

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