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SN 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

Available format(s)

Hardcopy

Published date

01-09-2010

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

ISO 10993-13:2010 provides 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.

Committee
INB/NK 129
DevelopmentNote
Supersedes SN 119800. (06/2006)
DocumentType
Standard
Pages
0
PublisherName
Swiss Standards
Status
Current
Supersedes

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