I.S. EN ISO 10993-13:2010
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES (ISO 10993-13:2010)
Hardcopy , PDF
English
01-01-2010
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU Directive
93/42/EEC on Medical devices
Annex ZB (informative) - Relationship between this European
Standard and the Essential Requirements of EU Directive
90/385/EEC on Active Implantable Medical Devices
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