NEN EN ISO 10993-9 : 2010
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
12-01-2013
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for design of degradation studies
4.1 General
4.2 Preliminary considerations
4.3 Study design
4.4 Characterization of degradation products from
medical devices
5 Study report
Annex A (normative) Considerations of the need for
degradation studies
Annex B (informative) Biodegradation study considerations
Annex ZA (normative) Normative references to international
publications with their relevant
European publications
Bibliography
Defines general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies.
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Current
|
| Standards | Relationship |
| UNE-EN ISO 10993-9:2010 | Identical |
| UNI EN ISO 10993-9 : 2010 | Identical |
| NS EN ISO 10993-9 : 2009 | Identical |
| EN ISO 10993-9:2009 | Identical |
| SN EN ISO 10993-9 : 2010 | Identical |
| ONORM EN ISO 10993-9 : 2010 | Identical |
| ISO 10993-9:2009 | Identical |
| BS EN ISO 10993-9 : 2009-12 | Identical |
| I.S. EN ISO 10993-9:2009-12 | Identical |
| DIN EN ISO 10993-9:2010-04 | Identical |
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