NS EN ISO 10993-9 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
06-11-2021
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
Gives general principles of systematic evaluating of the potential and observed biodegradation of medical devices and for designing and performing biodegradation studies.
| DocumentType |
Standard
|
| PublisherName |
Norwegian Standards (Norges Standardiseringsforbund)
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ONORM EN ISO 10993-9 : 2010 | Identical |
| UNE-EN ISO 10993-9:2010 | Identical |
| I.S. EN ISO 10993-9:2009-12 | Identical |
| NBN EN ISO 10993-9 : 2010 | Identical |
| EN ISO 10993-9:2009 | Identical |
| UNI EN ISO 10993-9 : 2010 | Identical |
| ISO 10993-9:2009 | Identical |
| BS EN ISO 10993-9 : 2009-12 | Identical |
| DIN EN ISO 10993-9:2010-04 | Identical |
| SN EN ISO 10993-9 : 2010 | Identical |
| NF EN ISO 10993-9 : 2010 | Identical |
| NEN EN ISO 10993-9 : 2010 | Identical |
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