ONORM EN ISO 10993-9 : 2010
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
02-15-2022
01-12-2013
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.
| Committee |
TC 179
|
| DocumentType |
Standard
|
| PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| 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 |
| NS EN ISO 10993-9 : 2009 | Identical |
| BS EN ISO 10993-9 : 2009-12 | Identical |
| NEN EN ISO 10993-9 : 2010 | Identical |
| DIN EN ISO 10993-9:2010-04 | Identical |
| SN EN ISO 10993-9 : 2010 | Identical |
| NF EN ISO 10993-9 : 2010 | Identical |
| OVE/ONORM EN 60601-1 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012) |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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