UNE-EN ISO 10993-9:2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 (ISO 10993-9:2009)
Hardcopy , PDF
25-05-2022
Spanish, Castilian, English
09-06-2010
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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 |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
Asociacion Espanola de Normalizacion
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 10993-9 : 2010 | Identical |
| ISO 10993-9:2009 | Identical |
| NBN EN ISO 10993-9 : 2010 | Identical |
| NEN EN ISO 10993-9 : 2010 | Identical |
| NS EN ISO 10993-9 : 2009 | Identical |
| I.S. EN ISO 10993-9:2009-12 | Identical |
| SN EN ISO 10993-9 : 2010 | Identical |
| UNI EN ISO 10993-9 : 2010 | Identical |
| BS EN ISO 10993-9 : 2009-12 | Identical |
| EN ISO 10993-9:2009 | Identical |
| NF EN ISO 10993-9 : 2010 | Identical |
| DIN EN ISO 10993-9:2010-04 | Identical |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ISO 10271:2011 | Dentistry Corrosion test methods for metallic materials |
| 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 13781:2017 | Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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