BS EN ISO 10993-9 : 2009-12
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
Hardcopy , PDF
English
01-12-2009
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for design of degradation studies
5 Study report
Annex A (normative) - Consideration of the need for
degradation studies
Annex B (informative) - Biodegradation study considerations
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
Bibliography
Gives general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies.
| Committee |
CH/194
|
| DevelopmentNote |
Supersedes 97/564056 DC. (05/2005)
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
| 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 |
| NS EN ISO 10993-9 : 2009 | 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 |
| 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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