UNI 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
26-08-2022
01-01-2010
PREMESSA
INTRODUZIONE
1 SCOPO E CAMPO DI APPLICAZIONE
2 RIFERIMENTI NORMATIVI
3 TERMINI E DEFINIZIONI
4 PRINCIPI PER LA PROGETTAZIONE DEGLI STUDI DI DEGRADAZIONE
5 RESOCONTO DELLO STUDIO
APPENDICE A (normativa) - CONSIDERAZIONI IN MERITO ALLA
NECESSITA DI CONDURRE DEGLI STUDI DI DEGRADAZIONE
APPENDICE B (informativa) - CONSIDERAZIONI IN MERITO ALLO
STUDIO DI BIODEGRADAZIONE
APPENDICE ZA (informativa) - RAPPORTO TRA LA PRESENTE NORMA
EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA UE
93/42/CEE CONCERNENTE I DISPOSITIVI MEDICI
APPENDICE ZB (informativa) - RAPPORTO TRA LA PRESENTE NORMA
INTERNAZIONALE E I REQUISITI ESSENZIALI DELLA DIRETTIVA UE
90/385/CEE RELATIVA AI DISPOSITIVI MEDICI IMPIANTABILI ATTIVI
BIBLIOGRAFIA
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.
| DocumentType |
Standard
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| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
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| Status |
Superseded
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| SupersededBy | |
| 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 |
| 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 |
| 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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