UNI EN ISO 10993-13 : 2010
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
05-08-2010
PREMESSA
INTRODUZIONE
1 SCOPO E CAMPO DI APPLICAZIONE
2 RIFERIMENTI NORMATIVI
3 TERMINI E DEFINIZIONI
4 METODI DI PROVA DELLA DEGRADAZIONE
5 PROCEDIMENTI DI PROVA
6 RAPPORTO DI PROVA
APPENDICE A (informativa) - METODI ANALITICI
APPENDICE B (informativa) - FESSURAZIONE SOTTO SFORZO PER
EFFETTO AMBIENTALE (ESC) DEI POLIMERI
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 FRA LA PRESENTE NORMA
EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA
UE 90/385/CEE SUI DISPOSITIVI MEDICI IMPIANTABILI
ATTIVI
BIBLIOGRAFIA
Describes general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. Also provides two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 10993-13:2010-11 | Identical |
| NBN EN ISO 10993-13 : 2010 | Identical |
| NS EN ISO 10993-13 : 2010 | Identical |
| UNE-EN ISO 10993-13:2010 | Identical |
| I.S. EN ISO 10993-13:2010 | Identical |
| BS EN ISO 10993-13:2010 | Identical |
| SN EN ISO 10993-13:2010 | Identical |
| NF EN ISO 10993-13 : 2010 | Identical |
| ISO 10993-13:2010 | Identical |
| NEN EN ISO 10993-13 : 2010 | Identical |
| EN ISO 10993-13:2010 | Identical |
| ISO 13781:2017 | Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10993-9:2009 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
| ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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