UNI EN ISO 10993-15 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
08-03-2023
09-17-2009
PREMESSA
INTRODUZIONE
1 SCOPO E CAMPO DI APPLICAZIONE
2 RIFERIMENTI NORMATIVI
3 TERMINI E DEFINIZIONI
4 METODI DI PROVA DELLA DEGRADAZIONE
5 REAGENTE E PREPARAZIONE DEL CAMPIONE
6 PROVE ELETTROCHIMICHE
7 PROVA DI IMMERSIONE
8 ANALISI
9 RESOCONTO DI PROVA
APPENDICE A (informativa) - DIAGRAMMA SCHEMATICO DEL CIRCUITO
DI MISURAZIONE ELETTROCHIMICA
APPENDICE B (informativa) - RAPPRESENTAZIONE SCHEMATICA DI UNA
CELLA ELETTROLITICA
APPENDICE C (informativa) - ESEMPI DI ELETTROLITI ALTERNATIVI
PER LE PROVE ELETTROCHIMICHE
APPENDICE ZA (informativa) - RAPPORTO FRA LA PRESENTE NORMA
EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA
UE 93/42/CEE
BIBLIOGRAFIA
Offers guidelines on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use.
| Committee |
CT 44
|
| DevelopmentNote |
Bilingual (Italian + English) version issued in OCTOBER 2011. (10/2011)
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 10993-15 : 2009 | Identical |
| DIN EN ISO 10993-15:2009-10 | Identical |
| SN EN ISO 10993-15 : 2009 | Identical |
| NF EN ISO 10993-15 : 2009 | Identical |
| EN ISO 10993-15:2009 | Identical |
| ISO 10993-15:2000 | Identical |
| BS EN ISO 10993-15:2009 | Identical |
| NS EN ISO 10993-15 : 2009 | Identical |
| I.S. EN ISO 10993-15:2009 | Identical |
| UNE-EN ISO 10993-15:2009 | Identical |
| NBN EN ISO 10993-15 : 2009 | Identical |
| NEN EN ISO 10993-15 : 2009 | Identical |
| ISO 10993-16:2017 | Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
| NFS 91 141 : 1997 | BIODEGRADABILITY OF DENTAL METAL ALLOYS - STANDARDIZATION OF ELECTROCHEMICAL TESTS |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ISO 3585:1998 | Borosilicate glass 3.3 — Properties |
| ISO 10271:2011 | Dentistry Corrosion test methods for metallic materials |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 8044:2015 | Corrosion of metals and alloys Basic terms and definitions |
| 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 |
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