Name: UNI EN ISO 10993-15 : 2009
Brand: UNI

UNI EN ISO 10993-15 : 2009

Superseded

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS

Superseded date

03-08-2023

Published date

17-09-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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Status	Superseded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	UNI EN ISO 10993-15:2023
Supersedes	UNI EN ISO 10993-15 : 2002

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
DIN EN ISO 10993-15 E : 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