Name: UNI EN ISO 10993-13 : 2010
Brand: UNI

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES

Published date

08-05-2010

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 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	UNI EN ISO 10993-13 : 2009

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
DIN EN ISO 10993-13 E : 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