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EN ISO 10993-15:2009

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)

Withdrawn date

21-03-2010

Published date

10-06-2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Degradation test methods
  4.1 General
  4.2 Prerequisites
5 Reagent and sample preparation
  5.1 Sample documentation
  5.2 Test solution (electrolyte)
  5.3 Preparation of test samples
6 Electrochemical tests
  6.1 Apparatus
  6.2 Sample preparation
  6.3 Test conditions
  6.4 Potentiodynamic measurements
  6.5 Potentiostatic measurements
7 Immersion test
  7.1 Apparatus
  7.2 Sample preparation
  7.3 Immersion test procedure
8 Analysis
9 Test report
Annex A (informative) - Schematic diagram of the
        electrochemical measuring circuit
Annex B (informative) - Schematic drawing of an
        electrolytic cell
Annex C (informative) - Examples of alternative
        electrolytes for the electrochemical tests
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of
         EU Directive 93/42/EEC on Medical Devices

Gives guidance 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
CEN/TC 206
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Withdrawn

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UNE-EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
BS EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches

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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