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AAMI ISO 10993-15 : 2000

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
Available format(s)

Hardcopy , PDF

Superseded date

09-01-2021

Language(s)

English

Published date

01-01-2011

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 10993-15:2000
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
      5.3.1 Test samples
      5.3.2 Sampling
      5.3.3 Sample shape
      5.3.4 Sample surface condition
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
Annexes
A - Schematic diagram of the electrochemical measuring
    circuit
B - Schematic drawing of an electrolytic cell
C - Electrolytes for the electrochemical tests
Bibliography

Provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding materials samples finished as ready for clinical use.

Committee
WG 02
DocumentType
Standard
Pages
22
ProductNote
Reconfirmed 2000
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

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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