AAMI ISO 10993-15 : 2000 : R2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
Hardcopy , PDF
14-02-2023
English
01-01-2011
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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
|
| ISBN |
1-57020-155-2
|
| Pages |
22
|
| ProductNote |
Reconfirmed 2011
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 10993-15:2019 | 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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