ANSI/AAMI BE83:2006(R2011)
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
English
02-12-2011
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 10993-18:2005 and
rationale for major technical deviations
Major technical deviations from ISO 10993-18:2005
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General principles
6 Characterization procedure
6.1 General
6.2 Qualitative information
6.3 Quantitative information
7 Chemical characterization parameters and methods
7.1 General
7.2 Polymers
7.3 Metals and alloys
7.4 Ceramics
7.5 Natural macromolecules
8 Reporting of data obtained
Annex A (informative) - Information sources for chemical
characterization
Bibliography
Defines a framework for the identification of a material and the identification and quantification of its chemical constituents.
| Committee |
ISO/TC 194
|
| DocumentType |
Standard
|
| ISBN |
1-57020-257-5
|
| Pages |
31
|
| ProductNote |
Reconfirmed 2011
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 10993-18:2005 | Identical |
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