NBN EN ISO 10993-18 : 2009
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
12-01-2013
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 Step 1 - Qualitative information
6.3 Step 2 - Material equivalence
6.4 Step 3 - Quantitative information
6.5 Step 4 - Quantitative risk assessment
6.6 Step 5 - Estimated clinical exposure to chemicals present
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 (normative) Flowchart summarizing the stepwise
generation of chemical characterization data for
use in toxicological risk assessment
Annex B (informative) Information sources for chemical
characterization
Annex C (informative) Principles for judging toxicological
equivalency
Bibliography
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42 EEC
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