Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General principles
6 Characterisation 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 characterisation 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 summarising the stepwise
generation of chemical characterisation data
for use in toxicological risk assessment
A.1 General
A.2 Procedure
Annex B (informative) Information sources for chemical characterisation
B.1 General
B.2 Generic name of material
B.3 Other nomenclature and structure formulae of polymeric
chemicals
B.3.1 General
B.3.2 IUPAC nomenclature and structure formulae of
polymeric chemicals
B.3.3 CAS registry number, USAN, and other registry name
and/or number
B.4 General information concerning chemical nature of materials
B.5 Information from the material supplier
B.6 Chemical analysis
B.6.1 Non-specific chemical analysis relevant to exposure
assessment
B.6.2 Qualitative analysis
B.6.3 Quantitative analysis of specific toxic chemicals
for exposure assessment
B.7 National and international material and/or product standards
B.8 Material master file
Annex C (informative) Principles for judging toxicological equivalency
Bibliography