PD ISO/TR 19057:2017

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Background including need for assessing the biodurability
   of particles
6 Aims and objectives
7 Approaches for assessment of micrometre mineral
   particle and fibre biodurability
8 Need for the assessment of nanomaterial biodurability
9 Influence of different types of ligands and coatings on
   nanomaterial biodurability
10 Review of methodologies to assess micrometre mineral
   particle and fibre biodurability
11 Calculation of micrometre mineral particle biodurability
12 Examples of micrometer mineral particles and fibres
   where biodurability was assessed using in vitro acellular
   systems
13 Examples of nanomaterials where biodurability was
   assessed using in vitro acellular systems
14 Biodurability of ligands
15 Relationship with relevant international documents
16 Assessing the validity of assay/test systems
17 Biological relevance of the dissolution assay
18 Use of biodurability tests in risk assessment and its
   limitations
Annex A (informative) - Tables of relevant information
Bibliography

Describes the use and application of acellular in vitro tests and methodologies implemented in the assessment of the biodurability of nanomaterials and their ligands in simulated biological and environmental media.

This document reviews the use and application of acellular in vitro tests and methodologies implemented in the assessment of the biodurability of nanomaterials and their ligands in simulated biological and environmental media.

This document is intended to focus more on acellular in vitro methodologies implemented to assess biodurability and, therefore, excludes the general review of relevant literature on in vitro cellular or animal biodurability tests.