ISO/TS 16195:2018 ナノテクノロジー—乾燥粉末形態のナノオブジェクトからなる代表的な試験材料を開発するための仕様 | ページ 2

Foreword

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This document was prepared by Technical Committee ISO/TC 229, Nanotechnologies.

This second edition cancels and replaces the first edition (ISO/TS 16195:2013), which has been technically revised.

Introduction

As new manufactured nano-objects are developed and find a wider range of industrial applications, the roles of physico-chemical, performance, and safety testing of their powders (i.e. dry, unsuspended accumulations of such objects) have become more important than ever. However, many testing methods are still under development and have to be properly evaluated in terms of their reliability. Where possible, validation of new measurement methods is performed using certified reference materials, which have known and quantified properties. In the absence of certified reference materials, one often has to rely on non-certified reference materials, with assigned but not certified property values. However, in developing fields of measurement and testing, such as that of nanotechnology, even non-certified reference materials are scarce. In such cases, “test materials,” which are evaluated for homogeneity and stability of one or several of their properties, will be helpful in efforts to improve the reproducibility of testing methods across testing laboratories and the comparability of test results across different test methods. This document specifies that for dry powders of nano-objects the following minimum information be gathered and provided in a verification report to qualify the material as a nanoscale representative test material:

• information describing the manufacturing process,
• information on the quality management of its manufacturing process,
• data from physico-chemical measurements representing the principal features of the representative test material, and
• data on the stability and homogeneity of the above parameters.

Conformity to this document, expressed in the form of a verification report, will provide a level of assurance that the representative test material is homogeneous, statistically representative of the manufacturing process, and has stability. This will increase the likelihood that measurements that are undertaken on the representative test material, whether for safety or function, are comparable across testing laboratories, even for properties for which methods are being developed and for which homogeneity and stability have not been quantitatively assessed.

1 Scope

This document specifies development of representative test materials consisting of nano-objects in dry powder form, to enable test method development and improve comparability of data for nanotechnology applications. It includes the physico-chemical properties (specifically, size and shape, specific surface area, crystal structure, and bulk chemical composition) that are required to be measured and reported with the representative test material.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO/TS 80004-1 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

Bibliography