GB/T 39261-2020Nanotechnologies. Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard uses the translation method equivalent to ISO /T R13014.2012 "Nanotechnology and Nanomaterials Physical and Chemical Properties before Toxicology Evaluation" Enlistment Guide. This standard has made the following editorial changes.

---Reorder the references.

Introduction

In recent years, with the widespread application of nanomaterials in consumer goods and other products, people have increasingly paid attention to exposure to nanomaterials (especially It is the health and environmental problems that may be caused by nano-objects and their aggregates and aggregates (NOAA)]. Although there has been a lot of information about NOAA However, most of these studies did not provide detailed physical and chemical characterization data, or did not evaluate and compare the test results obtained. fruit. Given that different NOAAs have similar compositions, specific physical and chemical characterization is the key to determining the material under study, and is conducive to further Step to understand the toxicity of nanomaterials.

This guide provides guidance for the physical and chemical characterization of commercial man-made nano-objects before toxicity assessment (including population and ecological assessment). The purpose is to cooperate To help scientists in other fields understand, plan, identify and confirm the physical and chemical properties of these materials before conducting toxicological research.

The premise of academic evaluation is consistent with other ISO standards. For example, ISO 10993-18 provides chemical tables for materials used in medical equipment.

According to ISO 14971, toxicological risk analysis needs to consider the chemical properties of materials.

Characterization of physical and chemical properties can provide important information for a better understanding of the relationship between toxicological test results and physical and chemical properties. This guide The following valuable physical and chemical characterization information is provided to facilitate subsequent toxicological evaluation.

---How does the physical and chemical characterization fit in with NOAA's toxicology testing process;

---Physical and chemical characterization is the key to toxicology testing;

---What parameters are included in the physical and chemical characterization.

1 Scope

This standard provides guidance on the characterization of physical and chemical properties of man-made nano-objects and aggregates and agglomerates (NOAA) larger than 100 nm.

The purpose is to provide assistance in evaluating and clarifying the influence of physical and chemical properties on toxicological effects, and it can also be used to distinguish the material to be tested from its similar materials. This standard provides descriptions, instructions, correlations, examples of methods to be measured and test methods for each physical and chemical property.

This standard is intended for researchers who are committed to studying the potential toxicological effects of NOAA (such as toxicologists, ecotoxicologists, management personnel, Health and safety experts) have reference value.

2 Terms and definitions

ISO/TS 27687, ISO/TS 80004-1, ISO/TS 80004-3, ISO/IEC Guide 99 and the following terms and definitions apply to this document.