ISO/TR 21624:2020 PDF

Name: ISO/TR 21624:2020 — Nanotechnologies — Considerations for in vitro studies of airborne nano‐objects and their aggregates and agglomerates (NOAA)
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Nanotechnologies — Considerations for in vitro studies of airborne nano‐objects and their aggregates and agglomerates (NOAA)

Название (английский):

ISO/TR 21624:2020

Nanotechnologies — Considerations for in vitro studies of airborne nano‐objects and their aggregates and agglomerates (NOAA)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 28
Дата публикации:: 28 апреля 2020 г.
Издание:: ISO TR 21624 edition 1 version 1
ICS:: 07.120

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Описание (английский):

This document collates information regarding the systems available for exposure and assessment of nano-objects and their aggregates and agglomerates (NOAA) for in vitro air exposure studies. It provides an overview of the various exposure systems and in vitro cell systems used to perform in vitro studies that simulate an inhalation toxicology study design.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO/TR 21624:2020 - Nanotechnologies: Considerations for in vitro studies of airborne nano‑objects and their aggregates and agglomerates (NOAA) collates current knowledge on systems and biological models used to assess inhalation-relevant exposures of airborne nano‑objects in vitro. The technical report focuses on exposure and assessment systems that simulate inhalation toxicology study design, comparing air‑liquid interface (ALI) and submerged approaches, and summarizing considerations for particle generation, characterization, dosing and choice of cell systems.

Key topics and technical considerations

Modes of exposure

Direct exposure (aerosol delivered to cells under submerged, intermittently submerged or ALI conditions) and indirect exposure (collection of aerosols and subsequent suspension).
ALI systems are preferred for inhalation-relevant testing because they better reproduce airway cell phenotype and particle deposition.

Characterization of NOAA

Importance of monitoring particle size, aggregation/agglomeration state, life‑cycle transformations and how aerosol generation can alter particle properties.

Choice of cell systems

Guidance on mono‑culture, co‑culture and three‑dimensional models that reflect epithelial differentiation, mucus production and barrier functions.

Dose selection and metrics

Considerations for relevant concentrations, deposited dose assessment and use of in silico tools for dosimetry (e.g., to relate administered dose to deposition).

Practical limitations

Effects of suspending media on agglomeration, sedimentation and dissolution under submerged conditions; potential for misleading toxicity outcomes if in vitro conditions diverge from inhalation realities.

Adverse Outcome Pathways (AOPs)

Annex A discusses applying AOPs to design mechanistic, in vitro‑based approaches.

Practical applications

ISO/TR 21624:2020 provides a structured, pragmatic reference for:

Designing inhalation‑relevant in vitro studies of nanoparticles and NOAA

Selecting exposure chambers and ALI platforms for nanosafety testing

Choosing biologically relevant cell models (mono‑ and co‑cultures, 3D) and dose metrics

Interpreting differences between submerged and ALI exposures for regulatory or risk assessment contexts

Who should use this standard

Nanotoxicology researchers and academic laboratories

Industrial R&D and nanosafety teams developing inhalation exposure testing

Respiratory toxicologists and in vitro assay developers

Regulatory scientists and risk assessors seeking harmonized approaches for in vitro inhalation studies

Instrument and exposure system manufacturers

Related standards

ISO/TR 19601 (overview of aerosol generation and in vivo testing) - referenced in the report

ISO 15900 and ISO/TS 80004 series - referenced for terminology and definitions

This technical report is a guidance/overview document (not a prescriptive protocol) aimed at harmonizing approaches for in vitro assessment of airborne nano‑objects and improving the physiological relevance of inhalation toxicity testing. Keywords: ISO/TR 21624:2020, NOAA, nanotechnologies, in vitro inhalation, air‑liquid interface, aerosol exposure, nanoparticle dosimetry, nanosafety.

ISO/TR 21624:2020 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical considerations

Practical applications

Who should use this standard

Related standards

Технические детали

PD ISO/TR 19601:2017

Nanotechnologies. Aerosol generation for air exposure studies of nano-objects and their aggregates and agglom…

BS ISO 15900:2009

Determination of particle size distribution. Differential electrical mobility analysis for aerosol particles

SIST-TS CEN ISO/TS 80004-13:2024

Nanotechnologies - Vocabulary - Part 13: Graphene and other two-dimensional (2D) materials (ISO/TS 80004-13:2…