ISO 4962:2024 PDF

Name: ISO 4962:2024 — Nanotechnologies — In vitro acute nanoparticle phototoxicity assay
SKU: ISO 4962:2024
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Nanotechnologies — In vitro acute nanoparticle phototoxicity assay

Название (английский):

ISO 4962:2024

Nanotechnologies — In vitro acute nanoparticle phototoxicity assay

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 22
Дата публикации:: 5 ноября 2024 г.
Издание:: ISO IS 4962 edition 1 version 1
ICS:: 07.120

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Описание (английский):

This document specifies a procedure to evaluate acute phototoxicity of nanoparticles (NPs), suspended in cell culture media, by measuring the relative reduction in cellular viability under near ultraviolet (UVA) exposure (315 nm to 400 nm). The measurement is intended to assess the potential for acute phototoxicity of NPs by comparing NP photoactivity in vitro to a positive control chlorpromazine. It is not designed to predict other joint effects of nanomaterials and light, such as genotoxicity, photo-allergy or photo-mutagenicity. The method is also applicable to NP aggregates and agglomerates.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 4962:2024 is an international standard from ISO focused on nanotechnologies, specifically providing a validated in vitro procedure for assessing acute nanoparticle phototoxicity. The standard outlines a method to evaluate the potential phototoxic effects of nanoparticles (NPs) suspended in cell culture media by measuring the reduction in cellular viability after exposure to near ultraviolet A (UVA) light (315 nm to 400 nm). By comparing the in vitro photoactivity of nanoparticles to a known positive control (chlorpromazine), this standard helps determine the acute phototoxicity of various nanomaterials, including nanoparticle aggregates and agglomerates. The standard is not intended for predicting other light-material interaction effects like genotoxicity, photo-allergy, or photo-mutagenicity.

Key Topics

Phototoxicity Evaluation: The core of ISO 4962:2024 is the procedure to measure acute phototoxicity of nanoparticles. Phototoxicity refers to toxic responses triggered or intensified upon exposure to light, particularly UVA, due to activation of photoreactive substances.

Test Methodology: The standard specifies using a 96-well plate format, incorporating a controlled UVA light source, and optical plate readers for rapid and reproducible results. Cell viability is determined after NP/UVA exposure by standard colorimetric assays.

Controls and Comparisons: Simultaneous use of positive (chlorpromazine) and negative (cell media) controls is required to benchmark any phototoxic effects observed.

Sample Preparation and Validation: Detailed steps on how to prepare, dose, and characterize nanoparticle suspensions are provided, with special attention to avoiding endotoxin contamination and verifying NP dispersion and stability in the test medium.

Assay Interference: The standard addresses potential artefacts and interference from nanoparticles with the cell viability assay, ensuring that measured cell toxicity is truly due to phototoxic mechanisms.

Applications

ISO 4962:2024 is a valuable tool for researchers, regulatory agencies, material scientists, and industries engaged in the development and safety assessment of nanoparticles. Typical applications include:

Safety Testing of Nanomaterials: Evaluate potential acute phototoxic risks during the development of nanotechnology-enabled products such as cosmetics, sunscreens, topical medications, advanced coatings, and medical devices.

Product Development: Guide manufacturers in screening the phototoxic behavior of nanoparticle formulations early in the design process to ensure consumer and environmental safety.

Regulatory Submissions: Provide evidence of compliance with international best practices for nanomaterial safety, increasingly required for regulatory approvals in biotechnology, healthcare, and consumer goods.

Comparative Material Studies: Enable consistent comparison of phototoxic potential between different NP types (e.g., TiO₂, ZnO, quantum dots, metal nanoparticles) or between nano-formulated and traditional products.

Academic Research: Facilitate fundamental research into biological effects of nanomaterials, supporting reproducibility and cross-laboratory consistency in toxicity testing.

Related Standards

To ensure comprehensive evaluation and reporting in nanoparticle toxicity and characterization, the following related standards are often referenced alongside ISO 4962:2024:

ISO 80004-1:2023 - Nanotechnologies - Vocabulary - Part 1: Core vocabulary (provides definitions for key nanotechnology terms)

ISO 22412 - Particle size analysis - Dynamic light scattering (DLS) (used for verifying NP dispersion)

ISO 29701 - Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems (addresses endotoxin contamination detection)

ISO 19007 - Nanotechnologies - In vitro MTS assay for measuring cell viability (referenced for cell viability assessment procedure)

OECD 432 - In vitro 3T3 NRU phototoxicity test (relevant for soluble chemicals; background for method differentiation)

By following ISO 4962:2024, stakeholders can apply a harmonized, robust approach to nanoparticle phototoxicity screening, supporting safe innovation in nanotechnology and alignment with international regulatory expectations.

ISO 4962:2024 PDF

Abstract

Похожие стандарты

Overview

Key Topics

Applications

Related Standards

Технические детали

ISO 80004-1:2023

Nanotechnologies – Vocabulary — Part 1: Core vocabulary

ISO 22412:2008

Particle size analysis — Dynamic light scattering (DLS)

SIST EN ISO 29701:2011

Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LA…

ISO 19007:2018

Nanotechnologies — In vitro MTS assay for measuring the cytotoxic effect of nanoparticles