ISO/TS 11353:2026 PDF

Name: ISO/TS 11353:2026 — Nanotechnologies — A test method for detection of nano-object(s) release from mask media
SKU: ISO/TS 11353:2026
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Nanotechnologies — A test method for detection of nano-object(s) release from mask media

Название (английский):

ISO/TS 11353:2026

Nanotechnologies — A test method for detection of nano-object(s) release from mask media

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 21
Дата публикации:: 13 января 2026 г.
Издание:: ISO TS 11353 edition 1 version 1
ICS:: 07.120

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Описание (английский):

This document specifies a test method for the detection of nano-objects release, irrespective of its causes, from surgical masks, surgical respirator masks and barrier face coverings [reusable (regardless of washing characteristics) and disposable types] containing nano-objects, irrespective of the type of production technology. In addition, this document also provides the sampling procedures and qualitative characterization methods for released nano-objects. This document can be used to show the possible exposure due to release, which relates to human health and safety.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO/TS 11353:2026 specifies a standardized test method for detecting the release of nano-objects from mask media. This technical specification applies to surgical masks, surgical respirator masks, and barrier face coverings-both reusable and disposable-containing nano-objects, regardless of the production technology. The standard also provides detailed procedures for sampling and qualitative characterization of released nano-objects. Its main objective is to support the assessment of potential exposure risks to humans arising from the release of nano-objects, thereby contributing to human health and safety.

With the increasing integration of nanotechnologies into filter media for enhanced performance, understanding and controlling the possible release of nano-objects during mask use is essential. This standard aims to fill the gap in international guidelines for evaluating exposure due to nano-object release, supporting regulatory, manufacturing, and market requirements.

Key Topics

Scope of Application:

Surgical masks, surgical respirators, and barrier face coverings, both reusable and disposable.
Masks manufactured with nano-object enhanced media, irrespective of fabrication technique.

Test Methodology:

Specifies air flow-based testing to monitor the release of nano-objects from mask media under controlled conditions.
Includes procedures for pre-conditioning specimens, air flow measurement, and use of standardized sampling filters and instruments like condensation particle counters and differential mobility analyzing systems.

Sample Collection and Characterization:

Guidance on sampling approaches, including filter-based and real-time monitoring methods for both upstream and downstream measurement.
Description of key qualitative and quantitative analysis techniques-such as electron microscopy, X-ray spectroscopy, atomic force microscopy, and mass spectrometry-to assess nano-object size, shape, and chemical composition.

Classification and Definitions:

Defines core terminology such as nano-object, nanomaterial, nanofibre, and mask types to ensure consistency across industry practice.

Reporting Requirements:

Standardized reporting framework to facilitate clear communication between mask manufacturers, users, and regulators regarding the nature and risk of nano-object release.

Applications

Product Safety Assessment: Enables manufacturers and regulatory bodies to assess and document the potential nano-object release from mask media, supporting health and safety compliance.

Quality Control and Certification: Provides guidance for quality assurance of nano-enabled masks by specifying test conditions and performance criteria, aiding in certification processes.

Research and Development: Facilitates consistent evaluation during the development of new mask materials and technologies containing nanomaterials.

Market Communication: Assures end-users and procurement agencies of mask performance regarding nano-object containment, promoting informed purchasing decisions and manufacturer accountability.

Related Standards

ISO 16890-2: Air filters for general ventilation - Measurement of fractional efficiency and air flow resistance.

ISO 26824: Particle characterization of particulate systems - Vocabulary.

ISO 27891: Calibration of condensation particle counters.

ISO/TS 23302: Requirements and recommendations for the identification of measurands characterising nano-objects.

ASTM F2100: Performance of materials used in medical face masks.

EN 1822-4: High efficiency air filters (EPA, HEPA, ULPA) - Determining leakage of filter elements.

ISO 15167: Determination of particulate content of middle distillate fuels – Laboratory filtration.

Conclusion

Adopting ISO/TS 11353:2026 ensures robust and consistent detection and characterization of nano-object release from mask media, addressing important aspects of health, safety, and product quality in nanotechnology-enabled face coverings. Implementation across the industry supports best practices in manufacturing, testing, and compliance, and strengthens confidence in nanotechnology applications for personal protective equipment. For maximum benefit, manufacturers and test laboratories should integrate this standard into their existing quality and safety frameworks.

ISO/TS 11353:2026 PDF

Abstract

Похожие стандарты

Overview

Key Topics

Applications

Related Standards

Conclusion

Технические детали

SIST EN ISO 16890-2:2022

Air filters for general ventilation - Part 2: Measurement of fractional efficiency and air flow resistance (I…

BS ISO 26824:2013

Particle characterization of particulate systems. Vocabulary

ISO 2789:1991

Information and documentation — International library statistics

SIST-TS CEN ISO/TS 23302:2022

Nanotechnologies - Requirements and recommendations for the identification of measurands that characterise na…

ISO 15167:1999

Petroleum products — Determination of particulate content of middle distillate fuels — Laboratory filtration…