National foreword

This Published Document is the UK implementation of ISO/TS 11353:2026.

The UK participation in its preparation was entrusted to Technical Committee NTI/1, Nanotechnologies.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

This publication is not to be regarded as a British Standard.

Compliance with a Published Document cannot confer immunity from legal obligations.

This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 January 2026.

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO document should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.

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

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

Introduction

Increasing air pollution and the proliferation of airborne pathogens such as coronavirus are among the most important threats to the global environment and human health. There are three main routes for contaminants (aerosols, bio aerosols, gases and vapours) to enter the body, including respiratory system, dermal and ingestion. Of these routes, the respiratory system is the most important and dominant way of entry.^[1^]-[3^] Therefore, protection of the respiratory system is of particular importance, justifying the use of mask media of a high level of protection. The emergence of the coronavirus pandemic and airborne particulate matter (PM), pollution has led to remarkably high demand for face masks and, as a result, the market for protective face masks has significantly increased. In this regard, polymeric fibrous media have been developed. Fibrous media containing nano-objects, such as either nanofibers or nanoparticles or both, have shown enhanced performance in trapping ultrafine particles, microbes and viruses, at lower pressure drops compared to previous types (mask media without nano-objects. Nano-objects can be coated on the surface of face mask fibres or nanofibres, or can also be embedded within the polymeric fibres or nanofibres themselves. Two major production methods for face mask fibrous media, includes the melt blowing and electrospinning processes. Both processes involve the production of fibres or nanofibres that can serve as a matrix where nano-objects can be embedded or surface-applied. Despite the above-mentioned performance advantages, face mask media containing nano-objects can potentially lead to unforeseen environmental and human health hazards due to the possible release of nano-objects during their life cycle. Releases of component nano-objects from face masks can occur as a result of their design, manufacture, misuse or improper handling.

Nano-objects can be released into different media (such as air, sweat, effluent water) during product use and care.^[4^],[5^] Generally, data on the fraction of nano-objects release from textile materials and products, especially into the air, is limited. Research shows that the total amount of nanoparticles released from investigated textiles ranges from less than 1 % to nearly 100 %, depending on the content of nanoparticles contained within the textiles. In some textiles, the amount of nanoparticle release was lower than the detection limit of the implemented measuring equipment.^[6^],[7^] The nature of the fabric is also one of the other factors affecting the release of nanoparticles. Among the investigated textiles, those with synthetic fibres showed the highest release.^[6^],[7^] Furthermore, the release behaviour of particles from a matrix depends on how the particles are attached or embedded in it.^[8^] Currently, no technical standard exists in the public domain to detect the possible release of component nano-objects from face masks.

This document aims to fill this gap by specifying a test method for detection of nano-objects that can be released from surgical masks, surgical respirators and barrier face coverings containing nanomaterial(s). The release is only investigated by applying an air flow to the mask media, but not by contact to other media, e.g. liquids or skin. In addition, this document also describes the sampling procedure and qualitative characterization methods for released nano-objects. Moreover, the development of this document will facilitate communication between user and manufacturer or producer and lead to the enhancement of the related market.

1 Scope

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.

2 Normative references

3 Terms and definitions

4 Abbreviation terms

5 Classification

6 Test requirements

6.1 Qualification of nano-objects in the mask media

6.2 Test rig components

7 Test procedure

7.1 Pre-conditioning

7.2 Air flow measurement

7.3 Sampling and monitoring of released nano-objects

8 Determination of qualitative properties of released nano-objects

8.1 Measurands related to chemical measurement of nano-objects

8.2 Measurands related to size and shape measurement of nano-objects

9 Reporting

9.1 General information

9.2 Mandatory characteristics

Bibliography

PD ISO/TS 11353:2026

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

Current

Published:

31 Jan 2026