oSIST prEN ISO 22615:2025
(Main)Protective clothing - Performance requirements and test methods for protective clothing against infective agents (ISO/DIS 22615:2025)
Protective clothing - Performance requirements and test methods for protective clothing against infective agents (ISO/DIS 22615:2025)
This document specifies requirements and test methods for materials and seams of re-usable and single use protective clothing providing protection of the wearer against infective biological agents. Design criteria, mechanical requirements, and functional fit requirements are basd on either ISO 16602 series or by the ISO 20384 as indicated in this document, while the barrier properties of this document will be additive to ensure the protection against infective biological agents.
NOTE This standard is a standalone standard but using requirements based on ISO 16602 series and ISO 20384.
For products intended for the dual use as both a PPE and as a medical gown, both this document and the ISO 20384 shall apply.
Clothing worn by surgical teams or drapes laid on patients to prevent cross-contamination during surgical interventions are not covered by the scope of this document, but are covered solely by ISO 20384.
This document not applicable to components such as gloves, boots, eye/face protection devices and respiratory protective devices as their performance criteria are given in other standards. However, when these components are either an integral part of the protective clothing ensemble or are tested separately as partial body protection, supplementary requirements are provided in this standard. This document does not cover requirements for antimicrobial treatments for protective clothing.
Schutzkleidung - Leistungsanforderungen und Prüfverfahren für Schutzkleidung gegen Infektionserreger (ISO/DIS 22615:2025)
Habillement de protection - Exigences de performance et méthodes d'essai pour les vêtements de protection contre les agents infectieux (ISO/DIS 22615:2025)
Varovalna obleka - Zahteve za učinkovitost in preskusne metode za varovalno obleko proti povzročiteljem infekcije (ISO/DIS 22615:2025)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2025
Varovalna obleka - Zahteve za učinkovitost in preskusne metode za varovalno
obleko proti povzročiteljem infekcije (ISO/DIS 22615:2025)
Protective clothing - Performance requirements and test methods for protective clothing
against infective agents (ISO/DIS 22615:2025)
Schutzkleidung - Leistungsanforderungen und Prüfverfahren für Schutzkleidung gegen
Infektionserreger (ISO/DIS 22615:2025)
Habillement de protection - Exigences de performance et méthodes d'essai pour les
vêtements de protection contre les agents infectieux (ISO/DIS 22615:2025)
Ta slovenski standard je istoveten z: prEN ISO 22615
ICS:
13.340.10 Varovalna obleka Protective clothing
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
International
Standard
ISO/DIS 22615
ISO/TC 94/SC 13
Protective clothing — Performance
Secretariat: SNV
requirements and test methods for
Voting begins on:
protective clothing against infective
2025-07-14
agents
Voting terminates on:
2025-10-06
Vêtements de protection — Exigences de performance et
méthodes d'essai pour les vêtements de protection contre les
agents infectieux
ICS: 13.340.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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BEING ACCEPTABLE FOR INDUSTRIAL,
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STANDARDS MAY ON OCCASION HAVE TO
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WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
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Reference number
ISO/DIS 22615:2025(en)
DRAFT
ISO/DIS 22615:2025(en)
International
Standard
ISO/DIS 22615
ISO/TC 94/SC 13
Protective clothing — Performance
Secretariat: SNV
requirements and test methods
Voting begins on:
for protective clothing against
infective agents
Voting terminates on:
Vêtements de protection — Exigences de performance et
méthodes d'essai pour les vêtements de protection contre les
agents infectieux
ICS: 13.340.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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Published in Switzerland Reference number
ISO/DIS 22615:2025(en)
ii
ISO/DIS 22615:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General . 4
4.1 Basic requirements .4
4.2 Barrier properties .4
4.2.1 General .4
4.2.2 Critical areas .4
4.2.3 Less-critical areas .4
4.3 Pre-treatment by cleaning and conditioning for testing .5
4.3.1 Cleaning .5
4.3.2 Deterioration of repellency by cleaning .5
4.3.3 Sterile.5
4.3.4 Conditioning .5
4.3.5 Testing temperature .6
4.4 Materials requirements .6
4.4.1 Material physical requirements . .6
4.4.2 Material ignition resistance requirements .6
4.4.3 Material cleanliness requirements (optional) .6
4.4.4 Material comfort indicator .6
4.5 Performance requirements against penetration by infective biological agents .6
4.5.1 General .6
4.5.2 Resistance to penetration by blood-borne pathogens using Phi-X174
bacteriophage under pressure .7
4.5.3 Resistance to penetration by infective agents due to mechanical contact with
substances containing contaminated liquids. .7
4.5.4 Resistance to penetration by contaminated liquid aerosols .7
4.5.5 Resistance to penetration by contaminated solid particles .8
4.5.6 Fabric and seam requirement for penetration .8
4.6 Garment test requirements .9
5 Marking . . 9
6 Information supplied by the manufacturer .11
Annex A (normative) Test method for resistance to penetration by biologically contaminated
aerosols .13
Annex B (informative) Comfort.21
Annex C (normative) Assessment, evaluation and determination of the property values for
rating and for performance classification .22
Annex D (normative) Critical areas and less-critical areas .24
Annex E (informative) Biological Hazards and Risks .26
Annex F (informative) Donning and doffing considerations for clothing design .35
Annex ZA (informative) .39
Bibliography .44
iii
ISO/DIS 22615:2025(en)
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
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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 documents 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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
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rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on 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 the following URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 94, Personal safety - Protective clothing and
equipment, Subcommittee SC 13, Protective clothing.
[1]
This first edition has been draft based on the EN 14126:2003 .
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 atwww.iso.org/members.html.
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