prEN ISO 22615
(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
Relations
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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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
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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
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 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
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
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.
iv
ISO/DIS 22615:2025(en)
Introduction
Protective clothing against infective agents has two main functions:
— To minimize or prevent infective agents from reaching the (possibly injured) skin;
— To prevent the spreading of infective agents to other people and other situations, e.g. eating or drinking,
close contact with others when the person has taken his protective clothing off.
In many work situations, e.g. microbiological laboratories, biotechnological production, etc. the infective
agents can be contained and the risk of exposure is limited to the occurrence of an accident. In these
situations, the agents, to which the worker can be exposed, are usually well known. In other types of work,
the organisms cannot be contained, exposing the worker continuously to the risk of infection by biological
agents. This happens e.g. in sewage work, waste treatment, caring for animals infected with zoonotic agents,
emergency clean-up, treatment of hospital risk waste etc. In these situations, the agents the workers are
exposed to, may not be known, although possible risks can be assessed.
During pandemics, depending on the virus risk category, viral transmission means and the working
environment, surgical gowns may not always necessarily provide adequate protection of the wearer (either
due to the design or the nature of the material & seams).
Micro-organisms are a very heterogeneous group of organisms as to their size, shape, living conditions,
infective dose, survival abilities and many other parameters. Their size alone can vary from 30 nm
(poliovirus) to 5 µm to 10 µm (bacteria) and even larger (most fungi). A hazard classification of micro-
organisms can be found in European Directive 2000/54/EEC (on the protection of workers from the risk
related to exposure to biological agents at work).
Due to the heterogeneity of micro-organisms, it is not possible to define performance criteria on the basis of
risk groups, nor on the type of micro-organism. Also it may not be possible to define exactly the organisms
the worker is exposed to. Hence the test methods specified in this standard focus on the medium containing
the micro-organism, such as a liquid, an aerosol or a solid dust particle. A risk analysis should determine
which ones of these risks are present in a given situation.
[1] [2]
This standard was inspired by EN 14126:2003 and ANSI AAMI PB 70:2022 .
v
DRAFT International Standard ISO/DIS 22615:2025(en)
Protective clothing — Performance requirements and test
methods for protective clothing against infective agents
1 Scope
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 based on either the ISO 16602 series or on
ISO/DIS 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/DIS 20384.
For products intended for the dual use as both a PPE and as a medical gown, both this document and the
ISO/DIS 20384shall 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/DIS 20384.
This document is 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 811:2018, Textiles — Determination of resistance to water penetration — Hydrostatic pressure test
ISO 11092:2014, Textiles — Physiological effects — Measurement of thermal and water-vapour resistance under
steady-state conditions (sweating guarded-hotplate test)
ISO 11610:2023, Protective clothing — Vocabulary
ISO 11737-1:2018/Amd 1:2021, Sterilization of health care products — Microbiological methods — Part 1:
Determination of a population of microorganisms on products — Amendment 1
ISO 13688:2013, Protective clothing — General requirements
ISO 13688:2013/Amd 1:2021, Protective clothing — General requirements — Amendment 1
ISO/DIS 16602-1, Protective clothing for protection against chemicals — Classification, labelling and
performance requirements — Part 1: General requirements
ISO/CD 16602-1, Protective clothing for protection against chemicals — Classification, labelling and performance
requirements — Part 1: General requirements
ISO/DIS 16602-2, Protective clothing for protection against chemicals — Classification, labelling and
performance requirements — Part 2: Physical test methods, classification and requirements
ISO/DIS 22615:2025(en)
ISO/CD 16602-2, Protective clothing for protection against chemicals — Classification, labelling and
performance requirements — Part 2: Physical test methods, classification and requirements
ISO/CD 16602-4, Protective clothing for protection against chemicals — Classification, labelling and
performance requirements — Part 4: Test methods, classification and requirements for specific designs and
ensemble components including gloves, footwear, and respirators
ISO/DIS 16602-4, Protective clothing for protection against chemicals — Classification, labelling and
performance requirements — Part 4: Test methods, classification and requirements for specific designs and
ensemble components including gloves, footwear, and respirators
ISO/CD 16602-5, Protective clothing for protection against chemicals — Classification, labelling and
performance requirements — Part 5: Garment test methods, classification and requirements
ISO/DIS 16602-5, Protective clothing for protection against chemicals — Classification, labelling and
performance requirements — Part 5: Garment test methods, classification and requirements
ISO 16604:2004, Clothing for protection against contact with blood and body fluids — Determination of
resistance of protective clothing materials to penetration by blood-borne pathogens — Test method using Phi-X
174 bacteriophage
ISO 17491-4:2024, Protective clothing — Test methods for clothing providing protection against chemicals —
Part 4: Determination of resistance to penetration by a spray of liquid (spray test)
ISO 18695:2007, Textiles — Determination of resistance to water penetration — Impact penetration test
ISO 18695:2007, Textiles — Determination of resistance to water penetration — Impact penetration test
ISO/CD 20384, Surgical clothing and drapes — Requirements and test methods
ISO/DIS 20384, Surgical clothing and drapes — Requirements and test methods
ISO/CD 20384, Surgical clothing and drapes — Requirements and test methods
ISO/DIS 22610, Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and
equipment — Test method to determine the resistance to wet bacterial penetration
ISO 22612:2005, Clothing for protection against infectious agents — Test method for resistance to dry microbial
penetration
EN 13795-1:2019, Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
3 Terms and definitions
For the purposes of this document, the following terms and definitions given in ISO 11610:2023, as well as the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
area
area of protective apparel
3.1.1
critical area
area where direct contact with blood, body fluids, and other potentially infectious materials is most likely
to occur
ISO/DIS 22615:2025(en)
3.1.2
less critical area
area less likely to be involved in the transfer of infective agents with the product
[SOURCE: EN 13795-1:2019, 3.5]
3.2
bacteriophage
type of virus which infects bacteria
Note 1 to entry: In this test method, the bacteriophage is Phi-X174. The Phi-X174 bacteriophage is not pathogenic to
humans, but serves to simulate viruses that are pathogenic to humans.
3.3
body fluid
liquid produced (secreted or excreted) by the body
Note 1 to entry: For the purpose of this document, body fluids include those liquids potentially infected with blood-
borne pathogens, including, but not limited to, blood, semen, vaginal secretions, cerebrospinal fluid, synovial fluid
and peritoneal fluid, amniotic fluid, saliva in dental procedures, and any body fluid that is visibly contaminated with
blood, and all body fluids in situation where it is difficult or impossible to differentiate between body fluids
[SOURCE: ISO 16604:2004, 3.6]
3.4
colony forming unit cfu
unit by which the culturable number of microorganisms is expressed
Note 1 to entry: The culturable number is the number of microorganisms, single cells or aggregates, able to form
colonies on a solid nutrient medium.
3.5
infective biological agents
micro-organisms, including those which have been genetically modified, cell cultures and human
endoparasites, that have been shown to potentially cause infections, acute disease or long-term damage to
human health/human body
3.6
medical gown
gown used in health care facilities to provide various levels of protection to the wearer depending on the
intended use
EXAMPLE Medical gowns include isolation gowns, surgical gowns, medical coveralls, patient gowns, etc.
3.7
point of attachment
area at which an attachment occurs providing a physical connection between one thing that is attached to
another (e.g. areas where belts, ties, pockets, snaps, etc. are attached)
[2]
[SOURCE: ANSI AAMI PB 70:2022 ]
3.8
protective clothing against infective biological agents
combined assembly of garments, intended to afford protection to the skin against exposure to or contact
with infective biological agents
3.9
surgical gown
gown worn by clinical staff to minimize transmission of infective agents during the peri-operative process,
particularly within either the operating room or the Post Anaesthesia Care Unit (PACU)
Note 1 to entry: Medical gowns include surgical gowns. However some types of medical gowns e.g. Isolation gowns are
not intended to be used as surgical gowns.
ISO/DIS 22615:2025(en)
3.10
synthetic blood
challenge agent that is intended to simulate the liquid properties of blood
[3]
[SOURCE: AAMI PB 70:2022 ]
4 General
4.1 Basic requirements
Any garment and its components shall meet the relevant requirements of:
— ISO 13688:2013/ISO 13688:2013/Amd 1:2021and ISO 16602 series, or
— ISO 13688:2013/ISO 13688:2013/Amd 1:2021 and ISO/DIS 20384, or
— ISO 13688:2013/ISO 13688:2013/Amd 1:2021, ISO 16602 series and ISO/DIS 20384,
in addition to the requirements set in this document.
The garment can provide either partial body protection or full body protection as defined in ISO/DIS 16602-1
sub-clause 7.2.1 and 7.3.1.
NOTE TheISO 13688:2013/ ISO 13688:2013/Amd 1:2021and ISO/DIS 20384route does not require chemical
testing.
The value of each property defined in 4.2, 4.4 and 4.5 and which shall be used for performance classification,
shall be determined in accordance with Annex C
Donning and doffing instructions shall be provided in the IFU in clause 6, list item 3) based on the guidance
given in Annex F.
4.2 Barrier properties
4.2.1 General
The classification for the requirements of this document shall be based on the performance characteristics
as defined in this document and in the minimum requirements of the standards mentioned in 4.1.
In addition, the classification for the requirements this document shall indicate the performance of the
critical and less-critical areas of the garment. This document acknowledges the fact that not all areas of the
product are involved in the transfer of infective agents to the same extent. Annex D explains how to indicate
the location of the critical areas and less-critical areas that shall be marked in the garment according to 5,
list item e).
4.2.2 Critical areas
Critical area properties are those properties which are considered critical for the intended risk against for
which the product protects as defined in 6, list item 1). They shall meet all the requirements of clauses 4.4,
4.5, and 4.6 in addition to the requirements of 4.2.3.
The performance of seams between and within critical areas shall meet the requirements for critical areas.
4.2.3 Less-critical areas
The less-critical area properties are those properties which are considered less-critical for the intended
risk against which the product protects as defined in 6, list item 1). These areas shall meet the minimum
requirements of the one of the standards as defined in 4.1(ISO 16602 series, ISO/DIS 20384, or both). This
document sets additional minimum requirements in clauses 4.4.1, 4.4.2and 4.5.6.
ISO/DIS 22615:2025(en)
The performance of seams between critical and less-critical areas shall meet at least the requirements of the
adjacent less-critical area.
4.3 Pre-treatment by cleaning and conditioning for testing
4.3.1 Cleaning
Before each test, all protective clothing against biological infective agents samples, with the exception of
single use protective clothing, shall undergo pre-treatment by cleaning. For single use garments, testing
shall be carried out on new material or a new garment.
For materials, which require pre-treatment by cleaning, the performance classification shall be based on
the lowest/worst performance classification obtained on testing as new (not pre-treated) and pre-treated
materials. If insufficient documented evidence (i.e. if there is no previous test data) is available to determine
whether the test shall be performed as new or pre-treated, the test shall be performed in both conditions.
Where applicable according to manufacturer’s instructions, the cleaning shall be in line with the
manufacturer’s instructions, on the basis of standardized procedures. If the number of cleaning cycles is not
specified, the tests shall be carried out after 5 cycles of cleaning. Each cycle shall consist of one wash cycle
and one dry cycle carried out as indicated by the manufacturer’s instructions.
Manufacturer’s instructions with regard to number of cleaning cycles, cleaning procedures shall be
observed. Field decontamination or decontamination for disposal is excluded.
4.3.2 Deterioration of repellency by cleaning
Where the finishing, applied to improve or maintain the repellency for liquids resistance performance of the
garment, can be deteriorated by the cleaning procedures indicated by the manufacturer, the manufacturer
shall indicate the maximum number of cleaning cycles that can be carried out before the garment needs to
be re-treated or re-impregnated to restore its performance.
Testing according to 4.5 shall be carried out before the cleaning cycle for which the manufacturer guarantees
the performance.
For example, if the instructions state “re-impregnation during each third cleaning cycle”, tests shall be
performed after the second cleaning cycle, i.e. before re-impregnation. Then after reimpregation is applied,
the test should be performed again in order to demonstrate meeting the requirement.
If the instructions state “re-impregnation after each cleaning cycle”, the tests shall be performed on new
items. Later, the item shall be cleaned, reimpregnation is applied and test repeated again in order to
demonstrate meeting the requirement.
In all cases, cleaning shall be according 4.3.1.
4.3.3 Sterile
Re-usable garments shall be tested for the requirements in 4.5 and to preconditioning according to 4.3.1 and
4.3.2 (if relevant) and after sterilization processing specified by the manufacturer.
Single use garment shall be tested for the requirements in 4.5 in sterile state as sold.
4.3.4 Conditioning
All samples shall be conditioned by storage at (23 ± 3) °C and (60 ± 10) % relative humidity for at least 24 h.
Testing of test specimen shall commence within 15 min of removing the sample or test specimen from the
conditioning atmosphere.
This conditioning requirement takes priority over any conflicting conditioning requirements in the
individual test method standards.
ISO/DIS 22615:2025(en)
If the product is intended to be used after sterilisation, conditioning shall not be required prior to testing.
4.3.5 Testing temperature
Unless otherwise specified in this document, all testing shall be conducted at the same conditions used for
conditioning specified in 4.3.4, with the exception for the ISO 18695:2007in clause 4.5.6.
4.4 Materials requirements
4.4.1 Material physical requirements
The materials shall be tested and meet at least class 1 for the core physical properties, described in Table 1,
in accordance with the requirements clause 5 of ISO/DIS 16602-1 and meeting the minimum class when
tested in accordance to ISO/DIS 16602-2.
Table 1 — Core physical requirements
Core Physical Requirements
Abrasion
Flex cracking
Tear
Tensile
Puncture
Seam strength
4.4.2 Material ignition resistance requirements
The materials shall be tested for ignition resistance requirements of clause 4.10.2 of ISO/DIS 16602-2. If the
materials do not meet this requirement this shall be reported in the manufacturer's instructions (clause 6).
4.4.3 Material cleanliness requirements (optional)
When the protective clothing is intended for use in laboratory environments or for use in health care
settings, the garment shall additionally be tested to ISO 11737-1:2018/Amd 1:2021 for microbial cleanliness
and the performance should be < 300 CFU/100 cm .
4.4.4 Material comfort indicator
Where the manufacturer claims the garment material to be breathable, the resistance to evaporative
transfer (water vapour resistance) shall be tested according to ISO 11092:2014 (See Annex B). The mean R
et
result shall be included in the manufacturer’s instructions for use (see 6, list item i)).
NOTE The risk assessment of the end user is needed to determine the limited time of use, depending of the R
et
result of of the garment.
4.5 Performance requirements against penetration by infective biological agents
4.5.1 General
The test methods listed below focus on the medium containing the micro-organism, such as a liquid, an
aerosol or a solid dust particle. The external side of the tested clothing material shall be facing the media
containing the micro-organisms.
For the materials meeting critical area's properties that protect against the risk described in 4.2, these
critical areas shall meet at least Class 1 of at least one of the tests/properties listed in the 4.5.2 - 4.5.5. Where
for the 4.5.2 - 4.5.5 a Class 1 is not achieved or not tested, this should be indicated by "X". For the seam
ISO/DIS 22615:2025(en)
requirement in 4.5.6, at least a Class 1 shall be achieved. Protective clothing made of multiple detachable
layers, the lowest performance class of any of the layer materials shall be used.
4.5.2 Resistance to penetration by blood-borne pathogens using Phi-X174 bacteriophage under
pressure
When tested in accordance with ISO 16604:2004 procedure C or D, three specimens of material shall be
classified according to the levels of performance given in Table 2 as obtained in the bacteriophage test.
Specimen shall exhibit no more than 10 PFU/mL of the Phi-X174 bacteriophage in the assay to pass the test.
Thin test specimens may be affected due to their deformation or creasing in the cell sealing area when 13.6
Nm torque is used on the bolts. Lower torque closure of the cell is permitted as long as no leakage occurs
during testing.
[4]
NOTE The synthetic blood test (ISO 16603:2004 is used for screening purposes to help predict the level where a
penetration can be expected when performing the bacteriophage test (ISO 16604:2004).
Table 2 — Classification of resistance to penetration by blood-borne pathogens using Phi-X174
bacteriophage under pressure (ISO 16604)
Class Pressure at which the material passes the test
6 20 kPa
5 14 kPa
4 7 kPa
3 3,5 kPa
2 1,75 kPa
a
1 0 kPa
a
this means that the material is only exposed to the hydrostatic pressure of the liquid in the test cell
4.5.3 Resistance to penetration by infective agents due to mechanical contact with substances
containing contaminated liquids.
When tested in accordance with ISO/DIS 22610, 5 specimens of the material shall be classified according to
the levels of performance given in Table 3.
Table 3 — Classification of resistance to penetration by infective agents due to mechanical contact
with substances containing contaminated liquids
Class I
B
3 ≥ 6,0
2 4,0 ≤ I < 6,0
B
1 2,8 < I < 4,0
B
NOTE I 6,0 for the purpose of this document means: no penetration. I 6,0 is the maximum achievable value.
B B
4.5.4 Resistance to penetration by contaminated liquid aerosols
When the 8 specimens of the material are tested in accordance with Annex A, the average results of the
material shall be used to classify according to the levels of performance given in Table 4.
ISO/DIS 22615:2025(en)
Table 4 — Classification of resistance to penetration by infective agents due to mechanical contact
with substances containing contaminated liquids
Class Penetration ratio (log)
3 Log ≥ 4,5
2 3,0 ≤ log < 4,5
1 1,0 < log < 3,0
4.5.5 Resistance to penetration by contaminated solid particles
When tested in accordance with ISO 22612:2005, 12 specimens of the material shall be tested. The
classification, according to the levels of performance given in Table 5 shall be based on the arithmetic mean
of the valid results.
Test conditions: challenge concentration 10 CFU/g talcum and 30 min vibration time.
Table 5 — Classification of resistance to penetration by contaminated solid particles
Class Penetration (log cfu)
3 Log cfu ≤ 1
2 1 < log cfu ≤ 2
1 2 < log cfu ≤ 3
4.5.6 Fabric and seam requirement for penetration
In order to provide adequate biological protection, seams, points of attachment such as ties, and fabrics shall
be tested and classified according to the levels of performance given for the Critical or Less-Critical area
that indicated in Table 6 and the paragraphs below.
The performance classification shall be determined based on the test method result calculation in Table 6
using either the lowest single value for the ISO 16604:2004 and the average for the ISO 811:2018and
ISO 18695:2007. The results shall be provided in the IFU (6, list item h)).
Table 6 — Classification of resistance to penetration
Class Test method Test Items Performance clas- Critical Area Less-Critical Area
sification
6 ISO 16604 seams lowest single Class 6 of Table 2 At least class 1 of
value Table 2
5 ISO 16604 seams lowest single At least class 5 of At least class 1 of
value Table 2 Table 2
4 ISO 811 seams and fabric average ≥ 100 cm H O ≥ 10 cm H O
2 2
3 ISO 811 seams and fabric average ≥ 50 cm H O ≥ 10 cm H O
2 2
2 ISO 811 seams and fabric average ≥ 10 cm H O ≥ 10 cm H O
2 2
1 ISO 18695 seams and fabric average ≤ 4,5 g ≤ 10 g
NOTE 1 Class 5 and 6 are only tested for seams in this sub-clause as fabrics are already covered in sub-clause 4.5.2.
For Class 1 (Critical area and Less-Critical area), five specimens of both the seams and the fabric are to be
tested and evaluated according to ISO 18695:2007, tested at a temperature of (27 ± 1) °C.
For Class 2-4, the hydrostatic head according to ISO 811:2018 of 5 specimens, of both the seams and the
fabric, shall be determined and by and applied under the following test conditions and supplementary
instructions:
— the test area shall be 100 cm ;
— the rate of increase of water pressure shall be 60 cm H O/min;
ISO/DIS 22615:2025(en)
— the side of the product in contact with the test liquid shall be the outer side;
— a support screen may be applied. A piece of netting, 20 cm x 20 cm, with approximately 3 cm diameter
holes may be used as fabric support. If a net support is used this shall be reported.
— for highly stretchable material the test is finished after the requirement value + 10 % has been reached
NOTE 2 When materials and components are tested according to ISO 811, it is important to position the test
specimens the same way every time. Seams should be centred across the width of the specimen. Any points of
attachment should be positioned in the centre of the specimen.
For Class 5 and 6, the same procedure described in 4.5.2 (ISO 16604:2004) shall be used for testing the
seams. Class 5 and 6 can be attained for the seams only if the fabrics meet one of the classes of respectively
to 4.5.2 for either or both the Critical and the Less-Critical areas.
4.6 Garment test requirements
Protective clothing against infective biological agents shall fulfil one of garment test requirements specified
in ISO/DIS 16602-4 clause 4.4, but as a minimum requirement the one specified in Table 7. The appropriate
symbol shall be provided for the garment test according to ISO/DIS 16602-1 clause 7.1-7.3.
For partial body, the garment test shall be performed according to and meet the requirements of
ISO/DIS 16602-1clause 7.3.2 (Table 7)
Table 7 — Minimum garment test for biological protection
Garment Design Whole suit test standard Relevant clause in ISO/DIS 16602-4
and ISO/DIS 16602-5
Limited liquid penetration resistance ISO 17491-4:2024Method A ISO/DIS 16602-4clause 4.4.2.1 Table 3
(low level spray test) (former Type 6) (Design 3) & ISO/DIS 16602-5,
clause 6.4.4
Partial Body protection ISO/DIS 16602-1clause 7.3 and the See relevant information in ISO/
relevant information in ISO/DIS DIS 16602-4 clause 4.4.2.1 Table 3
16602-5in the next column. (Design 3) and ISO/DIS 16602-5
clause 6.4.1.1 and 6.4.4
5 Marking
The clothing shall be marked in accordance with the applicable requirements of the ISO 13688:2013/Amd
1:2021, and relevant standard for ISO DIS 16602 series or ISO/DIS 20384or both (see 4.1) in addition to the
following:
The marking of protective clothing against infective agents shall contain the following additional
information:
a) The name, trademark or other means of identification of the manufacturer;
b) the manufacturer's type, identification or model number;
c) the number and year of this document under the pictogram of Figure 1;
d) the pictogram and required marking of ISO DIS 16602 series or the stadnard number (with year) of
ISO/DIS 20384, or marking of both standards
— In case the of ISO DIS 16602 series or the ISO/DIS 20384to meet the requirements
of this document or both, the garment test symbol of the mist test (see
ISO/DIS 16602-1, Annex B.1.5) shall be provided as part of the marking (see pictogram Figure 1).
If another of the garment test is used as specified in 4.6, that the relevant symbol shall be applied.
ISO/DIS 22615:2025(en)
Figure 1 — Pictogram liquid mist (low level spray) resistance test (ISO 7000-pending)
— for partial body, the PB symbol shall be placed underneath the pictogram for biological protection
(Figure 2).
e) a pictural description shall be provided to indicate the critical areas and non-critical areas, see
Figure D.1
f) the year of manufacture, and also the month of manufacture if the expected shelf-life of the clothing is
less than 24 months. This information may be marked on every commercial packaging unit instead of
being marked on every item of clothing;
g) the pictogram in Figure 2 “protection against biological hazard” ISO 7000-2491 shall be used. The
additional information of the applicable class code for the test in 4.5.2 - 4.5.6 and optionally from
cleanliness 4.4.3 shall be provided in the order given in the examples in Figure 3) and in Table 8;
Figure 2 — Pictogram for biological protection
4 6 2 3 5 C (needs to be centered)
Figure 3 — Example of marking (example 1)
Three examples of marking
ISO/DIS 22615:2025(en)
Example 1 4 6 2 3 5 C
Examp
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