prEN 18178-1

SLOVENSKI STANDARD
01-september-2025
Naprave za preprečevanje respiratornih okužb za lastno zaščito in zaščito tretjih
oseb - 1. del: Zahteve in označevanje
Respiratory infection prevention devices for self- and third-party protection - Part 1:
Requirements and marking
Atemwegsinfektionsschutzgeräte für den Selbst- und Fremdschutz - Teil 1:
Anforderungen und Kennzeichnung
Dispositifs de prévention des infections respiratoires pour la protection individuelle et de
tiers - Partie 1 : Exigences et marquage
Ta slovenski standard je istoveten z: prEN 18178-1
ICS:
13.340.20 Varovalna oprema za glavo Head protective equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2025
ICS 13.340.20
English Version
Respiratory infection prevention devices for self- and
third-party protection - Part 1: Requirements and marking
Dispositifs de prévention des infections respiratoires Atemwegsinfektionsschutzgeräte für den Selbst- und
pour la protection individuelle et de tiers - Partie 1 : Fremdschutz - Teil 1: Anforderungen und
Exigences et marquage Kennzeichnung
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 205.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 18178-1:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms, definitions and abbreviations . 7
3.1 Terms and definitions . 7
3.2 Abbreviations . 7
4 Requirements . 7
4.1 General. 7
4.2 Inward protection level . 8
4.3 Total outward leakage (TOL) . 9
4.4 Work of breathing and breathing resistance . 9
4.5 Bacterial filtration efficiency (BFE) . 10
4.6 Particle filter efficiency . 10
4.7 Carbon dioxide . 11
4.8 Facial expression visibility . 11
4.9 Resistance to flame – Single burner dynamic . 12
4.10 Field of vision . 12
4.11 Microbial cleanliness (bioburden) . 12
4.12 Splash resistance . 13
4.13 Biocompatibility . 13
4.13.1 General. 13
4.13.2 Release of particles . 13
4.13.3 Release of VOCs . 13
4.13.4 Release of leachables in condensate . 13
4.13.5 Release of irritants . 13
4.14 Wearer injury and discomfort. 13
4.15 Fixation to head and face . 14
4.16 Auditory interference. 14
4.16.1 Speech . 14
4.16.2 Hearing . 14
4.17 Compatibility with other devices . 14
4.18 Fogging and dripping . 14
4.19 Practical performance. 15
5 Conditioning . 15
5.1 Simulated wearing treatment . 15
5.2 Temperature conditioning . 15
6 Information to be supplied by the manufacturer . 16
7 Packaging . 16
8 Marking of the product . 18
9 Scientific references. 18
Annex ZA (informative) Relationship between this European Standard and General Safety
and Performance Requirements of Regulation (EU) 2017/745 [OJ L 117] aimed to be
covered . 19
Annex ZB (informative) Relationship between this European Standard and the essential
health and safety requirements of Regulation 2016/425/EU [2016 OJ L81] aimed to
be covered . 21
Bibliography . 22
European foreword
This document (prEN 18178-1:2025) has been prepared by Technical Committee CEN/TC 205 “Non-
active medical devices”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA and Annex ZB, which are an integral
part of this document.
The EN 18178 series consists of the following parts, under the general title Respiratory infection
prevention devices for self- and third-party protection:
— Part 1: Requirements and markings
— Part 2: Test methods
— Part 3: Sustainability, human factors and rationales
— Part 4: Selection and use
— Part 5: Classification
Introduction
During outbreaks of respiratory infection, a device that protects in both directions of breathing (outward
and inward) may be required. In environments subject to the Medical Device (MD) Regulation (EU)
2017/745, the standard EN 14683 applies. In environments subject to the Personal Protective Equipment
(PPE) Regulation (EU) 2016/425, there is a range of applicable standards (e.g. EN 149). In environments
where these EU Regulations are not applicable, the General Product Safety Directive (2001/95/EC)
(GPSD) applies, supported by CEN/TS 17553. This document aims to define requirements for devices to
prevent respiratory infection that fall under both MDR and PPE regulations.
The EN 18178 series is a user- and performance-oriented standard series.
A product, regardless of design, that meets all the requirements may be used as a respiratory infection
prevention device (RIPD) and provides protection against infectious agents at the level described in the
classification (see EN 18178-5).
Essential parts of the EN 18178 series are this document, EN 18178-2 and EN 18178-5.
This document defines all requirements for a product to be considered as a RIPD.
In EN 18178-2 all corresponding test methods to each requirement can be found and in EN 18178-5 the
classification is defined. The resulting classification is part of the mandatory marking. Since the target
group is the general population, it is necessary to supplement this mandatory marking with an
immediately recognizable, clear visual marking that allows a safe and appropriate selection of a product
requiring minimal training.
Supplementary parts of the EN 18178 series are EN 18178-3 and EN 18178-4.
EN 18178-3 contains the references and descriptions of the ‘human factors’ that were used to set the limit
values in this document. Rationales about the selected test methods, e.g. representation of infective
agents, are given in part 3 as well.
Furthermore, aspects of environmental compatibility and sustainability are reflected in EN 18178-3.
EN 18178-4, as informative ‘selection and use’, offers a proposal for the correct selection of RIPD for
applications in accordance with the classification.
1 Scope
This document specifies the minimum functional and performance requirements for respiratory
infection prevention devices (RIPDs).
RIPDs are intended to reduce the emission of infective agents from the user’s airways into the
environment, and also reduce exposure to the user from inhalation of infective agents.
RIPDs are intended for use by everybody.
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.
prEN 18178-2:2025, Respiratory infection prevention devices for self- and third-party protection — Part 2:
Test methods
EN 14683:2025, Medical face masks — Requirements and test methods
EN ISO 16972:2020, Respiratory protective devices — Vocabulary and graphical symbols (ISO 16972:2020)
EN IEC 60812:2018, Failure modes and effects analysis (FMEA and FMECA) (IEC 60812:2018)
prEN ISO 10993-1:2024, Biological evaluation of medical devices — Part 1: Requirements and general
principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024)
EN ISO 10993-23:2021, Biological evaluation of medical devices — Part 23: Tests for irritation (ISO 10993-
23:2021)
EN ISO 18562-2:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications
— Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024)
EN ISO 18562-3:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications
— Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024)
EN ISO 18562-4:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications
— Part 4: Tests for leachables in condensate (ISO 18562-4:2024)
ISO 17420-1:2021, Respiratory protective devices — Performance requirements — Part 1: General
ISO 17420-2:2021, Respiratory protective devices — Performance requirements — Part 2: Requirements
for filtering RPD
ISO 16900-1:2019, Respiratory protective devices — Methods of test and test equipment — Part 1:
Determination of inward leakage
ISO 7000:2019, Graphical symbols for use on equipment — Registered symbols
3 Terms, definitions and abbreviations
3.1 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 16972:2020 and the
following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at https://www.electropedia.org/
3.1.1
facial morphology
form and structure of a human face
3.1.2
respiratory infection protection device
RIPD
device intended to reduce the emission of infective agents from the user’s airways into the environment,
and also reduce exposure to the user from inhalation of infective agents
3.2 Abbreviations
BFE bacterial filtration efficiency
CFU colony forming unit
FMEA failure mode and affects analysis
MD medical device
IFU instructions for use
PM particulate matter
PPE personal protective equipment
TIL total inward leakage
TOL total outward leakage
VOC volatile organic compound
BTPS body temperature pressure saturated
4 Requirements
4.1 General
RIPDs shall be tested in accordance with prEN 18178-2:2025. The numbering within this clause is aligned
with prEN 18178-2:2025, Clause 4.
Where it is required in a specific clause, it shall be declared that a risk assessment, e.g. a Failure Modes
and Effect Analysis (FMEA), according to EN IEC 60812:2018, concerning these specific requirements has
been conducted.
4.2 Inward protection level
The results of the total inward leakage (TIL) test determine the protection level of the RIPD as given in
Table 1.
Table 1 — Inward protection level
Maximum TIL %
Inward
protection level
Mass
1 > 20
2 20
3 5
4 2
5 1
For tight fitting RIPD, the fit of the RIPD on each test subject shall be assessed prior to TIL testing in
accordance with the information supplied by the RPID manufacturer.
Testing shall be performed in accordance with prEN 18178-2:2025, 4.2.
Testing shall be performed with 15 test subjects.
A maximum number of 35 test subjects shall be assessed in order to select the test panel. If a test panel
of 15 cannot be identified after the fit assessment of 35 test subjects, then the RIPD shall not be tested for
TIL and this fact reported in the test report.
The inward protection level shall be derived as follows:
— Calculate the arithmetic mean of the TIL test results in % for all exercises for each test subject.
— Order all 15 results from smallest to largest. The overall percentage TIL value for the RIPD is
max
equivalent to the second largest result.
RIPDs shall meet the performance of one of the levels in Table 1. Test in accordance with
prEN 18178-2:2025, 4.2, with the following prerequisites:
— each test subject shall use a new, non-conditioned sample;
— sodium chloride aerosol shall be used as attest agent;
— test regime 1 of ISO 16900-1:2019, Annex B, shall be used, except exercise 2A (Hydration);
— there shall be no use of crosswinds.
4.3 Total outward leakage (TOL)
RIPDs shall meet the performance of one of the levels given in Table 2 according to prEN 18178-2:2025,
4.3.
NOTE This requirement is intended to be revised after the Enquiry of this document. Potential users are invited
to comment on this topic.
Table 2 — Outward protection level
Maximum TOL %
Outward
protection level
Mass
1 tba
2 tba
3 tba
The measurement shall be done in accordance with prEN 18178-2:2025, 4.3.
Number of samples and conditioning shall be decided.
4.4 Work of breathing and breathing resistance
RIPD shall not exceed the limits for work of breathing and breathing resistance. The work of breathing
and breathing resistance (peak pressure) shall be calculated from the average pressure volume loop
based on 10 consecutive breathing cycles given in Table 3 according to its level.
The settings for the breathing machine for each work rate are given in Table 3.
Table 3 — Setting of breathing machine at work rates
Flow rate (dynamic sinusoidal) Frequency Tidal volume
Work rate
l/min at BTPS cycles/min l at BTPS
W1 5 with a tolerance of ±3 % 10,0 0,5
W2 10 with a tolerance of ±3 % 10,0 1,0
W3 35 with a tolerance of ±2 % 23,3 1,5
W4 65 with a tolerance of ±2 % 32,5 2,0
Testing shall be performed in accordance with prEN 18178-2:2025, 4.4.
RIPDs shall have a WOB not higher than shown in Table 4.
Table 4 — Level of work of breathing and breathing resistance
Breathing resistance limit (peak
Work of breathing limit
pressures)
Level
[kPa]
[kPa]
Inhalation Exhalation Inhalation Exhalation
1 0,9 0,9 −1,2 1,2
2 0,9 0,9 −1,2 1,2
3 0,7 0,7 1,0 1,0
4 0,5 0,5 0,7 0,7
NOTE See also ISO 17420-2:2021, Table 3.
4.5 Bacterial filtration efficiency (BFE)
The bacterial filtration efficiency (BFE) of the RIPD shall fulfil the requirements of EN 14683:2025 for
type I (≥95 %) or type II (≥98 %).
Table 5 — Bacterial filtration efficiency
Bacterial filtration efficiency (BFE)
Performance level
[%]
1 ≥ 95
2 ≥ 98
Number of samples and conditioning shall comply with EN 14683:2025.
Testing shall be performed in accordance with prEN 18178-2:2025, 4.5.
4.6 Particle filter efficiency
RIPDs shall meet one of the following particle efficiency classes listed in Table 6 when tested.
Table 6 — Particle filter level
Efficiency Penetration
Filter level
% %
5 ≥ 99,99 ≤ 0,01
4 ≥ 99,90 ≤ 0,1
3 ≥ 99,00 ≤ 1,0
2 ≥ 95,00 ≤ 5,0
1 ≥ 80,00 ≤ 20,0
RIPDs shall be tested in accordance with prEN 18178-2:2025, 4.6.
4.7 Carbon dioxide
The carbon dioxide content of the inhalation air shall not exceed an average volume fraction as given in
Table 7. After stabilization, the measurement of at least 10 cycles shall be taken to determine the average.
Within at least 10 cycles the average value of CO at the end
...