oSIST prEN 18178-2:2025

Respiratory infection prevention devices for self- and third-party protection - Part 2: Test methods

This document specifies the test methods 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 regardless of facial morphology or ability.

Atemwegsinfektionsschutzgeräte für den Selbst- und Fremdschutz - Teil 2: Prüfverfahren

Dieses Dokument legt die Prüfverfahren für Atemwegsinfektionsschutzgeräte (RIPDs) fest.
RIPDs dienen dazu, die Absonderung von infektiösen Keimen aus den Atemwegen des Anwenders in die Umgebung zu verringern und die Exposition des Anwenders durch das Einatmen infektiöser Keime zu reduzieren.
RIPDs sind für die Verwendung durch alle Personen unabhängig von ihrer Gesichtsmorphologie oder ihren Fähigkeiten vorgesehen.

Dispositifs de prévention des infections respiratoires pour la protection individuelle et de tiers - Partie 2 : Méthodes d’essai

Le présent document spécifie les méthodes d’essai pour les dispositifs de prévention des infections respiratoires (DPIR).
Les DPIR sont destinés à réduire l’émission d’agents infectieux des voies respiratoires de l’utilisateur dans l’environnement, et aussi à réduire l’exposition de l’utilisateur à l’inhalation d’agents infectieux.
Les DPIR sont destinés à être utilisés par tout le monde, indépendamment de la morphologie faciale ou de la capacité.

Naprave za preprečevanje respiratornih okužb za lastno zaščito in zaščito tretjih oseb - 2. del: Preskusne metode

General Information

• Status: Not Published
• Public Enquiry End Date: 24-Sep-2025
• ICS: 13.340.20 - Head protective equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 17-Jul-2025
• Due Date: 04-Dec-2025
• Completion Date: 29-Sep-2025
• Directive: Harmonized Standard2016/425 - Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC
• Directive:

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  Harmonized Standard2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Ref Project: prEN 18178-2 - Respiratory infection prevention devices for self- and third-party protection - Part 2: Test methods

Overview

oSIST prEN 18178-2:2025 is a draft standard published by the Slovenian Institute for Standardization (SIST) under the series "Respiratory infection prevention devices for self- and third-party protection." Part 2 of this series focuses on the test methods for evaluating respiratory infection prevention devices (RIPDs). These devices are designed to reduce the transmission of infectious agents both from the wearer to the environment and to the wearer from the environment, making them essential for infection control in various settings.

This standard aligns with European regulatory frameworks such as the Medical Device Regulation (EU) 2017/745 and the Personal Protective Equipment Regulation (EU) 2016/425. It is applicable to a wide range of users, regardless of facial morphology or ability, thus supporting universal protection.

Key Topics

oSIST prEN 18178-2:2025 describes comprehensive test methods to ensure the effectiveness, safety, and user compatibility of RIPDs. Key aspects covered include:

• Total inward leakage (TIL): Methods to assess the amount of airborne contaminants entering the device when worn.
• Total outward leakage (TOL): Procedures for measuring emission of particles from the wearer into the environment.
• Particle filter efficiency and bacterial filtration efficiency (BFE): Testing to evaluate how well a device filters particulates and bacteria.
• Work of breathing and breathing resistance: Ensuring devices are comfortable and safe for extended use.
• Carbon dioxide build-up: Assessment to mitigate risks of CO₂ accumulation inside the device.
• Biocompatibility and wearer safety: Evaluation of potential wearer injury, discomfort, and biocompatibility risks.
• Practical performance tests: Simulated real-world activities to verify the RIPD’s functional performance.
• Splash resistance, flame resistance, and microbial cleanliness: Additional safety evaluations to confirm suitability for various environments.

All test methods are defined to be reproducible and align with referenced international standards and established best practices for personal protective equipment and medical devices.

Applications

RIPDs tested in accordance with oSIST prEN 18178-2:2025 are applicable for a variety of practical uses, including:

• Healthcare environments: Protecting patients and healthcare workers by minimizing infection risks.
• Public settings: Enhancing infection control in crowded areas during outbreaks or pandemics.
• Occupational safety: Supporting employers’ obligations under health and safety regulations.
• Universal use: Suitability for people with different facial features, supporting inclusivity and compliance with accessibility requirements.
• Product development and certification: Providing manufacturers with reliable testing protocols, facilitating conformity assessment, and supporting market access across the EU.

By following these standardized test methods, manufacturers and authorities can ensure that RIPDs meet rigorous requirements for filtration efficiency, safety, and usability, ultimately safeguarding public health.

Related Standards

oSIST prEN 18178-2:2025 is part of a broader suite of standards and references frequently used in the field of respiratory protection:

• prEN 18178-1:2025 - Requirements and marking for RIPDs
• EN 14683:2025 - Medical face masks - Requirements and test methods
• EN ISO 16972:2020 - Respiratory protective devices - Vocabulary and graphical symbols
• ISO 16900 series - Methods of test and test equipment for respiratory protective devices (including leakage, breathing resistance, CO₂, flame resistance, and field of vision)
• EN ISO 10993-1:2020 - Biological evaluation of medical devices
• EN 13274-2:2019 - Practical performance tests for respiratory protective devices
• ISO 22609:2004 - Resistance of medical face masks to penetration by synthetic blood

Manufacturers, testing laboratories, and regulatory bodies should refer to these associated standards to ensure comprehensive compliance and optimal performance of respiratory infection prevention devices.

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Keywords: respiratory infection prevention devices, test methods, RIPD, total inward leakage, total outward leakage, filtration efficiency, biocompatibility, PPE standard, EN 18178-2, respiratory protection, safety testing, universal design, European standards

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2025
Naprave za preprečevanje respiratornih okužb za lastno zaščito in zaščito tretjih
oseb - 2. del: Preskusne metode
Respiratory infection prevention devices for self- and third-party protection - Part 2: Test
methods
Atemwegsinfektionsschutzgeräte für den Selbst- und Fremdschutz - Teil 2: Prüfverfahren
Dispositifs de prévention des infections respiratoires pour la protection individuelle et de
tiers - Partie 2 : Méthodes d’essai
Ta slovenski standard je istoveten z: prEN 18178-2
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 2: Test methods
Dispositifs de prévention des infections respiratoires Atemwegsinfektionsschutzgeräte für den Selbst- und
pour la protection individuelle et de tiers - Partie 2 : Fremdschutz - Teil 2: Prüfverfahren
Méthodes d'essai
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 18178-2:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms, definitions and abbreviations . 6
3.1 Terms and definitions . 6
3.2 Abbreviations . 6
4 Test methods . 6
4.1 General. 6
4.2 Total inward leakage (TIL) . 6
4.2.1 General. 6
4.2.2 Prerequisites . 7
4.2.3 Particle size . 7
4.3 Total outward leakage (TOL) . 7
4.3.1 Principle . 7
4.3.2 General requirements . 7
4.3.3 Procedure . 7
4.3.4 Determination of TOL . 8
4.4 Work of breathing and breathing resistance . 9
4.5 Bacterial filtration efficiency (BFE) . 9
4.6 Particle filter efficiency . 9
4.7 Carbon dioxide . 9
4.7.1 General. 9
4.7.2 Prerequisites . 9
4.8 Facial expression visibility . 10
4.9 Resistance to flame – Single burner dynamic . 10
4.10 Field of vision . 10
4.11 Microbial cleanliness (bioburden) . 10
4.12 Splash resistance . 10
4.13 Biocompatibility . 10
4.14 Wearer injury and discomfort. 10
4.15 Fixation to head and face . 10
4.16 Auditory interference. 10
4.17 Compatibility . 10
4.18 Fogging and dripping . 10
4.19 Practical performance tests . 11
Bibliography . 12

European foreword
This document (prEN 18178-2:2025) 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.
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 is intended to supplement prEN 18178-1:2025 for respiratory infection prevention
devices (RIPD).
The test methods are specified for complete systems or parts of devices.
The test methods listed are used to assess the requirements specified in prEN 18178-1:2025.
Specifications for the conduct of the test methods specified in this document are given in the
prEN 18178-1:2025.
NOTE Only Part 1 of this series of standards has been prepared under Standardization Request M/575.
1 Scope
This document specifies the test methods 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 regardless of facial morphology or ability.
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 18178-1:2025, Respiratory infection prevention devices for self- and third-party protection — Part 1:
Requirements and marking
EN 13274-2:2019, Respiratory protective devices — Methods of test — Part 2: Practical performance tests
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 ISO 11737-1:2018, Sterilization of health care products — Microbiological methods — Part 1:
Determination of a population of microorganisms on products (ISO 11737-1:2018)
EN ISO 10993-1:2020, Biological evaluation of medical devices — Part 1: Evaluation and testing within a
ris
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