oSIST prEN 18178-5:2025

SLOVENSKI STANDARD
01-december-2025
Naprave za preprečevanje respiratornih okužb za lastno zaščito in zaščito tretjih
oseb - 1. del: Klasifikacija
Respiratory infection prevention devices for self- and third-party protection - Part 5:
Classification
Atemwegsinfektionsschutzgeräte für den Selbst- und Fremdschutz - Teil 5: Klassifikation
Dispositifs de prévention des infections respiratoires pour la protection individuelle et de
tiers - Partie 5 : Classification
Ta slovenski standard je istoveten z: prEN 18178-5
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
October 2025
ICS 13.340.20
English Version
Respiratory infection prevention devices for self- and
third-party protection - Part 5: Classification
Dispositifs de prévention des infections respiratoires Atemwegsinfektionsschutzgeräte für den Selbst- und
pour la protection individuelle et de tiers - Partie 5 : Fremdschutz - Teil 5: Klassifikation
Classification
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 18178-5:2025 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 . 5
3.1 Terms and definitions . 5
3.2 Abbreviations . 6
4 Classification. 6
4.1 General. 6
4.2 Inward Protection Class (IPC) based on Total Inward Leakage (TIL) . 6
4.3 Outward Protection Class (OPC) based on Total Outward Leakage (TOL) . 6
4.4 Classification of Work Rate based on Respiratory Minute Volume . 6
4.5 Classification of Work of Breathing Classes . 7
4.6 Classification of Breathability . 7
4.7 Classification of Carbon Dioxide Limits . 7
4.8 Classification of Particle Filters . 8
4.9 RIPD Interface class . 8
5 Sequence of Filtering Infection Protective Device Classification . 9
6 RIPD-Types . 10
Bibliography . 11
European foreword
This document (prEN 18178-5:2025) 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.
EN 18178-5 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
The following parts are under development:
— Part 3: Sustainability, human factors and rationales
— Part 4: Selection and use
— Part 5: Classification
Introduction
Outbreaks of respiratory infection could require a device that is protective in both breathing directions
(outward and inward). In environments relating to the regulation (EU) 2017/745 on Medical Devices
(MD) the applicable standard is EN 14683. In environments relating to the regulation (EU) 2016/425 on
Personal Protective Equipment (PPE) there is a number of applicable standards (for example EN 149). In
environments where the two former EU regulations are not applicable, the General Product Safety
Directive (2001/95/EC) (GPSD) applies supported by CEN/TS 17553. This document intends to define
requirements for respiratory infection prevention devices that will be regulated under both MD 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 of EN 18178-1 might be used as a
respiratory infection prevention device (RIPD) and provides protection against infectious agents at the
level described in the classification.
Essential parts of the EN 18178 series are prEN 18178-1, prEN 18178-2 and prEN 18178-5.
In EN 18178-1 all requirements for a product to be considered as a RIPD are defined whereas the
corresponding test methods to each requirement can be found in prEN 18178-2.
This document defines the classification for a product to be considered as a RIPD.
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.

Under preparation.
Under preparation.
1 Scope
This document specifies the classification 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 1:
Requirements and markings
3 Terms, definitions and abbreviations
3.1 Terms and definitions
For the purposes of this document, the following terms and definitions 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
loose fitting device
respiratory interface that does not rely on forming a complete seal to the wearer’s skin
[SOURCE: EN ISO 16972:2020, 3.132 – modified RI was change to device in the term.]
3.1.2
respiratory infection protection device
RIPD
device intended to reduce the emission of infective agents from the use
...