EN 14031:2021

SLOVENSKI STANDARD
01-september-2021
Nadomešča:
SIST EN 14031:2003
Izpostavljenost na delovnem mestu - Kvantitativno določevanje lebdečih
endotoksinov
Workplace exposure - Quantitative measurement of airborne endotoxins
Exposition am Arbeitsplatz - Quantitative Messung von luftgetragenen Endotoxinen
Exposition sur les lieux de travail - Mesure quantitative des endotoxines aéroportées
Ta slovenski standard je istoveten z: EN 14031:2021
ICS:
13.040.30 Kakovost zraka na delovnem Workplace atmospheres
mestu
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 14031
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2021
EUROPÄISCHE NORM
ICS 13.040.30 Supersedes EN 14031:2003
English Version
Workplace exposure - Quantitative measurement of
airborne endotoxins
Exposition sur les lieux de travail - Mesure quantitative Exposition am Arbeitsplatz - Quantitative Messung von
des endotoxines aéroportées luftgetragenen Endotoxinen
This European Standard was approved by CEN on 7 June 2021.

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. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists 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, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14031:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Requirements . 6
4.1 Skills needed for sampling . 6
4.2 Sampling . 7
4.2.1 General . 7
4.2.2 Equipment . 7
4.2.3 Filters . 7
4.3 Sample transport . 7
4.4 Sample storage at the laboratory . 8
4.5 Glassware . 8
4.6 Extraction liquids, water and detergents . 8
4.7 Test for contamination . 8
4.8 Sampling documentation . 8
5 Extraction . 9
5.1 General . 9
5.2 Equipment . 9
5.3 Procedure. 9
5.4 Storage conditions . 10
5.5 Documentation of extraction . 10
6 Analytical method . 10
6.1 General . 10
6.2 Equipment . 11
6.3 Procedure. 11
6.3.1 Measurement . 11
6.3.2 Calibration . 11
6.3.3 Calculation . 11
6.4 Validation . 12
6.5 Documentation of analysis . 12
7 Expression of results . 12
8 Precision . 13
9 Test report . 13
Annex A (informative) Properties of endotoxins and sources of occupational exposure . 14
Annex B (informative) Principle of LAL-assays . 17
Annex C (informative) Deposition of endotoxins on inner sampler walls . 19
Bibliography . 20

European foreword
This document (EN 14031:2021) has been prepared by Technical Committee CEN/TC 137 “Assessment
of workplace exposure to chemical and biological agents”, the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2022, and conflicting national standards shall
be withdrawn at the latest by January 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 14031:2003.
The major technical changes between this document and the previous edition are as follows:
a) document title adjusted to the wording used in the Scope;
b) terms and definitions taken over from EN 13098:2019, where appropriate;
c) Clause 4 restructured;
d) requirements for sample storage at the laboratory rewritten;
e) recommendations for extraction of samples revised;
f) storage conditions described more precisely;
g) further requirements on documentation of extraction added;
h reference given to the recombinant Factor C (rFC) method as Note to 6.1;
i) new Table A.1 with examples on working areas with exposure to endotoxin added;
j) new Annex C on deposition of endotoxins on inner sampler walls added;
k) whole document editorially revised.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: 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, Turkey and the
United Kingdom.
Introduction
The term 'endotoxin' refers to lipopolysaccharides that are present in the outer membrane of the cell
walls of Gram-negative bacteria. These lipopolysaccharides are a class of pure lipid carbohydrate
molecules (free of protein and other cell wall components) that are held responsible for most of the
biological properties characteristic of bacterial endotoxins.
Endotoxins play an important role in the development of organic dust-related symptoms (for example,
inflammatory reactions in the airways and/or systemic reactions) among workers exposed via
inhalation.
To investigate ill health resulting from occupational exposure to airborne endotoxins it is important
therefore to measure their presence in workplace air accurately. At present, different methods are used
to measure airborne endotoxins. Standardization with respect to sampling, transportation, extraction,
analytical methods and storage of samples or extracts is important in order to obtain accurate and
comparable results and reduce uncertainties in exposure assessment.
1 Scope
This document specifies methods for the quantitative measurement of airborne endotoxins and gives
general requirements for sampling on filters, transportation, storage as well as the analysis of samples.
This document provides also guidelines for the assessment of workplace exposure to airborne
endotoxins.
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.
EN 481, Workplace atmospheres — Size fraction definitions for measurement of airborne particles
EN 1540, Workplace exposure — Terminology
EN ISO 13137, Workplace atmospheres — Pumps for personal sampling of chemical and biological agents
— Requirements and test methods (ISO 13137)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 1540 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at https://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
Note 1 to entry: In particular, the following terms used in this document are defined in EN 1540: aerosol,
biological agent, bioaerosol, exposure (by inhalation), inhalable fraction, measuring procedure, personal sampling,
static sampling and workplace.
3.1
control standard endotoxin
CSE
standard that is traceable to the reference standard endotoxin (RSE)
3.2
endotoxin
constituent of the external membrane of Gram-negative bacteria (lipopolysaccharide), consisting of a
complex lipid, lipid A, which is covalently bound to a polysaccharide
Note 1 to entry: “Free endotoxin” is liberated after cell death and by budding from living cells. Lipid A is the
active (toxic) part and is a potent pro-inflammatory substance and can induce febrile, bronchial and other
symptoms in exposed workers. The composition and the toxicity of endotoxin differ between bacteria species.
Note 2 to entry: A brief overview with respect to physical and chemical properties of endotoxins and sou
...