SIST EN 14583:2022
(Main)Workplace exposure - Volumetric bioaerosol samplers - General requirements and evaluation of performance
Workplace exposure - Volumetric bioaerosol samplers - General requirements and evaluation of performance
This document specifies general requirements for the use and evaluation of physical and biological performance of volumetric sampling devices applied for assessing bioaerosols in the workplace.
This document lists the criteria for the selection of microbial strains that can be used for the evaluation of biological performance of samplers.
This document also describes a bioaerosol test chamber suited for assessing the biological performance of bioaerosol sampling devices.
This document is not applicable for clean room measurements.
Exposition am Arbeitsplatz - Volumetrische Sammler für Bioaerosole - Allgemeine Anforderungen und Bewertung der Leistungsfähigkeit
Dieses Dokument legt allgemeine Anforderungen an die Bewertung von volumetrischen Sammlern für Bioaerosole fest, um die Exposition am Arbeitsplatz sowie deren physikalische und biologische Leistungs-fähigkeit zu beurteilen.
Dieses Dokument beschreibt die Verfahren zur Entwicklung von volumetrischen Sammlern für Bioaerosole sowie deren Eigenschaften und Validierung.
Dieses Dokument enthält eine Beschreibung einer Prüfeinrichtung sowie Auswahlkriterien für Stämme von Mikroorganismen, die zur Bewertung von deren biologischer Leistungsfähigkeit verwendet werden können.
Dieses Dokument richtet sich an Hersteller und Entwickler von volumetrischen Sammlern für Bioaerosole sowie an Prüfeinrichtungen, die über die Ausrüstung und Befähigung verfügen, Leistungsmessungen dieser Sammler durchzuführen (siehe Anhang D für Anwendungshinweise).
Dieses Dokument ist nicht für Betreiber bestimmt, die volumetrische Sammler für Bioaerosole verwenden, um Expositionsmessungen von Arbeitnehmern an Arbeitsplätzen durchzuführen.
Exposition sur les lieux de travail - Dispositifs de prélèvement volumétrique des bioaérosols - Exigences générales et évaluation des performances
Le présent document spécifie des exigences générales relatives à l’évaluation des dispositifs de prélèvement volumétrique des bioaérosols visant à déterminer l’exposition sur les lieux de travail ainsi qu’à l’évaluation de leurs performances physiques et biologiques.
Le présent document décrit les modes opératoires pour le développement des dispositifs de prélèvement volumétrique des bioaérosols ainsi que leurs caractéristiques et le processus de validation.
Le présent document décrit une installation d’essai ainsi que les critères de sélection des souches microbiennes pouvant être utilisées pour l’évaluation des performances biologiques des dispositifs.
Le présent document couvre les exigences à l’attention des fabricants et développeurs de dispositifs de prélèvement volumétrique des bioaérosols ainsi que celles relatives aux installations d’essai disposant des équipements et des compétences pour mesurer les performances de ces dispositifs (voir l’Annexe D pour consulter les recommandations d’application).
Le présent document n’est pas destiné aux opérateurs utilisant des dispositifs de prélèvement volumétrique des bioaérosols pour mesurer l’exposition des travailleurs sur leurs lieux de travail.
Le présent document ne s’applique pas aux mesurages en salle propre, sauf dans le cadre de la sécurité au travail.
Izpostavljenost na delovnem mestu - Vzorčevalniki za volumetrijsko vzorčenje bioaerosolov - Splošne zahteve in vrednotenje lastnosti
Ta dokument določa splošne zahteve za uporabo ter vrednotenje fizičnih in bioloških lastnosti naprav za volumetrično vzorčenje, ki se uporabljajo za ocenjevanje bioaerosolov na delovnem mestu.
Ta dokument navaja merila za izbiro mikrobnih sevov, ki se lahko uporabijo za oceno bioloških lastnosti vzorčevalnikov.
Ta dokument opisuje tudi preskusno komoro za bioaerosol, primerno za ocenjevanje bioloških lastnosti naprav za vzorčenje bioaerosolov.
Dokument se ne uporablja za meritve čistih prostorov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 14583:2022
01-marec-2022
Nadomešča:
SIST EN 14583:2004
Izpostavljenost na delovnem mestu - Vzorčevalniki za volumetrijsko vzorčenje
bioaerosolov - Splošne zahteve in vrednotenje lastnosti
Workplace exposure - Volumetric bioaerosol samplers - General requirements and
evaluation of performance
Exposition am Arbeitsplatz - Volumetrische Sammler für Bioaerosole - Allgemeine
Anforderungen und Bewertung der Leistungsfähigkeit
Exposition sur les lieux de travail - Dispositifs de prélèvement volumétrique des
bioaérosols - Exigences générales et évaluation des performances
Ta slovenski standard je istoveten z: EN 14583:2021
ICS:
13.040.30 Kakovost zraka na delovnem Workplace atmospheres
mestu
SIST EN 14583:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 14583:2022
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SIST EN 14583:2022
EN 14583
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2021
EUROPÄISCHE NORM
ICS 13.040.30 Supersedes EN 14583:2004
English Version
Workplace exposure - Volumetric bioaerosol samplers -
General requirements and evaluation of performance
Exposition sur les lieux de travail - Dispositifs de Exposition am Arbeitsplatz - Volumetrische Sammler
prélèvement volumétrique des bioaérosols - Exigences für Bioaerosole - Allgemeine Anforderungen und
générales et évaluation des performances Bewertung der Leistungsfähigkeit
This European Standard was approved by CEN on 8 November 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 14583:2021 E
worldwide for CEN national Members.
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SIST EN 14583:2022
EN 14583:2021 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Abbreviated terms . 7
5 Requirements for volumetric bioaerosol samplers . 7
5.1 General . 7
5.2 Use in potentially explosive atmospheres . 8
5.3 Mechanical construction . 8
5.4 Indicator devices . 8
5.5 Adjustments . 8
5.6 Battery powered samplers . 8
5.7 Airflow calibration and control . 8
5.8 Airflow meter . 8
5.9 Labelling and marking . 8
5.10 Instruction handbook . 9
5.11 Sampling efficiency . 9
5.11.1 General . 9
5.11.2 Physical sampling efficiency . 9
5.11.3 Biological preservation efficiency . 9
5.12 Functional range of concentration . 9
5.13 Loading of the sampler . 9
5.14 Cleaning of the sampler . 10
5.15 Additional requirements . 10
6 Requirements for testing of biological preservation efficiency of volumetric
bioaerosol samplers . 10
6.1 General . 10
6.2 Test facility . 10
6.3 Test particles . 10
6.3.1 Concentration range . 10
6.3.2 Production of test bioaerosol . 10
6.4 Environmental conditions . 11
6.4.1 General . 11
6.4.2 Temperature . 11
6.4.3 Relative humidity . 11
6.4.4 Experimental conditions for measuring the physical sampling efficiency of
bioaerosol samplers . 11
6.5 Stabilization time . 11
6.6 Orientation . 11
6.7 Airflow of test facility. 12
7 Test report . 12
Annex A (informative) Bioaerosol sampling . 13
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SIST EN 14583:2022
EN 14583:2021 (E)
Annex B (normative) Test facilities usable for assessing biological performance of
volumetric bioaerosol samplers . 15
Annex C (informative) Microbial model organisms used for bioaerosol studies . 19
Annex D (informative) Application guidance . 21
Bibliography . 22
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SIST EN 14583:2022
EN 14583:2021 (E)
European foreword
This document (EN 14583:2021) 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 June 2022, and conflicting national standards shall be
withdrawn at the latest by June 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 14583:2004.
The major technical changes between this document and the previous edition are as follows:
a) document title changed;
b) Scope rewritten and given more detailed;
c) Terms and definitions already referred to in EN 1540 or EN 13098 deleted;
d) Annex B revised by replacing the former content by general requirements on test facilities and an
overview on different types and examples of test facilities;
e) new Annex C on microbial model organisms used for bioaerosol studies added;
f) new Annex D giving application guidance added;
g) Bibliography updated;
h) whole document restructured, editorially and technically 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.
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SIST EN 14583:2022
EN 14583:2021 (E)
Introduction
This document is needed to promote the development of new equipment for measurement of
microorganisms in the work environment. This document can also apply to existing equipment. It is
intended to specify requirements and methods to determine performance characteristics of volumetric
bioaerosol samplers used to collect bioaerosols from the workplace atmosphere. Examples of test
facilities and microbial model organisms usually used for laboratory measurements of the biological
preservation efficiency of volumetric bioaerosol samplers are provided.
WARNING — The use of this document can involve hazardous materials, operations and
equipment. This document does not purport to address all of the safety problems associated with
its use. It is the responsibility of the user of this document to take appropriate health and safety
precautions and to check which restrictive rules and regulations need to be taken into account
prior to use.
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SIST EN 14583:2022
EN 14583:2021 (E)
1 Scope
This document specifies general requirements for the evaluation of volumetric bioaerosol samplers in
order to assess workplace exposure and their physical and biological performance.
This document describes the procedures for the development of volumetric bioaerosol samplers as well
as their properties and validation.
This document provides a description of a test facility and selection criteria for microbial strains that can
be used to assess their biological performance.
This document addresses requirements to manufacturers and developers of volumetric bioaerosol
samplers as well as to test facilities with the equipment and skills to carry out the performance
measurements of these samplers (see Annex D for application guidance).
This document is not intended for operators who use volumetric bioaerosol samplers to carry out
exposure measurements for workers at occupational settings.
This document is not applicable for clean room measurements other than for occupational safety.
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 1540, Workplace exposure - Terminology
EN 13098:2019, Workplace exposure - Measurement of airborne microorganisms and microbial
compounds - General requirements
EN 60079-1, Explosive atmospheres - Part 1: Equipment protection by flameproof enclosures "d"
EN 60079-2, Explosive atmospheres - Part 2: Equipment protection by pressurized enclosure "p"
EN 60079-5, Explosive atmospheres - Part 5: Equipment protection by powder filling "q"
EN 60079-6, Explosive atmospheres - Part 6: Equipment protection by liquid immersion "o"
EN 60079-7, Explosive atmospheres - Part 7: Equipment protection by increased safety "e"
EN 60079-11, Explosive atmospheres - Part 11: Equipment protection by intrinsic safety “i”
EN 60079-18, Explosive atmospheres - Part 18: Equipment protection by encapsulation "m"
EN 60079-25, Explosive atmospheres - Part 25: Intrinsically safe electrical systems
EN IEC 60079-0, Explosive atmospheres - Part 0: Equipment - General requirements (IEC 60079-0)
EN ISO 13137, Workplace atmospheres - Pumps for personal sampling of chemical and biological agents -
Requirements and test methods (ISO 13137)
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SIST EN 14583:2022
EN 14583:2021 (E)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 1540, EN 13098 and the
following apply.
ISO and IEC maintain terminological 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
personal sampler
sampler, attached to a person, that collects gases, vapours or airborne particles in the breathing zone for
the purpose of measuring exposure to chemical agents and/or biological agents
Note 1 to entry: Some samplers have integral pumps, and some do not. Where the personal sampler requires the
use of an external pump, the pump is not subject to the requirements of this document.
[SOURCE: ISO 18158:2016, 2.2.2.2, modified – Note 1 to entry has been added.]
3.2
particle aerodynamic diameter
3
diameter of a sphere of 1 g/cm density with the same terminal settling velocity in calm air as the particle,
under the prevailing conditions of temperature, pressure and relative humidity
[SOURCE: ISO 18158:2016, 2.1.4.8, [21]]
4 Abbreviated terms
ATCC American Type Culture Collection
CBS Centraalbureau voor Schimmelcultures
CCUG Culture Collection University of Göteborg
DSMZ Deutsche Stammsammlung für Mikroorganismen und Zellkulturen
HEPA High Efficiency Particulate Air-(filter)
NCTC National Collection of Type Cultures
OPC Optical Particle Counter
5 Requirements for volumetric bioaerosol samplers
5.1 General
The pumps used for personal sampling shall fulfil the requirements specified in EN ISO 13137.
NOTE EN 13205 can be used to assess the sampler performance for measurement of airborne particle
concentrations. However, at present no practical experience is reported on the application of EN 13205 for
volumetric bioaerosol samplers.
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SIST EN 14583:2022
EN 14583:2021 (E)
5.2 Use in potentially explosive atmospheres
When the sampler covered by this document is to be used in potentially explosive atmospheres, it shall
comply with EN IEC 60079-0, EN 60079-1, EN 60079-2, EN 60079-5, EN 60079-6, EN 60079-7,
EN 60079-11, EN 60079-18 and EN 60079-25.
5.3 Mechanical construction
Every sampler shall be constructed in such a manner that it is easily accessible for regular function checks
and that airflow can easily be measured and calibrated. The sampling pump shall maintain the required
airflow rate throughout the sampling period.
Material used in the sampling head should be chosen to avoid moisture uptake and electrostatic charges.
5.4 Indicator devices
An indicator device shall be provided to show that the sampler is switched on. If the sampler has more
than one measuring range, the selected range shall be clearly identified.
NOTE It is an advantage if elapsed time indicators, low flow rate indicators, flow interrupted indicators are
given.
5.5 Adjustments
Any equipment (switch, knob, etc.) used for modifying the operating parameters (sampling time, flow
rate, etc.) of the sampler shall be protected against inadvertent or purposeful adjustment during
sampling. The operational settings should be displayed.
5.6 Battery powered samplers
Samplers powered with integrated batteries shall be provided with an early indication of low battery
condition.
5.7 Airflow calibration and control
During sampling the deviation from the required airflow should not exceed ± 5 %.
The manufacturer shall state the following:
a) the way in which the calibration of the air flow rate of the sampler can be checked and re-calibration
can be done, if necessary;
b) the parameters that should be calibrated, the frequency required and whether the calibration can be
carried out by the operator.
5.8 Airflow meter
A device to measure the airflow through the sampler before and after sampling in the field should be
supplied if required.
NOTE This device can be different from that used for calibration.
Samplers with integral airflow meters shall be calibrated against a traceable external airflow meter
before use.
5.9 Labelling and marking
The manufacturer of the sampler shall be clearly identified to ensure traceability to specified
performance characteristics.
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SIST EN 14583:2022
EN 14583:2021 (E)
5.10 Instruction handbook
The instruction handbook shall be written in a language, which is understandable in the country of the
operator. It shall be easily understood and every function explained.
The instruction handbook shall illustrate all components and their handling by figures.
The instruction handbook shall give the environmental conditions and other conditions under which the
sampler shall be operated including limitations to its use. It shall give exact calibration instructions and
recommended equipment (e.g. flow meters) to be used. The instruction handbook shall also give
instructions for troubleshooting and maintenance of the sampler.
5.11 Sampling efficiency
5.11.1 General
The sampling efficiency of samplers collecting biological agents comprises of a physical part, the physical
sampling efficiency (see 5.11.2) and the biological preservation efficiency (see 5.11.3).
The sampler should be able to collect a representative sample of the required health-related fraction of
the bioaerosol according to EN 481.
The health-related fraction to be used shall be specified by the manufacturer.
5.11.2 Physical sampling efficiency
The physical sampling efficiency can be measured as a function of particle aerodynamic diameter and
other influent parameters. For bioaerosol samplers the physical sampling efficiency which corresponds
to the (size-selective) sampling efficiency should comply with EN 13205, where applicable.
When assessing the performance of any bioaerosol sampler, the overall sampling efficiency (see A.2,
item c)) shall be determined.
The performance of a personal sampler is affected by the proximity of the operator's body when worn
within the breathing zone. This needs to be taken into account when assessing that performance. See A.2.
NOTE Annex A gives some information about the physical behaviour of a sampler and the experimental
assessment of its physical sampling efficiency in the laboratory.
5.11.3 Biological preservation efficiency
To determine the culturable number of microorganisms, the sampler shall be tested with relevant
microorganisms to establish the biological preservation efficiency. The ability of the sampling medium to
maintain the integrity of the sampled microorganisms shall be known.
5.12 Functional range of concentration
The manufacturer shall give the upper and lower functional range for the concentration of collected
culturable microorganisms and/or the total number of microorganisms.
The manufacturer shall specify the maximum sampling time or the sampling volume that can be sampled
without recharging battery-operated samplers or replacing the collection substrate.
NOTE The sampling time can vary from a few minutes up to an 8 h workshift.
5.13 Loading of the sampler
The sampler shall be loaded, emptied and reloaded easily with aseptic collection substrates at the
workplace with a minimum loss of collected bioaerosol.
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EN 14583:2021 (E)
5.14 Cleaning of the sampler
The sampler shall be constructed in such a way that cleaning and decontamination in the field can be
done easily and disinfection in the laboratory is possible.
If required for biosecurity or contamination control purposes, samplers shall be resistant to
decontamination by surface disinfection or fumigation, e.g. by using hydrogen peroxide vapour.
5.15 Additional requirements
When possible, battery-operated samplers should have a short recharge time.
All samplers should be light-weighted and have low noise levels.
6 Requirements for testing of biological preservation efficiency of volumetric
bioaerosol samplers
6.1 General
The test conditions applied shall be within the operational range of the sampler as specified by the
manufacturer.
The risk class to which the microbial model organisms belong to shall be compatible with the level of
safety of the test facility and the training of the operators so that microbial model organisms are handled
under optimum safety and health protection conditions.
For the purpose of testing the performance of samplers, the tests shall be carried out on at least two
replicate samplers and compared to the performance of a reference sampler.
The biological preservation efficiency itself cannot be determined as the actual concentration cannot be
measured without any bias. In practise, bioaerosol samplers are compared to each other to show
differences with regard to their biological preservation efficiency.
6.2 Test facility
The biological performance of the bioaerosol samplers shall be studied in a test facility into which specific
aerosols of microorganisms can be generated in suitable conditions (see Annex B). The ratio between the
concentration of microorganisms measured by the sampler to be tested and the concentration assessed
by the reference sampler shall be calculated by using representative microorganisms (see Annex C).
The reference sampler shall comply with the requirements given in EN 13098:2019, 6.2.2.
6.3 Test particles
6.3.1 Concentration range
The test environment shall consist of single particles as well as aggregates of particles in an atmosphere
with controllable relative humidity and temperature. The concentration range of particles within which
the sampler is evaluated shall be given. The temperature and relative humidity of the test environment
shall be stated.
Restrictions on the usability of the sampler in terms of temperature and relative humidity shall be
specified by the manufacturer.
6.3.2 Production of test bioaerosol
Microbial cell suspensions shall be controllably aerosolised and homogeneously mixed in a test facility at
selected temperature and relative humidity. The particle size shall be specified.
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EN 14583:2021 (E)
The microbial model organisms (see Annex C) and media used for their growth shall be specified and
should be appropriate to the end use of the sampler. The microbial strains shall be available from a
standard culture collection (i.e. ATCC, CCUG, NCTC, CBS, DSMZ).
NOTE Microbial model organisms can be cultivated in liquid, solid or semisolid culture media. The bioaerosol
can be generated from water or selected buffer solutions. This can change the surface characteristics of the
bioaerosol particles. Spore aerosols can also be generated from dust or powder. See references [8] to [11].
6.4 Environmental conditions
6.4.1 General
Samplers need to perform optimally in typical ambient environmental conditions. Tests therefore shall
be carried out to determine the impact of variations in air temperature, air pressure, and relative
humidity conditions on flow rate and sampled air volume.
The tests shall be performed inside a test facility, with controlled temperature and relative humidity. A
separate enclosure can be needed for the tests with a variable air pressure. Sufficient replicates of each
combination of temperature and relative humidity conditions used shall be tested to determine statistical
significance. The environmental conditions shall be monitored during sampling time. The mean of each
measured variable and its standard deviation shall be calculated. The results of the tests shall be given in
the test report and the operating conditions shall be documented.
6.4.2 Temperature
The tests shall be carried out at specified temperatures. At least two different conditions of temperature
(for example, about 10 °C and 25 °C) shall be used to cover the range as expected to be used by the
sampler.
6.4.3 Relative humidity
The tests shall be carried out at least at two different conditions of relative humidity (for example, at
about 20 %, 50 % and 80 %, if achievable) for each temperature used in 6.4.2.
6.4.4 Experimental conditions for measuring the physical sampling efficiency of bioaerosol
samplers
The experimental conditions for measuring the physical sampling efficiency of bioaerosol samplers
should be the same as those that are described in EN 13205. However, when bioaerosol samplers are only
designed to measure microorganisms and not microbial compounds, the calculation of uncertainty (of
measurement) relative to mass concentration is not required.
6.5 Stabilization time
For the purposes of the tests in each instance where the sampler is subjected to different test conditions,
the sampler shall be allowed to stabilize.
Maximum time for stabilization should not exceed 30 min.
6.6 Orientation
The manufacturer shall state in which orientations the sampling heads or inlets have been tested relative
to the bioaerosol air-stream and the test environment used (e.g. wind tunnel or test chamber). The
personal samplers shall be tested on a manikin.
When testing samplers in a wind tunnel, they should be tested in the test environment within the
orientation limits stated in the manufacturer's instruction manua
...
SLOVENSKI STANDARD
oSIST prEN 14583:2020
01-september-2020
Izpostavljenost na delovnem mestu - Naprave za volumetrijsko vzorčenje
bioaerosolov - Splošne zahteve za uporabo in vrednotenje lastnosti
Workplace exposure - Volumetric bioaerosol sampling devices - General requirements
for use and evaluation of performance
Exposition am Arbeitsplatz - Volumetrische Probenahmeeinrichtungen für Bioaerosole -
Allgemeine Anforderungen an die Verwendung und Evaluierung der Leistungsfähigkeit
Ta slovenski standard je istoveten z: prEN 14583
ICS:
13.040.30 Kakovost zraka na delovnem Workplace atmospheres
mestu
oSIST prEN 14583:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 14583:2020
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oSIST prEN 14583:2020
DRAFT
EUROPEAN STANDARD
prEN 14583
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2020
ICS 13.040.30 Will supersede EN 14583:2004
English Version
Workplace exposure - Volumetric bioaerosol sampling
devices - General requirements for use and evaluation of
performance
Exposition am Arbeitsplatz - Volumetrische
Probenahmeeinrichtungen für Bioaerosole -
Allgemeine Anforderungen an die Verwendung und
Evaluierung der Leistungsfähigkeit
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 137.
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, Turkey 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 14583:2020 E
worldwide for CEN national Members.
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oSIST prEN 14583:2020
prEN 14583:2020 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Abbreviated terms . 8
5 Requirements for sampling devices . 8
5.1 General . 8
5.2 Use in potentially explosive atmospheres . 8
5.3 Mechanical construction . 8
5.4 Indicator devices . 8
5.5 Adjustments . 9
5.6 Battery powered sampling devices . 9
5.7 Airflow control . 9
5.8 Airflow meter . 9
5.9 Labelling and marking . 9
5.10 Instruction handbook . 9
5.11 Fraction to be sampled . 9
5.12 Physical sampling efficiency . 10
5.13 Biological preservation efficiency . 10
5.14 Operational range of concentration . 10
5.15 Loading of the sampling device . 10
5.16 Cleaning of the sampling device. 10
5.17 Accuracy . 10
5.18 Additional requirements . 10
6 Testing of sampling devices . 11
6.1 General . 11
6.2 Test facility . 11
6.3 Test particles . 11
6.4 Environmental conditions . 12
6.5 Reference sampling device . 12
6.6 Stabilization time . 12
6.7 Orientation . 13
6.8 Calibration . 13
6.9 Air flow . 13
7 Test report . 13
Annex A (informative) Bioaerosol sampling . 14
A.1 General . 14
A.2 Aerodynamic behaviour of bioaerosol sampling devices. 14
A.3 Biological assays . 15
Annex B (normative) Test facilities usable for assessing biological performance of
bioaerosol sampling devices . 16
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B.1 General requirements . 16
B.2 Types of test facilities . 17
B.2.1 Components of a bioaerosol test facility . 17
B.2.2 Examples of bioaerosol test facilities . 18
Annex C (informative) Microbial model organisms used for bioaerosol studies . 20
Bibliography . 22
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European foreword
This document (prEN 14583:2020) 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 document is currently submitted to the CEN Enquiry.
This document will supersede EN 14583:2004.
The major technical changes between this document and the previous edition are as follows:
a) document title changed;
b) Scope rewritten and given more detailed;
c) Terms and definitions already referred to in EN 1540 or EN 13098 deleted;
d) Annex B revised by replacing the former content by general requirements on test facilities and an
overview on different types and examples of test facilities;
e) new Annex C on microbial surrogates used for bioaerosol studies added;
f) Bibliography updated;
g) whole document restructured and editorially and technically revised.
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Introduction
This document is needed to promote the development of new equipment for measurement of
microorganisms in the work environment. This document can also apply to existing equipment. It is
intended to specify requirements and methods to determine performance characteristics of sampling
devices used to collect bioaerosols from the workplace atmosphere. Examples of test environments and
methods will be described and test methods will be provided.
WARNING — The use of this document can involve hazardous materials, operations and equipment.
This document does not purport to address all of the safety problems associated with its use. It is the
responsibility of the user of this document to establish appropriate safety and health practices and to
determine the applicability of regulatory limitations prior to use.
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1 Scope
This document specifies general requirements for the use and evaluation of physical and biological
performance of volumetric sampling devices applied for assessing bioaerosols in the workplace.
This document lists the criteria for the selection of microbial strains that can be used for the evaluation
of biological performance of samplers.
This document also describes a bioaerosol test facility suited for assessing the biological performance of
bioaerosol sampling devices.
This document is not applicable for clean room measurements.
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 1540, Workplace exposure - Terminology
EN 13098, Workplace exposure - Measurement of airborne microorganisms and microbial compounds -
General requirements
EN 13205 (all parts), Workplace exposure - Assessment of sampler performance for measurement of
airborne particle concentrations
EN 60079-1, Explosive atmospheres - Part 1: Equipment protection by flameproof enclosures "d"
EN 60079-2, Explosive atmospheres - Part 2: Equipment protection by pressurized enclosure "p"
EN 60079-5, Explosive atmospheres - Part 5: Equipment protection by powder filling "q"
EN 60079-6, Explosive atmospheres - Part 6: Equipment protection by liquid immersion "o"
EN 60079-7, Explosive atmospheres - Part 7: Equipment protection by increased safety "e"
EN 60079-11, Explosive atmospheres - Part 11: Equipment protection by intrinsic safety "i"
EN 60079-18, Explosive atmospheres - Part 18: Equipment protection by encapsulation "m"
EN 60079-25, Explosive atmospheres - Part 25: Intrinsically safe electrical systems
EN ISO 13137, Workplace atmospheres - Pumps for personal sampling of chemical and biological agents -
Requirements and test methods (ISO 13137)
EN IEC 60079-0, Explosive atmospheres - Part 0: Equipment - General requirements (IEC 60079-0)
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3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 1540, EN 13098 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1
accuracy
closeness of agreement between a test result or measurement result and the true value
Note 1 to entry: In practise, the accepted reference value is substituted for the true value.
Note 2 to entry: The term “accuracy”, when applied to a set of test or measurement results, involves a
combination of random components and a common systematic error or bias component.
Note 3 to entry: Accuracy refers to a combination of trueness and precision.
Note 4 to entry: The quantity referred to in this document as accuracy provides an estimation of the range
around the measured value in which can be found the accepted reference value with the confidence of 95 %.
[SOURCE: ISO 3534-2:2006, 3.3.1, modified – All cross references have been removed and Note 4 to
entry has been added.]
3.2
bias
measurement bias
difference between the expectation of a test result or measurement result and a true value
Note 1 to entry: Bias is the total non-random error as contrasted to random error. There can be one or more
non-random error components contributing to the bias. A larger systematic difference from the true value is
reflected by a larger bias value.
Note 2 to entry: In practice, the accepted reference value is substituted for the true value. The accepted
reference value (for definition see ISO 3534-2) can be, for example, the certified value of a reference material, the
concentration of a standard test atmosphere or the target value of an interlaboratory comparison.
[SOURCE: ISO 3534-2:2006, 3.3.2, modified – Synonymous term “measurement bias” has been added.]
3.3
personal sampler
sampler, attached to a person, that collects gases, vapours or airborne particles in the breathing zone
for the purpose of measuring exposure to chemical agents and/or biological agents
Note 1 to entry: Some sampling devices have integral pumps, and some do not. Where the personal sampler
requires the use of an external pump, the pump is not subject to the requirements of this document.
[SOURCE: ISO 18158:2016, 2.2.2.2, modified – Note 1 to entry has been added.]
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3.4
particle aerodynamic diameter
3
diameter of a sphere of 1 g/cm density with the same terminal settling velocity in calm air as the
particle, under the prevailing conditions of temperature, pressure and relative humidity
[SOURCE ISO 18158:2016, 2.1.4.8]
3.5
sampling device
total equipment used for sampling, e. g. pump, sampling head and sampling substrate
4 Abbreviated terms
ATCC American Type Culture Collection
CBS Centraalbureau voor Schimmelcultures
CCUG Culture Collection University of Göteborg
DSMZ Deutsche Stammsammlung für Mikroorganismen und Zellkulturen
HEPA high efficiency particulate aerosol
NCTC National Collection of Type Cultures
RH relative humidity
T temperature
5 Requirements for sampling devices
5.1 General
The pumps used for personal sampling shall fulfil the requirements specified in EN ISO 13137.
5.2 Use in potentially explosive atmospheres
When the sampling device covered by this document is to be used in potentially explosive atmospheres,
it shall comply with EN IEC 60079-0, EN 60079-1, EN 60079-2, EN 60079-5, EN 60079-6, EN 60079-7,
EN 60079-11, EN 60079-18 and EN 60079-25.
5.3 Mechanical construction
Every sampling device shall be constructed in such a manner that it is easily accessible for regular
function checks and that airflow can easily be measured and calibrated. The sampling pump shall
maintain the required airflow rate throughout the sampling period.
Material used in the sampling head should be chosen to avoid moisture uptake and electrostatic
charges.
5.4 Indicator devices
An indicator device shall be provided to show that the sampling device is switched on. If the sampling
device has more than one measuring range, the selected range shall be clearly identified.
NOTE It is an advantage if elapsed time indicators, low flow rate indicators, flow interrupted indicators are
given.
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5.5 Adjustments
Any equipment (switch, knob, etc.) used for modifying the operating parameters (sampling time, flow
rate, etc.) of the sampling device shall be protected against inadvertent or purposeful adjustment during
sampling. The operational settings should be displayed.
5.6 Battery powered sampling devices
Sampling devices powered with integrated batteries shall be provided with an early indication of low
battery condition.
5.7 Airflow control
During the sampling deviation from the required airflow should not exceed ± 5 %.
5.8 Airflow meter
A device to measure the airflow through the sampling device before and after sampling in the field
should be supplied if required.
NOTE This device can be different from that used for calibration.
Sampling devices with integral airflow meters shall be calibrated against a traceable external airflow
meter before use.
5.9 Labelling and marking
The manufacturer of the sampling device shall be clearly identified to ensure traceability to specified
performance characteristics.
5.10 Instruction handbook
The instruction handbook shall be written in a language, which is understandable in the country of the
operator. It shall be easily understood and every function explained.
The instruction handbook shall illustrate all components and their handling by figures.
The instruction handbook shall give the environmental conditions and other conditions under which
the sampling device shall be operated including limitations to its use. It shall give exact calibration
instructions and recommended equipment (e.g. flow meters) to be used. The instruction handbook shall
also give instructions for troubleshooting and maintenance of the sampling device.
5.11 Fraction to be sampled
The sampling device should be able to collect a representative sample of the required health-related
fraction of the bioaerosol according to EN 481.
NOTE Most personal samplers collect the inhalable fraction of bioaerosol, but other samplers might be used
to collect the thoracic or respirable fraction as well.
For static sampling the health-related fraction to be used shall be specified by the manufacturer.
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5.12 Physical sampling efficiency
The physical sampling efficiency shall be measured as a function of particle aerodynamic diameter and
other influent parameters.
NOTE Annex A gives some information about the physical behaviour of a sampling device and the
experimental assessment of its physical sampling efficiency in the laboratory.
When assessing the performance of any bioaerosol sampling device, the total sampling efficiency shall
be determined.
The performance of a personal sampler will be affected by the proximity of the operator's body when
worn within the breathing zone, and therefore inhalable samplers for personal sampling shall be
assessed whilst attached to a torso or other well characterized equivalents.
5.13 Biological preservation efficiency
To determine the culturable number of microorganisms, the sampling device shall be tested with
relevant microorganisms to establish the biological preservation efficiency. The ability of sampling
medium to maintain the integrity of the sampled organisms shall be known.
5.14 Operational range of concentration
The manufacturer shall give the upper and lower operational range for the concentration of collected
culturable microorganisms and/or the total number of microorganisms.
The manufacturer shall specify the maximum sampling time or the sampling volume that can be
sampled without recharging battery-operated sampling devices or replacing the collection substrate.
The collected bioaerosol samples should refer to a time period representative of that corresponding to
the exposure pattern.
NOTE The sampling time can vary from a few minutes up to an 8 h workshift. Overloading can affect the
analysis negatively.
5.15 Loading of the sampling device
The sampling device shall easily be loaded aseptically, emptied and reloaded with new collection
substrates at the workplace with a minimum loss of collected bioaerosol.
5.16 Cleaning of the sampling device
The sampling device shall be constructed in such a way that cleaning and decontamination in the field
can be done easily and disinfection in the laboratory is possible.
If required for biosecurity or contamination control purposes, sampling devices shall be compatible
with decontamination by surface disinfection or fumigation, e.g. using hydrogen peroxide vapour.
5.17 Accuracy
Bias and accuracy shall be determined according to EN 13205-1 and refer on the health-related fraction
of the bioaerosol actually sampled (i.e. inhalable, thoracic or respirable fraction).
5.18 Additional requirements
When possible, battery-operated samplers should have a short recharge time.
All sampling devices should be light-weight and have low noise levels.
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6 Testing of sampling devices
6.1 General
The test conditions applied shall be within the operational range of the sampling device as specified by
the manufacturer.
The risk class to which the test microorganisms belong to shall be compatible with the level of safety of
the installations and the training of the operators so that surrogates are handled under optimum safety
and health conditions.
NOTE For the assessment of sampler performance for measurement of airborne particle concentrations, see
EN 13205.
For the purpose of testing the performance of sampling devices, the tests shall be carried out on at least
two replicate sampling devices and compared to the performance of a reference sampling device.
6.2 Test facility
The biological performance of the bioaerosol sampling devices shall be studied in a test facility into
which specified aerosols of microorganisms can be generated in suitable conditions (see Annex B). The
ratio between the concentration of microorganisms measured by the sampling device to be tested and
the concentration assessed by some reference sampler shall be calculated by using representative
microorganisms (see Annex C).
6.3 Test particles
6.3.1 Concentration range
The test environment shall consist of single particles as well as aggregates of particles in an atmosphere
with controllable relative humidity and temperature. The concentration range of particles within which
the sampling device is suitable shall be given. The temperature and relative humidity of the test
environment shall be stated.
Limitations in temperature and relative humidity for the sampling device shall be given by the
manufacturer.
6.3.2 Production of test bioaerosol
Microbial cell suspensions shall be controllably aerosolised and homogeneously mixed in a test facility
at selected temperature and relative humidity. The particle size shall be specified.
The test organisms (see Annex C) and media used for their growth shall be specified and should be
appropriate to the end use of the sampling device. The test strains shall be available from a standard
culture collection (i.e. ATCC, CCUG, NCTC, CBS, DSMZ).
NOTE Test bioaerosols can be produced from cultivations in liquid or semisolid culture media, water, or from
selected buffer solutions. This can change the surface characteristics of the bioaerosol particles. Spore aerosols
can also be generated from dust or powder.
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6.4 Environmental conditions
6.4.1 General
Sampling devices need to perform optimally in typical ambient environmental conditions. Tests
therefore shall be carried out to determine the impact of variations in air temperature, air pressure, and
relative humidity conditions on flow rate and sampled air volume.
The tests shall be performed inside a test facility, with controlled temperature and relative humidity. A
separate enclosure can be needed for the tests with a variable air pressure. Sufficient replicates of each
combination of temperature and relative humidity conditions used shall be tested to determine
statistical validity. The sampled air volume or representative values of sampling time shall be measured
for all predetermined values. The mean of each measured variable and its standard deviation shall be
estimated. The results of the tests shall be given in the test report and the operating conditions shall be
documented.
6.4.2 Temperature
The tests shall be carried out at specified temperatures. At least two different conditions of temperature
(for example, about 10 °C and 25 °C) shall be used to cover the range as expected to be used by the
sampling device.
6.4.3 Relative humidity
The tests shall be carried out at two different conditions of relative humidity (e.g. at about 20 % and
50 % RH) for each temperature used in 6.4.2.
6.4.4 Experimental conditions for measuring the physical sampling efficiency of bioaerosol
sampling devices
The experimental conditions for measuring the physical sampling efficiency of bioaerosol sampling
devices shall be the same as those that are described in EN 13205. However, when bioaerosol sampling
devices are only designed to measure microorganisms and not microbial compounds, the calculation of
bias and accuracy relative to mass concentration is not required.
6.5 Reference sampling device
The reference sampling device used shall be well characterized and the samples shall be taken to allow
analysis of both, the culturable number and total number of microorganisms (see EN 13098). If
appropriate, two different reference sampling devices may be used.
6.6 Stabilization time
For the purposes of the tests in each instance where the sampling device is subjected to different test
conditions, the sampling device shall be allowed to stabilize.
Maximum time for stabilization should not exceed 30 min.
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6.7 Orientatio
...
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