Workplace exposure - Volumetric bioaerosol samplers - General requirements and evaluation of performance

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.

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 - Naprave za volumetrijsko vzorčenje bioaerosolov - Splošne zahteve za uporabo in vrednotenje lastnosti

General Information

Status
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Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
15-Dec-2021
Completion Date
15-Dec-2021

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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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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

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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