Workplace exposure - Procedures for the determination of the concentration of chemical agents - Basic performance requirements

This European Standard specifies general requirements for the performance of procedures for the determination of the concentration of chemical agents in workplace atmospheres as required by the Chemical Agents Directive 98/24/EC. The requirements given apply to all measuring procedures, irrespective of the physical form of the chemical agent (gas, vapour, airborne particles), the sampling method and the analytical method used. This European Standard is applicable to all steps of a measuring procedure,
measuring procedures with separate sampling and analysis steps, and direct-reading devices.

Exposition am Arbeitsplatz - Verfahren zur Bestimmung der Konzentration von chemischen Arbeitsstoffen - Grundlegende Anforderungen an die Leistungsfähigkeit

Dieses Dokument legt grundlegende Anforderungen an die Leistungsfähigkeit von Verfahren zur Bestimmung der Konzentration chemischer Arbeitsstoffe in der Arbeitsplatzatmosphäre fest, wie seitens der Richtlinie über chemische Arbeitsstoffe 98/24/EG [13] gefordert. Diese Anforderungen sind für alle Schritte von Messverfahren, unabhängig vom physikalischen Zustand des chemischen Arbeitsstoffes (Gas, Dampf, luftgetragene Partikel), Messverfahren mit voneinander unabhängigen Probenahme- und Analyseverfahren sowie für direktanzeigende Messgeräte anzuwenden.
Dieses Dokument legt Anforderungen fest, die bei der Prüfung unter vorgeschriebenen Laborbedingungen aufgrund einer Vielzahl von Umgebungsbedingungen in der Praxis durch Messverfahren zu erfüllen sind.

Exposition sur les lieux de travail - Procédures pour déterminer la concentration d'agents chimiques - Exigences élémentaires relatives aux performances

Le présent document spécifie les exigences élémentaires de performances pour les procédures servant à déterminer la concentration des agents chimiques dans l'air des lieux de travail, comme requis par la Directive 98/24/CE relative aux agents chimiques [13]. Ces exigences s'appliquent à toutes les étapes des procédures de mesure, indépendamment de la forme physique de l'agent chimique (gaz, vapeur, particules en suspension dans l'air), aux procédures de mesure pour lesquelles le prélèvement et l'analyse sont deux étapes distinctes et aux instruments à lecture directe.
Le présent document spécifie les exigences auxquelles doivent satisfaire les procédures de mesure soumises à essai dans des conditions de laboratoire prescrites, ceci en raison du large éventail de conditions environnementales rencontrées dans la pratique.

Izpostavljenost na delovnem mestu - Postopki za določevanje koncentracije kemičnih agensov - Osnovne zahtevane lastnosti

General Information

Status
Published
Public Enquiry End Date
02-Mar-2020
Publication Date
15-Apr-2021
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
30-Mar-2021
Due Date
04-Jun-2021
Completion Date
16-Apr-2021

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SLOVENSKI STANDARD
SIST EN 482:2021
01-maj-2021
Nadomešča:
SIST EN 482:2012+A1:2016
Izpostavljenost na delovnem mestu - Postopki za določevanje koncentracije
kemičnih agensov - Osnovne zahtevane lastnosti

Workplace exposure - Procedures for the determination of the concentration of chemical

agents - Basic performance requirements
Exposition am Arbeitsplatz - Verfahren zur Bestimmung der Konzentration von
chemischen Arbeitsstoffen - Grundlegende Anforderungen an die Leistungsfähigkeit

Exposition sur les lieux de travail - Procédures pour déterminer la concentration d'agents

chimiques - Exigences élémentaires relatives aux performances
Ta slovenski standard je istoveten z: EN 482:2021
ICS:
13.040.30 Kakovost zraka na delovnem Workplace atmospheres
mestu
SIST EN 482:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 482:2021
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SIST EN 482:2021
EN 482
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2021
EUROPÄISCHE NORM
ICS 13.040.30 Supersedes EN 482:2012+A1:2015
English Version
Workplace exposure - Procedures for the determination of
the concentration of chemical agents - Basic performance
requirements

Exposition sur les lieux de travail - Procédures pour Exposition am Arbeitsplatz - Verfahren zur

déterminer la concentration d'agents chimiques - Bestimmung der Konzentration von chemischen

Exigences élémentaires relatives aux performances Arbeitsstoffen - Grundlegende Anforderungen an die

Leistungsfähigkeit
This European Standard was approved by CEN on 8 February 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 482:2021 E

worldwide for CEN national Members.
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SIST EN 482:2021
EN 482:2021 (E)

Contents Page

European foreword ....................................................................................................................................................... 3

Introduction .................................................................................................................................................................... 4

1 Scope .................................................................................................................................................................... 5

2 Normative references .................................................................................................................................... 5

3 Terms and definitions ................................................................................................................................... 6

4 Classification ..................................................................................................................................................... 6

4.1 General ................................................................................................................................................................ 6

4.2 Screening measurements of time-weighted average concentration ............................................ 6

4.3 Screening measurements of variation of concentration in time and/or space ........................ 6

4.4 Measurements for comparison with OELVs .......................................................................................... 6

4.5 Periodic measurements ................................................................................................................................ 6

5 Performance requirements ......................................................................................................................... 7

5.1 General ................................................................................................................................................................ 7

5.2 Screening measurements of time-weighted average concentration ............................................ 7

5.3 Screening measurements of variation of concentration in time and/or space ........................ 7

5.4 Measurements for comparison with limit values and periodic measurements ....................... 7

5.4.1 General ................................................................................................................................................................ 7

5.4.2 Unambiguity ...................................................................................................................................................... 7

5.4.3 Selectivity ........................................................................................................................................................... 7

5.4.4 Averaging time ................................................................................................................................................. 8

5.4.5 Measuring range .............................................................................................................................................. 8

5.4.6 Expanded uncertainty ................................................................................................................................... 8

5.4.7 Chemical agents where compliant methods are not available ....................................................... 9

5.5 Composite procedures .................................................................................................................................. 9

5.6 Transport, handling and/or storage ........................................................................................................ 9

5.7 Environmental conditions ........................................................................................................................... 9

5.8 Description of measuring procedure ....................................................................................................... 9

5.9 Dimension of result ........................................................................................................................................ 9

5.10 Additional requirements ........................................................................................................................... 10

6 Test method and calculation of uncertainty of measurement ..................................................... 11

7 Validation report .......................................................................................................................................... 12

Annex A (informative) Structure of a method description......................................................................... 13

Annex B (informative) Calculation of uncertainty of measurement....................................................... 14

Bibliography ................................................................................................................................................................. 22

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SIST EN 482:2021
EN 482:2021 (E)
European foreword

This document (EN 482:2021) 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 document corresponds to ISO 20581:2016, published by the International Organization for

Standardization (ISO) which contains a modified version of EN 482:2012+A1:2015.

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 September 2021, and conflicting national standards

shall be withdrawn at the latest by September 2021.

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 482:2012+A1:2015.

The major technical changes between this document and the previous edition are as follows:

a) standard title adapted to the wording used in the scope;
b) 4.4, which comprised two subclauses, was revised;
c) recommendation regarding exposure peaks inserted in 5.4.4;
d) 5.4.7 reformulated to improve comprehensibility;

e) new Table 2 with additional requirements for the testing parameters added to 5.10;

f) Annex A specified more in detail;
g) new subclause B.9 for blank subtraction added.

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 482:2021
EN 482:2021 (E)
Introduction

National laws and regulations require the assessment of the exposure of a worker to chemical agents in

workplace atmospheres. One way of assessing such exposure is to measure the concentration of a

chemical agent in the air in the worker's breathing zone. The procedures used for such measurements

should provide reliable and valid results for the comparison purpose of exposure measurements with

occupational exposure limit values (OELVs) and for the provision of acceptable control strategies.

This document introduces basic requirements to fulfil the measurement procedures in the process of

quantitative exposure assessment. Specific European Standards and International Standards have been

prepared for different types of measuring procedures and measuring devices. These include standards

for airborne particle samplers (EN 13205, all parts), diffusive samplers (EN 838 and ISO 16107),

pumped samplers (EN ISO 22065), short-term detector tubes (EN ISO 17621), personal sampling

pumps (EN ISO 13137), metals and metalloids in airborne particles (EN ISO 21832), mixtures of

airborne particles and vapour (EN 13936) and direct-reading instruments for toxic gases and vapours

(EN 45544, all parts). In these specific documents, additional requirements have been included for the

procedure or device in question, so that the basic requirements of this document are not compromised.

Where no specific European Standard and/or International Standard exist, only the basic requirements

apply.

Performance requirements given in this document are intended to apply under environmental

conditions present at the workplace. However, because a wide range of environmental conditions are

encountered in practice, this document specifies requirements that have to be fulfilled by measuring

procedures when tested under prescribed laboratory conditions.

It is the user's responsibility to choose the appropriate procedures or devices that meet the

requirements of this document. One way of doing this is to obtain information or confirmation from the

provider of a procedure or the manufacturer of a device. Type-testing or, more generally, assessment of

the performance of procedures or devices, can be undertaken by the manufacturer, user, testing house

or research and development laboratory, as is most appropriate. A number of existing procedures for

workplace measurements have either been tested over a part of the required minimum measuring

range, but not over the entire range, or have not been tested for all environmental influences and

potential interferences. If these partially validated procedures meet the performance requirements of

this document, they can be used at present. Nevertheless, these procedures should be tested over the

full ranges as soon as is reasonably practicable.
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SIST EN 482:2021
EN 482:2021 (E)
1 Scope

This document specifies basic performance requirements for procedures for the determination of the

concentration of chemical agents in workplace atmospheres as required by the Chemical Agents

Directive 98/24/EC [13]. These requirements apply to all steps of measuring procedures regardless of

the physical form of the chemical agent (gas, vapour, airborne particles), measuring procedures with

separate sampling and analytical methods, and direct-reading instruments.

This document specifies requirements that are fulfilled by measuring procedures when tested under

prescribed laboratory conditions due to a wide range of environmental conditions encountered in

practice.
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 838, Workplace exposure - Procedures for measuring gases and vapours using diffusive samplers -

Requirements and test methods
EN 1540, Workplace exposure - Terminology

EN 13205 (all parts), Workplace exposure - Assessment of sampler performance for measurement of

airborne particle concentrations

EN 13936, Workplace exposure - Procedures for measuring a chemical agent present as a mixture of

airborne particles and vapour - Requirements and test methods

EN 45544 (all parts), Workplace atmospheres - Electrical apparatus used for the direct detection and

direct concentration measurement of toxic gases and vapours

EN ISO 13137, Workplace atmospheres - Pumps for personal sampling of chemical and biological agents -

Requirements and test methods (ISO 13137)

EN ISO 17621, Workplace atmospheres - Short term detector tube measurement systems - Requirements

and test methods (ISO 17621)

EN ISO 21832, Workplace air - Metals and metalloids in airborne particles - Requirements for evaluation

of measuring procedures (ISO 21832)

EN ISO 22065, Workplace air - Gases and vapours - Requirements for evaluation of measuring procedures

using pumped samplers (ISO 22065)

ISO 78-2, Chemistry - Layouts for standards — Part 2: Methods of chemical analysis

ISO 16107, Workplace atmospheres - Protocol for evaluating the performance of diffusive samplers

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SIST EN 482:2021
EN 482:2021 (E)
3 Terms and definitions

For the purposes of this document, the terms and definitions given in EN 1540 apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
4 Classification
4.1 General

In this document, measurements are classified according to their purposes. These classifications are

based upon the measurement strategy in EN 689.
4.2 Screening measurements of time-weighted average concentration

Screening measurements of time-weighted average concentration are performed to obtain

semiquantitative information on exposure levels. Such information is used to identify potential health

hazards, and to estimate the risk to health based on the likely severity of harm and the probability of its

occurrence. These measurements can also determine if the exposure is significantly below or above the

OELV. Apparatus intended for detection and concentration measurements of chemical agents, that meet

the requirements of this document and is capable of reporting the time weighted average, can be used.

4.3 Screening measurements of variation of concentration in time and/or space

Screening measurements of variation of concentration in time and/or space are used to provide

information on the likely pattern of the concentration of chemical agents in the air and to identify

locations and periods of elevated exposure. The screening measurements also provide information on

the location and intensity of emission sources and to estimate the effectiveness of ventilation or other

technical measures. Apparatus intended for detection and concentration measurements of chemical

agents, that meet the requirements of this document, can be used.
4.4 Measurements for comparison with OELVs

Provided the method meets established acceptable uncertainty criteria, measurements can be made for

comparison with OELVs. Measurements can be taken to determine whether a worker’s exposure

exceeds the OELV initially and repeated after any significant change in working conditions, industrial

process, products or chemicals or OELV.
4.5 Periodic measurements

Periodic measurements are used to determine whether exposure conditions have changed since the

measurements for comparison with OELVs were performed, or whether control measures remain

effective. The interval between measurements should be established based on the initial occupational

exposure assessment or subsequent amendments to it.

NOTE Since the composition of the workplace atmosphere will have been investigated during the initial

occupational exposure assessment and the composition is known not to vary over time, it can be appropriate for

periodic measurements to use procedures with lower selectivity.
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SIST EN 482:2021
EN 482:2021 (E)
5 Performance requirements
5.1 General

Performance requirements for measuring procedures depend on the purpose for which they are used.

The performance requirements for screening measurements are less stringent than for measurements

for the comparison with limit values and periodic measurements. Therefore, the performance

requirements for screening measurements in 5.2 and 5.3 are only given in general terms.

5.2 Screening measurements of time-weighted average concentration

The purpose of these measurements is described in 4.2. The measuring procedures shall include the

following:
a) adequate selectivity for the chemical agent;
b) averaging time less than or equal to the limit value reference period;
c) measuring range that includes the limit value; and
d) expanded uncertainty that is fit for purpose.
5.3 Screening measurements of variation of concentration in time and/or space

The purpose of these measurements is described in 4.3. The measuring procedures shall include the

following:
a) adequate selectivity for the chemical agent;

b) short averaging time (for variation of concentration in time ≤ 5 min; for variation of concentration

in space ≤ 15 min);
c) measuring range that is fit for purpose; and
d) expanded uncertainty that is fit for purpose.
5.4 Measurements for comparison with limit values and periodic measurements
5.4.1 General

A measuring procedure for a given limit value which meets the requirements given in 5.4.2 to 5.4.6 is

called compliant method.
5.4.2 Unambiguity

A measuring procedure shall produce an unambiguous result for the concentration of the chemical

agent being measured in the specified measuring range, i.e. an analytically determined value shall

correspond to one concentration only within a known uncertainty.
5.4.3 Selectivity

The measuring procedure shall contain appropriate information about the nature and magnitude of any

interference.
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SIST EN 482:2021
EN 482:2021 (E)

Requirements on selectivity vary from case to case, depending on what is known in advance about the

workplace air. If the identity of all contaminants present is not known in advance then the measuring

procedure shall have a high selectivity. If the identity of all contaminants is known prior to

measurement and there are no interferents present, then a measuring procedure with a low selectivity

can be used.

Where a particle size fraction, as defined in EN 481, is specified for an OELV, procedures for measuring

chemical agents present as airborne particles shall prescribe a method for sampling the specified

particle size fraction.

NOTE In addition to samplers meeting the requirements of EN 481, there are samplers which themselves

define the sample (see EN 13205 series).

If different limit values are set for different species of a chemical agent, then the measuring procedure

shall determine the individual species concerned.
5.4.4 Averaging time

The averaging time is equal to the sampling time, which shall be less than or equal to the limit value

reference period. Depending on the sampling techniques, the sampling time can vary.

NOTE A full shift average concentration, typically the 8 h time-weighted concentration, gives a representative

description of the occupational exposure situation.

Exposure peaks that can occur systematically or randomly during the shift should fulfil the short-term

exposure limit conditions (see 5.4.6), if any.
5.4.5 Measuring range

The measuring range of the procedure listed in Table 1 shall cover at least the concentrations from

0,1 times to 2 times the limit value for long-term measurements, and from 0,5 times to 2 times the limit

value for short-term measurements.

NOTE Reference [9] provides a list of International limit values for chemical agents (Occupational exposure

limits, OELs).
5.4.6 Expanded uncertainty
The requirements for expanded uncertainty are given in Table 1.

Table 1 — Expanded uncertainty requirements for measurements for comparison with limit

values and periodic measurements
Reference period Measuring range Relative Relative expanded
expanded uncertainty
uncertainty (mixtures of airborne
particles and vapour)
short-term 0,5 times to 2 times limit ≤ 50 % ≤ 50 %
(for example, value
15 min)
long-term 0,1 times to < 0,5 times ≤ 50 % ≤ 50 %
limit value
long-term 0,5 times to 2 times limit ≤ 30 % ≤ 50 %
value
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SIST EN 482:2021
EN 482:2021 (E)

NOTE Variation of exposure to chemical agents in the workplace can be significantly greater than indicated

by the uncertainty of a single measurement calculated according to this document. This is due to the temporal and

spatial variability of workplace exposure.
5.4.7 Chemical agents where compliant methods are not available

Limit values are determined by authorities independently from those developing measuring

procedures. If a measuring procedure is not available for a given limit value which meets the

requirements given in 5.4.5 and 5.4.6 a measuring procedure should be used whose performance is

closest to the requirements. The method employed should clearly state its limitations when measuring

at the exposure limit.
5.5 Composite procedures

The performance requirements detailed in 5.2, 5.3 and 5.4 shall be fulfilled for the whole measuring

procedure even if the measuring procedure consists of several distinct steps, for example, preparation

of equipment, sampling, transport and storage, sample preparation and analysis. Each step of the

measuring procedure may be tested individually and can be combined as a whole.
5.6 Transport, handling and/or storage

Transport, handling and/or storage of samples, if appropriate, shall be carried out in such a way that

the physical and chemical integrity is maintained between sampling and analysis.
5.7 Environmental conditions

The effect of environmental conditions (for example, temperature, humidity, atmospheric pressure,

and/or air speed) on the performance of the method shall be tested in the laboratory. Performance

requirements concerning unambiguity, selectivity, expanded uncertainty, minimum measuring range

and averaging time shall be fulfilled under the conditions likely to be encountered in the workplace.

NOTE Due to the time, cost, and effort involved, it is not practicable to carry out a comprehensive evaluation

of environmental influences in the field and therefore laboratory tests are specified in this document. However,

field tests can provide valuable information on the performance of measurement methods (for example,

interferences from nearby workplaces).

The range of environmental conditions under which the performance requirements of 5.2 to 5.5 are

fulfilled shall be specified in the measuring procedure.
5.8 Description of measuring procedure

The measuring procedure shall be documented in accordance with ISO 78-2. Any clause or subclause

which is unnecessary in a particular case may be omitted, and others, if required, may be added in the

most appropriate places. The description shall contain all necessary information to perform the

measuring procedure, including information about the attainable expanded uncertainty, measuring

range, averaging time, interferences and environmental or other conditions that can influence the

performance of the measuring procedure.

If correction factors are applied, for example, for a known and explainable bias due to environmental

influences, these shall be justified in the measuring procedure.

NOTE An example for the structure of a method description based on ISO 78-2 is given in Annex A.

5.9 Dimension of result

The final measurement result shall be expressed in the same units as those of the limit value. This can

be achieved directly or by means of a suitable conversion.
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SIST EN 482:2021
EN 482:2021 (E)

This requirement is not obligatory for screening measurements of the variation of concentration in time

and/or space.
5.10 Additional requirements

In addition to the requirements given in 5.2 to 5.9, further requirements specified in EN 838,

EN 13205 (all parts), EN 13936, EN 45544 (all parts), EN ISO 13137, EN ISO 17621, EN ISO 21832,

EN ISO 22065 and ISO 16107 shall be met for particular types of measuring procedures and devices, as

appropriate.
Table 2 lists additional requirements of testing parameters.
Table 2 — Additional requirements of testing parameters
Standard Required testing parameters
EN 838 Quantification limit of the measuring procedure, analytical recovery,
nominal uptake rate, air velocity/sampler orientation, sampler leak test,
shelf life, and marking.

EN 13205 (all parts) Specimen variability, pump design safety and electrical safety, and sampler

evaluation.
EN 13936 Comply with the requirements of this document, EN 13205 (all parts),
EN ISO 13137, EN ISO 21832 and EN ISO 22065.

EN 45544 (all parts) Instrument vibration and drop test, measurement of deviations, alarm

system including audible alarm, set point(s), and response time, flow failure
warning, warm-up time, time of response and recovery, addition of
sampling probe, field verification kit, gas concentrations above the
measuring range, electrical fault signal, extended operation under standard
test gas, orientation, electrical tests including battery capacity, mains power
supply, time weighted average function, and electromagnetic compatibility,
and instrument drift tests.

EN ISO 13137 Features and mass of pumps, design safety, operating time, start-up and

long-term performance, short-term interruption of air flow, mechanical
strength, timer accuracy, electromagnetic compatibility, explosion hazard,
charger, and marking.

EN ISO 17621 Scale, packing of the tubes, interferences, overloading, evaluation of stain,

shelf life, marking and mechanical strength for detector tubes; Explosion
hazard, stroke volume, leakage, and mechanical strength and durability for
detector tube pumps.

EN ISO 21832 Sampler evaluation, detection limit (LOD) and quantification limit (LOQ) of

the measuring procedure, analytical recovery, and interferences.

EN ISO 22065 Quantification limit of the measuring procedure, analytical recovery,

sampler leak test, shelf life, marking, flow resistance, and sampler
breakthrough test.

ISO 16107 Bias relative to manufacturer-specified sampling rate, variation in sampling

rate (for example, from poor sampler dimension tolerance), effects of wind,
temperature, humidity, target concentration itself, and diffusive loss from
sampler.
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SIST EN 482:2021
EN 482:2021 (E)
6 Test method and calculation of uncertainty of measurement
6.1 Estimate the expanded uncertainty of results obta
...

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