SIST EN 689:2018
(Main)Workplace exposure - Measurement of exposure by inhalation to chemical agents - Strategy for testing compliance with occupational exposure limit values
Workplace exposure - Measurement of exposure by inhalation to chemical agents - Strategy for testing compliance with occupational exposure limit values
This European standard specifies a strategy to perform representative measurements of exposure by inhalation to chemical agents in order to demonstrate the compliance with occupational exposure limit values.
Exposition am Arbeitsplatz - Messung der Exposition durch Einatmung chemischer Arbeitsstoffe - Strategie zur Überprüfung der Einhaltung von Arbeitsplatzgrenzwerten
Diese Europäische Norm legt eine Strategie zur Durchführung repräsentativer Expositionsmessungen in Bezug auf die Inhalation chemischer Arbeitsstoffe fest, um die Einhaltung von Beurteilungsmaßstäben (OELVs) nachweisen zu können.
Diese Europäische Norm ist nicht anwendbar auf OELVs mit Referenzdauer von weniger als 15 min.
Exposition sur les lieux de travail - Mesurage de l'exposition par inhalation d'agents chimiques - Stratégie pour vérifier la conformité à des valeurs limites d'exposition professionnelle
La présente Norme européenne spécifie une stratégie pour effectuer des mesurages représentatifs de l’exposition par inhalation à des agents chimiques afin de démontrer la conformité aux valeurs limites d’exposition professionnelle (VLEP).
La présente Norme européenne n’est pas applicable aux VLEP dont les périodes de référence sont inférieures à 15 min.
Izpostavljenost na delovnem mestu - Merjenje izpostavljenosti pri vdihavanju kemičnih agensov - Strategija preskušanja skladnosti z mejnimi vrednostmi za poklicno izpostavljenost
Ta evropski standard določa strategijo za izvajanje reprezentativnih meritev izpostavljenosti kemičnim snovem zaradi vdihavanja z namenom dokazovanja skladnosti z mejnimi vrednostmi za poklicno izpostavljenost.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 689:2018
01-julij-2018
1DGRPHãþD
SIST EN 689:1998
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Workplace exposure - Measurement of exposure by inhalation to chemical agents -
Strategy for testing compliance with occupational exposure limit values
Exposition am Arbeitsplatz - Messung der Exposition durch Einatmung chemischer
Arbeitsstoffe - Strategie zur Überprüfung der Einhaltung von Arbeitsplatzgrenzwerten
Exposition sur les lieux de travail - Mesurage de l'exposition par inhalation d'agents
chimiques - Stratégie pour vérifier la conformité à des valeurs limites d'exposition
professionnelle
Ta slovenski standard je istoveten z: EN 689:2018
ICS:
13.040.30 Kakovost zraka na delovnem Workplace atmospheres
mestu
SIST EN 689:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 689:2018
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SIST EN 689:2018
EN 689
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2018
EUROPÄISCHE NORM
ICS 13.040.30 Supersedes EN 689:1995
English Version
Workplace exposure - Measurement of exposure by
inhalation to chemical agents - Strategy for testing
compliance with occupational exposure limit values
Exposition sur les lieux de travail - Mesurage de Exposition am Arbeitsplatz - Messung der Exposition
l'exposition par inhalation d'agents chimiques - durch Einatmung chemischer Arbeitsstoffe - Strategie
Stratégie pour vérifier la conformité à des valeurs zur Überprüfung der Einhaltung von
limites d'exposition professionnelle Arbeitsplatzgrenzwerten
This European Standard was approved by CEN on 2 March 2018.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 689:2018 E
worldwide for CEN national Members.
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SIST EN 689:2018
EN 689:2018 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions and abbreviations . 6
3.1 Terms and definitions . 6
3.2 Abbreviations . 7
4 General . 7
5 Occupational exposure assessment. 9
5.1 Basic characterization . 9
5.1.1 General . 9
5.1.2 Identification of chemical agents and other information required . 9
5.1.3 Review of workplace factors . 10
5.1.4 Estimation of exposure . 10
5.1.5 Decisions . 11
5.2 Sampling strategy. 11
5.2.1 Constitution of Similar Exposure Groups (SEGs) . 11
5.2.2 Specifying the measuring procedure . 12
5.3 Performing exposure measurements . 13
5.4 Validation of results and SEGs . 13
5.4.1 General . 13
5.4.2 Validation of measurement results . 13
5.4.3 Validation of SEGs . 14
5.5 Comparison of results with OELVs . 14
5.5.1 General . 14
5.5.2 Preliminary test . 15
5.5.3 Statistical test . 15
6 Report . 16
7 Periodic reassessment . 16
Annex A (informative) Assessment of exposure . 18
A.1 General . 18
A.2 Workplaces with constant conditions . 20
A.3 Shortened exposure at workplaces with constant working conditions . 20
A.4 Workplaces involving occasional exposure . 20
A.5 Stationary workplaces with irregular exposure . 21
A.6 Workers who move from a workplace to another with irregular exposure . 21
A.7 Workplaces with unpredictable, constantly changing exposure . 22
A.8 Outdoor workplaces . 22
A.9 Underground workplaces . 22
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EN 689:2018 (E)
Annex B (informative) Occupational exposure limit values for compliance testing . 24
Annex C (informative) Simultaneous workplace exposure to several chemical agents . 26
C.1 General . 26
C.2 Tier 1: Exposure index (I ) . 26
E
C.3 Tier 2: Additive effect exposure index (I ) . 27
AE
C.4 Other approaches . 28
Annex D (informative) Exposure profile and sampling duration. 29
D.1 General . 29
D.2 Measurement for testing compliance with 8 h- OELV . 29
D.3 Measurement for testing compliance with short-term limit value . 34
Annex E (informative) Check of exposure measurements distribution, and identification of
exceptional exposure within the SEG . 35
E.1 General . 35
E.2 Graphical method . 35
E.2.1 Principle . 35
E.2.2 Plotting . 36
E.2.3 Example . 36
E.2.4 Examples of SEGs requiring further consideration . 37
E.2.4.1 General . 37
E.2.4.2 SEG consisting of two groups . 38
E.2.4.3 Some individuals with exceptional exposure . 39
E.2.4.4 Distributions appearing to be not lognormal. . 40
E.3 Statistical methods for the validation of SEGs . 41
Annex F (informative) Testing compliance with OELVs . 42
F.1 General . 42
F.2 SEG compliance test for at least six exposure measurements . 42
F.3 Decision . 43
Annex G (informative) Exposure calculation with a work shift longer than 8h . 45
Annex H (informative) Exposure below the limit of quantification . 46
H.1 General . 46
H.2 Principle . 46
H.3 Example . 46
H.4 Uncertainty . 49
H.5 Software . 50
Annex I (informative) Interval for periodic measurements . 51
Bibliography . 53
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SIST EN 689:2018
EN 689:2018 (E)
European foreword
This document (EN 689:2018) 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 November 2018, and conflicting national standards
shall be withdrawn at the latest by November 2018.
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 689:1995.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
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Introduction
This European Standard deals with the measurement of exposure to chemical agents in workplace
atmospheres, and in particular with measurement strategy for comparing workers' exposure by
inhalation with occupational exposure limit values (OELVs). Other parts of management of exposure of
workers are not dealt with in detail in this European Standard.
Within this European Standard, compliance means that workers’ time weighted average workplace
exposure is below an OELV with a corresponding reference period. OELVs include legal values and
other numerical criteria (see Annex B).
Representative measurement of workplace exposure to chemical agents is difficult, because of the
variability of exposure. Processes and products affecting exposure are numerous. Different workplace
conditions can correspond to different generation rates, can involve a variety of chemical agents and
can therefore present specific exposure conditions. Exposure can be affected by the distance of the
exposed workers from emission sources; and parameters such as emission intensity, ventilation,
climatic conditions, seasonal variations and the controls applied can also have a very marked influence.
The spatial and temporal variabilities of exposure conditions are further enhanced by workers'
practices and activities themselves.
The sampling equipment introduces its own limitations, and the analytical steps add further difficulties
and uncertainties.
This European Standard is applicable for measuring procedures that fulfil the requirements of EN 482.
If a measuring procedure does not fulfil these requirements some parts of the procedure described in
this European Standard cannot be applied.
To assess the exposure of workers to chemicals and to state with certainty that it does not exceed the
OELVs (short-term or long-term) would require measurement of the exposure of every worker for
every working day. Unfortunately while this approach is possible for some agents such as ionizing
radiation, it is not feasible or practical for many chemical agents due to limitations of the measurement
techniques and costs.
The strategy described in this European Standard gives a procedure for the employer or other
stakeholders to overcome the problem of variability and to use a relatively small number of
measurements to demonstrate with a high degree of confidence that workers are unlikely to be exposed
to concentrations exceeding the OELVs. To reduce the number of exposure measurements, and
therefore the cost of assessment, personal air samples are collected among workers within similar
exposure groups (SEGs). A single measurement or even several measurements below the limit value can
be insufficient to reliably demonstrate compliance without using a statistical test like the one proposed
in this European Standard.
Respiratory protective equipment (RPE) is used to reduce the amount of the chemical agent that is
inhaled by the worker. However, this European Standard does not take into account the use and
effectiveness of RPE in testing compliance with the OELV.
Before any measurements are performed, it is essential for an appraiser to conduct a basic
characterization in order to collect relevant information on workplace factors, and the available
information on exposure in the workplace concerned. This includes information on variation of
exposure with time of day and season of the year, so that the measurement is representative.
If the basic characterization shows that exposure is probably higher than the OELV, then it is
recommended to reduce exposure by risk management measures (RMM) before measurements are
planned for compliance testing.
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SIST EN 689:2018
EN 689:2018 (E)
1 Scope
This European Standard specifies a strategy to perform representative measurements of exposure by
inhalation to chemical agents in order to demonstrate the compliance with occupational exposure limit
values (OELVs).
This European Standard is not applicable to OELVs with reference periods less than 15 min.
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 482, Workplace atmospheres — General requirements for the performance of procedures for the
measurement of chemical agents
EN 1540, Workplace exposure - Terminology
3 Terms and definitions and abbreviations
3.1 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 1540 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1.1
appraiser
person who is sufficiently trained and experienced in occupational hygiene principles, working and
measurement techniques, to conduct the part of the assessment they are performing according to the
state of the art
Note 1 to entry: The appraiser may be supported by a team of qualified persons.
3.1.2
exposure profile
description of the exposure variations to a chemical agent in relation to the definable series of activities
from the periods under consideration
Note 1 to entry: See Annex D.
3.1.3
similar exposure group
SEG
group of workers having the same general exposure profile for the chemical agent(s) being studied
because of the similarity and frequency of the tasks performed, the materials and processes with which
they work, and the similarity of the way they perform the tasks
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EN 689:2018 (E)
3.2 Abbreviations
AM arithmetic mean
CAS chemical abstracts service
DMEL derived minimum effect level
DNEL derived no-effects level
EC number European community number
GSD geometric standard deviation
GM geometric mean
H hour
LOQ limit of quantification
OELV occupational exposure limit value
RPE respiratory protective equipment
RMM risk management measures
SD standard deviation
SEG similar exposure group
WS work shift
4 General
The assessment of occupational exposure to chemical agents based on air samples requires the
development of a strategy including different phases which shall be conducted by an appraiser.
The strategy consists of an initial workplace exposure assessment (described in Clauses 5 and 6) and
then periodic reassessment (see Clause 7). The initial workplace exposure assessment comprises
different phases:
— basic characterization of the workplaces;
— constitution of similar exposure groups;
— selection of a suitable measuring procedure;
— performing exposure measurements;
— validation of exposure measurement results and SEGs;
— comparison of results with OELVs;
— reporting of results.
The sampling strategy comprises the constitution of SEGs and the definition of measuring procedures. If
the initial workplace exposure assessment indicates non-compliance with OELVs for some SEGs, control
measures shall be implemented and a new initial workplace exposure assessment shall be conducted.
Following the initial workplace exposure assessment, periodic reassessments shall be conducted. When
significant changes occur at the workplace that may affect exposure conditions, the appraiser shall
decide whether a new initial workplace exposure assessment shall be conducted.
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EN 689:2018 (E)
Figure 1 gives a schematic overview of the procedures described in this European Standard.
Figure 1 —Schematic overview of the strategy
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EN 689:2018 (E)
5 Occupational exposure assessment
5.1 Basic characterization
5.1.1 General
Prior to exposure measurements, the workplace and the related exposure profile under consideration
shall be considered.
The basic characterization of exposure determinants is in three steps:
— identification of chemical agents and other information required;
— review of workplace factors;
— estimation of exposure.
All the information collected during the basic characterization shall be used to:
— decide whether measurements are necessary or not (see 5.1.4);
— constitute the different SEGs.
Use of exposure monitoring devices able to give an instant feedback to the user, either as a single or a
continuous reading (so called direct-reading instruments), can give valuable information about
approximate exposure level, the exposure pattern, and spatial, time and worker variability of the
exposure.
5.1.2 Identification of chemical agents and other information required
The preparation of a list of all chemical agents in the workplace and the relevant information concerned
is an essential first step to the identification of the potential for hazardous exposure. The safety data
sheets and other available information are useful to establish the list. The list shall include any of the
following:
— raw materials, primary products, impurities, intermediates, final products, reaction and process
products and by-products, etc;
— the individual chemical agents, identified with chemical registration numbers (e.g. CAS#, EC#);
— hazardous properties, classification and labelling;
— appropriate OELVs depending on the goal of the assessment (see Annex B);
— whether dermal and oral exposure of the chemical agents is relevant (this European Standard only
deals with measuring inhalation exposure, but knowledge of other routes can be important in the
management of exposure);
— additional information such as amount used, vapour pressure, temperature, saturation
concentration, dustiness, etc.
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EN 689:2018 (E)
5.1.3 Review of workplace factors
The work processes and procedures shall be evaluated to gauge the exposure and the exposure profile
to chemical agents by a detailed review of workplace factors, such as:
— work organization: activity, task, job title, work shift system, job functions, etc.;
— processes and techniques (type of processes, temperature, pressure, etc.);
— workplace layout and configuration, including confined spaces, open air, etc.;
— safety precautions and procedures (restricted area, etc.);
— cleanliness and tidiness of workplace;
— ventilation installations and other forms of engineering control and any information on their
performance;
— emission sources and locations of high concentrations ;
— periods, frequencies and durations of exposure taking into account variation of exposure with time
of day and season of the year;
— work load;
— worker behaviour, or
— activity or production rate indicators.
5.1.4 Estimation of exposure
The appraiser shall collect available information to allow reliable estimates of the exposure of the
workers. Annex A gives guidance on this.
Possible sources of information include:
— earlier measurement results in this workplace, including from direct-reading instruments;
— measurement results from comparable installations or work processes (databases, literature, etc.);
— calculations based on relevant quantitative information;
— exposure modelling.
A decision that an exposure is much lower than the OELV should be made, for example in the following
cases:
— the release capability is low because of the working conditions and the substance properties (e.g.
low vapour pressure, high boiling point with low processing temperature, low dust-forming
behaviour);
— the operational conditions cannot give rise to the formation of aerosols;
— only small quantities are used;
— only low emissions are possible, for example because of small source surfaces or short activity
duration (<15 min).
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The estimates shall be used to make a decision in 5.1.5.
The estimates shall also be used to verify whether the sampling and analysis techniques that are
proposed for the measurements are adequate.
5.1.5 Decisions
The results of basic characterization lead to one of the following decisions:
— the exposure is higher than the OELV (non-compliance); then the appraiser shall report this (see
Clause 6) and advise on a programme to reduce exposures, using RMM, before making
measurements to test compliance;
— the exposure is well below the OELV (compliance); then the appraiser shall decide if measurements
are necessary or not. If measurements are unnecessary, the appraiser shall report this (see
Clause 6) and advise on a reassessment (see Clause 7);
— the available information on exposure is insufficient to decide on compliance with the OELV; then
the appraiser shall continue to develop a sampling plan (see 5.2).
5.2 Sampling strategy
5.2.1 Constitution of Similar Exposure Groups (SEGs)
In practice it is usually not possible to measure the exposure of each worker during each working day.
In order to obtain quantitative data from exposure measurements that allows assessment of compliance
with OELVs, an effective approach shall be taken that allows the most efficient use of resources.
This approach, based on the observation of working conditions, permits measurement of exp
...
SLOVENSKI STANDARD
oSIST prEN 689:2016
01-julij-2016
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Workplace exposure - Measurement of exposure by inhalation to chemical agents -
Strategy for testing compliance with occupational exposure limit values
Exposition am Arbeitsplatz - Messung der Exposition durch Einatmung chemischer
Arbeitsstoffe - Strategie zur Überprüfung der Einhaltung von Arbeitsplatzgrenzwerten
(Überarbeitung von EN 689:1995)
Exposition sur les lieux de travail - Mesurage de l'exposition par inhalation aux agents
chimiques - Stratégie de détermination de la conformité aux valeurs limites d'exposition
professionnelle
Ta slovenski standard je istoveten z: prEN 689
ICS:
13.040.30 Kakovost zraka na delovnem Workplace atmospheres
mestu
oSIST prEN 689:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 689:2016
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oSIST prEN 689:2016
DRAFT
EUROPEAN STANDARD
prEN 689
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2016
ICS 13.040.30 Will supersede EN 689:1995
English Version
Workplace exposure - Measurement of exposure by
inhalation to chemical agents - Strategy for testing
compliance with occupational exposure limit values
Exposition sur les lieux de travail - Mesurage de Exposition am Arbeitsplatz - Messung der Exposition
l'exposition par inhalation aux agents chimiques - durch Einatmung chemischer Arbeitsstoffe - Strategie
Stratégie de détermination de la conformité aux zur Überprüfung der Einhaltung von
valeurs limites d'exposition professionnelle Arbeitsplatzgrenzwerten (Überarbeitung von EN
689:1995)
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 689:2016 E
worldwide for CEN national Members.
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oSIST prEN 689:2016
prEN 689:2016 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 General . 6
5 Occupational exposure assessment. 8
5.1 Basic characterization . 8
5.1.1 General . 8
5.1.2 Identification of chemical agents . 9
5.1.3 Identification of determinants of exposure . 9
5.1.4 Estimation of exposure . 10
5.2 Sampling strategy. 10
5.2.1 Constitution of Similar Exposure Groups (SEGs) . 10
5.2.2 Measurement procedure . 11
5.3 Performing exposure measurements . 12
5.4 Validity of SEGs and results . 12
5.4.1 General . 12
5.4.2 Representativeness of measurement results . 12
5.4.3 Validity of SEGs . 13
5.5 Comparison of results with OELVs . 13
5.5.1 General . 13
5.5.2 Screening test . 14
5.5.3 Test of compliance with the OELV . 14
6 Communication of results . 15
7 Periodic measurements . 15
Annex A (informative) Assessment of exposure . 16
A.1 General . 16
A.2 Workplaces with constant conditions . 18
A.3 Shortened exposure at workplaces with constant working conditions . 18
A.4 Workplaces involving occasional exposure . 18
A.5 Stationary workplaces with irregular exposure . 19
A.6 Workers who move from a workplace to another with irregular exposure . 19
A.7 Workplaces with unpredictable, constantly changing exposure . 20
A.8 Outdoor workplaces . 20
A.9 Underground workplaces . 20
A.10 Unforeseen occurrences . 21
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Annex B (informative) Occupational exposure limit values for compliance testing . 22
Annex C (informative) Simultaneous occupational exposure to several chemical agents . 24
C.1 General . 24
C.2 Tier 1: Exposure index (I ) . 24
E
C.3 Tier 2: Additive effect exposure index (I ) . 25
AE
C.4 Tier 3 and 4 . 26
Annex D (informative) Exposure profile and sampling duration. 27
D.1 General . 27
D.2 Measurement in order to testing the compliance with 8 h- OELV . 27
D.3 Measurement in order to testing the compliance with short-term limit value . 30
Annex E (informative) Check of log-normality of exposure measurements, and
identification of exceptional exposure within the SEG . 32
E.1 General . 32
E.2 Graphical method . 32
E.2.1 Principle . 32
E.2.2 Plotting . 32
E.2.3 Example . 32
E.2.4 Examples of SEGs requiring further consideration . 34
E.2.4.1 General . 34
E.2.4.2 The SEG consists of two groups with different exposure distributions . 34
E.2.4.3 Some individuals with exceptional exposure. . 35
E.2.4.4 The distribution appears to be not lognormal. . 36
E.2.4.5 Exposure results with a large geometric standard deviation (GSD) . 37
E.3 Statistical methods for the validation of SEGs . 38
Annex F (informative) Statistical test for testing compliance with OELVs . 39
F.1 General . 39
F.2 SEG compliance test for at least six exposure measurements . 39
Annex G (informative) Exposure calculation for workers with unusual work shift . 41
Annex H (informative) Measurements below the limit of quantification . 42
H.1 General . 42
H.2 Principle . 42
H.3 Example . 42
H.4 Uncertainty . 45
H.5 Software . 45
Annex I (informative) Setting the interval for periodic measurements . 46
Bibliography . 48
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oSIST prEN 689:2016
prEN 689:2016 (E)
European foreword
This document (prEN 689:2016) 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 689:1995.
4
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oSIST prEN 689:2016
prEN 689:2016 (E)
Introduction
This European Standard deals with the measurement of exposure to chemical agents in workplace
atmospheres, and in particular with sampling strategy for comparing workers exposure by inhalation
with occupational exposure limit values (OELVs). Other parts of management of exposure of workers
are not dealt with in detail in this European Standard.
OELVs include legal values and other numerical criteria.
Representative measurement of occupational exposure to chemical agents is difficult, because of the
variability of exposure. Processes and products affecting exposure are numerous. Different occupational
conditions can correspond to different generation rates and involve a variety of chemical agents, and
can therefore present specific exposure conditions. Exposure can be affected by the distance of the
exposed worker from emission sources; and parameters such as emission intensity, ventilation, climatic
conditions, seasonal variations and the controls applied can also have a very marked influence. The
spatial and temporal variabilities of exposure conditions are further enhanced by the workers' practices
and activity itself.
The sampling equipment often introduces its own limitations, sometimes critical, as in aerosol fraction
measurement. The analytical steps add further difficulties or uncertainties, e.g. insufficient
identification or separation of chemical species, or interferences, or limits of quantification which are
too high. This can lead to practical problems to fulfil requirements of EN 482. As a consequence, some
parts of the described procedure in this European Standard cannot be applicable.
To assess the exposure of workers to chemicals and to state with certainty that it does not exceed the
OELVs (short-term or long-term) would therefore require measurement of the exposure of every
worker for every working day. Unfortunately while this approach is possible for some agents such as
ionizing radiation, it cannot be done for chemicals because of their diversity, limitations of the
measurement techniques, and costs.
The strategy described in this European Standard gives a procedure for the employer to overcome the
problem of variability and to use a relatively small number of measurements to demonstrate with a
high degree of confidence that workers are unlikely to be exposed to concentrations exceeding the
OELVs. To reduce the number of exposure measurements, and therefore the cost of assessment,
personal air samples are collected among workers within similar exposure groups (SEGs). A single
measurement or even several measurements below the limit value can be insufficient to reliably
demonstrate compliance without using a statistical test like the one described in this European
Standard.
Respiratory protective equipment (RPE) is used to reduce the amount of the chemical agent that is
inhaled by the worker. However, due to different regulations in different countries for dealing with
effectiveness of RPE in relation to compliance testing and the fact that OELVs are compared with
workplace airborne concentrations that are measured outside any RPE, this European Standard does
not take into account the use and effectiveness of RPE in testing compliance with the OELV.
Before any measurements are conducted, it is necessary for an appraiser to conduct a basic
characterization in order to collect relevant information on exposure determinants, and the available
information on exposure in the workplace concerned. This includes information on variation of
exposure with time of day and season of the year, so that the measurement is representative.
If the basic characterization shows that exposure is probably higher than the OELV, then it is
recommended to reduce exposure by risk management measures (RMM) before measurements are
planned for compliance testing.
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1 Scope
This European Standard specifies a strategy to perform representative measurements of exposure by
inhalation to chemical agents in order to demonstrate the compliance with occupational exposure limit
values (OELV).
This European Standard is not applicable to OELVs with reference periods less than 15 min.
NOTE Measurement for compliance testing is only one part of the management of exposure of workers. Some
background and advice on when measurement can be carried out is given in Annex A.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
EN 482, Workplace atmospheres — General requirements for the performance of procedures for the
measurement of chemical agents
EN 1540, Workplace exposure - Terminology
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 1540 and the following apply.
3.1
exposure profile
description of the exposure variations to a chemical agent during a workshift in relation to the definable
series of activities
Note 1 to entry: See Annex D.
3.2
similar exposure group
SEG
group of workers having the same general exposure profile for the chemical agent(s) being studied
because of the similarity and frequency of the tasks performed, the materials and processes with which
they work, and the similarity of the way they perform the tasks
3.3
work pattern
the definable series of activities from the periods under consideration
4 General
The assessment of occupational exposure to chemical agents based on air sampling requires the
development of a strategy including different phases which shall be conducted by an appraiser who is
sufficiently trained and experienced in occupational hygiene principles and techniques to conduct,
according to the state of the art, the part of the assessment for which he or she is performing.
The initial survey (as described in Clauses 5 and 6) conducted to assess exposure comprises different
phases:
— basic characterization or general evaluation of the workplaces;
— constitution of similar exposure groups;
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— definition of a measurement procedure;
— performing exposure measurements;
— validation of exposure measurements results and SEGs;
— comparison of results with occupational exposure limit value (OELVs);
— communication of results and compliance diagnosis.
The sampling strategy comprises the constitution of SEGs and the definition of measurement
procedures. If the initial survey indicates non-compliance with OELVs for some SEGs, control measures
shall be implemented and a new initial survey shall be conducted. Following the initial survey, periodic
reassessments shall be conducted. When significant changes occur at the workplaces and affect
exposure conditions, a new initial survey should be conducted.
Figure 1 gives a schematic overview of the procedures described in this European Standard.
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Figure 1 —Schematic overview of the strategy
5 Occupational exposure assessment
5.1 Basic characterization
5.1.1 General
Prior to conduct of exposure measurements, the workplace and the related exposure profile under
consideration shall be considered.
The basic characterization of exposure determinants is in three steps:
— identification of chemical agents (hazards, OELVs, physical properties);
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— identification of determinants of exposure;
— estimation of exposure.
All the information collected during the basic characterization shall be used to:
— decide whether measurements are necessary or not (see Annex A);
— constitute a priori the different SEGs.
Use of exposure monitoring devices able to give an instant feedback to the user, either as a single or a
continuous reading (so called direct-reading instruments), can give valuable information about
approximate exposure level, the exposure pattern, and spatial, time and worker variability of the
exposure.
If the basic characterization concludes that measurements are unnecessary, a report shall be written
explaining the reasons and the time of periodic reassessment.
5.1.2 Identification of chemical agents
The preparation of a list of all chemical agents in the workplace and the relevant information concerned
is an essential first step to the identification of the potential for hazardous exposure. The safety data
sheets and other available information are useful to establish the list. The list shall include, as far as any
of them can contribute significantly to exposures:
— primary products, impurities, intermediates, final products, reaction products and by-products,
etc.;
1) 2)
— the individual chemical agents, identified in preference by their CAS# or EINECS# ;
— appropriate OELVs depending on the goal of the assessment (see Annex B);
— whether dermal and oral exposure of the chemical agents is relevant (this European Standard only
deals with measuring inhalation exposure, but knowledge of other routes can be important in the
management of exposure);
— additional information like vapour pressure, saturation concentration, dustiness.
5.1.3 Identification of determinants of exposure
The work processes and procedures shall be evaluated to gauge the potential for exposure and the
exposure profile to chemical agents by a detailed review of workplace factors, such as
— work organization: activity, task, qualification, work shift system, job functions, etc.,
— production processes and techniques (type of processes, temperature, pressure, amount, etc.),
— workplace configuration (confined spaces, open air spaces, etc.),
— safety precautions and procedures (restricted area, etc.),
— personal protective equipment (PPE),
1)
Chemical Abstracts Service registry number
2)
Number for European Inventory of Existing Chemical Substances
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— ventilation installations and other forms of engineering control,
— emission sources and localized concentrations,
— periods, frequencies and durations of exposure,
— work load, or
— activity or production rate indicators.
5.1.4 Estimation of exposure
The estimation of potential exposures should permit the appraiser to obtain reliable quantitative
information about exposure of workers concerned, taking particular account of tasks with high
exposures (see Annex A).
The possible sources of information include
— earlier measurements,
— measurements from comparable installations or work processes,
— reliable calculations based upon relevant quantitative data, and
— exposure modelling.
The estimation of potential exposures shall determine whether it is necessary to perform
measurements especially when exposure is apparently much higher than the OELVs. In this case, it is
better to implement a program to reduce exposures, and then proceed to action before conducting
exposure measurements.
The information collected on the expected exposure levels shall also verify the adequacy of the
measurement techniques and analysis that are implemented
5.2 Sampling strategy
5.2.1 Constitution of Similar Exposure Groups (SEGs)
In practice it is usually not possible to measure the exposure of each worker during each working day.
In order to obtain quantitative data on exposure measurement, an approach shall be taken that allows
the most efficient use of resources.
This approach, based on the observation of working conditions, permits measurement of exposure of a
small number of workers belonging to a SEG for comparison with OELVs. Where exposure
measurements on some workers of the SEG indicate that the OELVs are met (compliance), then it is
considered that this is so for all workers in the SEG.
The SEG shall be constituted with information on the nature, level and duration of the tasks performed
in the working shifts throughout the year. This requires occupational hygiene expertise, and the
information most often includes
a) the job classification of the company, as a useful starting point,
b) the inventory of tasks within a job,
c) the task specific exposure nature and the estimation of the potential exposure level, collected in the
basic characterization (see 5.1) and if possible combined with the Operational Conditions (OC) and
Risk Management Measures (RMM) from a corresponding REACH Exposure Scenario, and
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d) the duration of the exposure within the shift and throughout the year, determined by the frequency
and period of the tasks.
The real level of exposure is determined as described in 5.3 and further of this European Standard.
A SEG can be constituted by one worker.
If a SEG includes worker from different locations, care shall be taken that the SEG meets definition 3.2 of
this European Standard.
5.2.2 Measurement procedure
The measurement procedure shall give results representative of worker exposure.
The sampling protocol aims to specify all the elements that guarantee to have representative and
reliable results of exposure measurements for comparison with limit values.
Sampling and analytical techniques shall be in accordance with standards or national recommended
methods. Sensitivity, specificity, capacity of samplers, transportation and stability of the sample shall be
particularly checked (see EN 482).
In order to measure the exposure of the worker at the workplace, personal sampling devices shall be
used whenever possible, attached to workers' clothing close to the breathing zone; workers should be
aware of how the sampling device works. Due to spatial variability of chemical air concentrations, static
samples are generally less representative of worker exposure.
The sampling duration is also an important factor that can influence the representativeness of exposure
measurements.
The sampling duration should be representative of the reference period of the limit value controlled
and should be established considering the concentration variability, the limit of quantification and other
perfor
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