SIST EN 17058:2019

SLOVENSKI STANDARD
SIST EN 17058:2019
01-januar-2019
Izpostavljenost na delovnem mestu - Ocena izpostavljenosti pri vdihavanju
nanopredmetov ter njihovih agregatov in aglomeratov
Workplace exposure - Assessment of exposure by inhalation of nano-objects and their
aggregates and agglomerates
Exposition am Arbeitsplatz - Beurteilung der inhalativen Exposition gegenüber Nano-
Objekten und deren Agglomeraten und Aggregaten
Exposition sur les lieux de travail - Évaluation de l’exposition par inhalation aux nano-
objets et à leurs agglomérats et agrégats
Ta slovenski standard je istoveten z: EN 17058:2018
ICS:
13.040.30 Kakovost zraka na delovnem Workplace atmospheres
mestu
SIST EN 17058:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 17058:2019

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SIST EN 17058:2019


EN 17058
EUROPEAN STANDARD

NORME EUROPÉENNE

November 2018
EUROPÄISCHE NORM
ICS 13.040.30
English Version

Workplace exposure - Assessment of exposure by
inhalation of nano-objects and their aggregates and
agglomerates
Exposition sur les lieux de travail - Évaluation de Exposition am Arbeitsplatz - Beurteilung der
l'exposition par inhalation aux nano-objets et à leurs inhalativen Exposition gegenüber Nanoobjekten und
agrégats et agglomérats deren Aggregaten und Agglomeraten
This European Standard was approved by CEN on 25 June 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 17058:2018 E
worldwide for CEN national Members.

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EN 17058:2018 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Symbols and abbreviations . 8
5 Measurement strategy . 10
5.1 General . 10
5.1.1 Objectives . 10
5.1.2 Source domains . 11
5.2 Measuring devices and measurement methods. 11
5.3 Levels of exposure assessment . 12
5.3.1 General . 12
5.3.2 Initial assessment – Determination of the potential for release and emission of NOAA
into the workplace air . 13
5.3.3 Basic assessment – Indication of exposure to NOAA . 14
5.3.4 Comprehensive assessment – Comprehensive characterization of the airborne
particles in the breathing zone . 18
6 Embedding of levels of exposure assessment in a tiered-approach framework . 21
6.1 General . 21
6.2 Building blocks for a tiered-approach . 22
6.3 Evaluation criteria and decision rules . 23
6.3.1 General . 23
6.3.2 Initial assessment (Tier 1) . 23
6.3.3 Basic assessment (Tier 2) . 24
6.3.4 Comprehensive assessment (Tier 3) . 26
Annex A (informative) Instruments . 27
A.1 General . 27
A.2 Real-time monitors . 27
A.2.1 General . 27
A.2.2 Aerosol photometer . 27
A.2.3 Optical Particle Counter (OPC) . 28
A.2.4 Condensation Particle Counter (CPC) . 28
A.2.5 Diffusion charger . 28
A.2.6 Differential Mobility Analysing System (DMAS) . 29
TM 2)
A.2.7 Electrical Low Pressure Impactor (ELPI ) . 29
)
TM 2
A.2.8 Tapered Element Oscillating Microbalance (TEOM ) . 29
A.3 Aerosol sampler . 29
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A.4 Off-line analysis . 30
Annex B (informative) Checklist for minimum required information during the initial
assessment . 32
Annex C (informative) Template for contextual information for comprehensive assessment
(NECID) . 34
C.1 General . 34
C.2 Structure and contents of the database . 34
Annex D (informative) Statistical analysis of time series . 36
D.1 General . 36
D.2 Statistical analysis of a size integrated time series dataset . 36
D.2.1 ARIMA . 36
D.3 Statistical analysis of size resolved time series data . 40
Annex E (informative) Decision rules for basic assessment . 42
Annex F (informative) Example for calculation of fraction deposited in the gas exchange
region . 43
F.1 General . 43
F.2 Particle size distribution. 43
F.2.1 Particle equivalent diameters . 43
F.2.2 (Number- or mass-weighted) size distributions . 45
F.2.2.1 Particle size distribution 1 . 45
F.2.2.2 Particle size distribution 2 . 45
F.3 Estimation of the fraction of particles deposited in a region of the respiratory tract. 45
F.3.1 Deposition by diffusion . 45
F.3.2 Deposition by aerodynamics . 46
F.4 Deposited dose . 47
F.5 Numerical example . 48
Bibliography . 54

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European foreword
This document (EN 17058:2018) 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 May 2019, and conflicting national standards shall be
withdrawn at the latest by May 2019.
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 has been prepared under a standardization request given to CEN by the European
Commission and the European Free Trade Association.
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
The rapidly advancing field of nanotechnologies and concern on its potential impact on occupational
health and safety has initiated efforts by Standardization bodies to provide guidance how health and
safety issues can be appropriately addressed. ISO has published a series of documents, which focus on
various aspects of exposure and risk assessment and risk mitigation, for example, ISO/TR 12885 [1],
ISO/TS 12901-1 [2], ISO/TS 12901-2 [3].
The present document focuses on the assessment of occupational exposure by inhalation of nano-
objects and their aggregates and agglomerates (NOAA). In general the objectives of an exposure
assessment can vary widely and can include exposure exploration and determination, evaluation of the
effectiveness of exposure control measures, check for compliance with any occupational exposure limit
or other benchmark level, and can contribute to risk assessment and epidemiological studies. The
measurement strategy used for the assessment will depend amongst other factors on the objective of
the assessment. ISO/TS 12901-1 for example, provides guidance for the measurement strategy for
evaluation controls. No EU legal workplace exposure limits for NOAA are established at the time of the
publication of this European Standard. However, existing non-nano OELs for many substances are in
force and these are measured as prescribed in national regulations/EN 689. Therefore, this document
concerns the elements of exposure assessment and provides guidance for various applications. In
addition, CEN has published documents (EN 16897 [4], EN 16966) that provide guidance of the use of
commonly used devices for detection of nano-sized and submicron-sized aerosols using different
metrics in the workplace air.
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1 Scope
This European Standard provides guidelines to assess workplace exposure by inhalation of nano-
objects and their aggregates and agglomerates (NOAA). It contains guidance on the sampling and
measurement strategies to adopt and methods for data evaluation.
While the focus of this document is on the assessment of nano-objects, the approach is also applicable
for exposure to the associated aggregates and agglomerates, i.e. NOAA, and particles released from
nanocomposites and nano-enabled products.
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 689:2018, Workplace atmospheres — Guidance for the assessment of exposure by inhalation to
chemical agents for comparison with limit values and measurement strategy
EN 16966:2018, Workplace exposure — Metrics to be used for the measurements of exposure to inhaled
nanoparticles (nano-objects and nanostructured materials) such as mass concentration, number
concentration and surface area concentration
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 1540, EN 16966 and the
following apply.
Note 1 to entry: With regard to EN 16966, in particular, the following terms are used in this document:
agglomerate, aggregate, BET method, nanomaterial, nano-object, nanoscale, particle aerodynamic diameter,
particle diffusive diameter, particle mobility diameter, particle and primary particle.
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
appraiser
person who is sufficiently trained and experienced in occupational hygiene principles, working and
measurement techniques, to conduct the part of the assessment he or she is performing according to
the state of the art
Note 1 to entry: The appraiser may be supported by a team of qualified persons.
[SOURCE: EN 689:2018, 3.1.1]
3.2
background measurement
background particle measurement
measurement of the particle concentration, at a location or a time not affected by the activity/process
under investigation
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[SOURCE: EN 16897:2017, 3.1, modified – The preferred term and its synonym have been taken over on
separate lines.] [4]
3.3
emission
transfer process of liberated nanomaterial or other material to the workplace air
Note 1 to entry: The emission is usually expressed as a flow, e.g. quantity as mass or number of particles per
unit time or unit area, or particle per mass of product.
3.4
exposure assessment
qualitative or quantitative determination of an employee’s exposure to a chemical or biological agent
performed by an appraiser
3.5
exposure monitoring
determination of exposure to airborne chemical and/or biological agents by using a sampling or
monitoring device for gases, vapours or airborne particles
3.6
far field
well-mixed compartment of the workspace that remains as the near field is centered on the worker
3.7
median diameter
median particle diameter
particle size of a particle distribution for which one-half the total number of particles are larger and
one-half are smaller
[SOURCE: ISO 16972:2010, 3.47] [5]
3.8
nano-activity
activity/task related to handling or processing nanomaterial
3.9
release
liberation of nanomaterial during a natural or technical process at any given lifecycle stage
Note 1 to entry: Liberation can occur in three main release forms, i.e. air dispersed (aerosols), liquid dispersed
(suspensions) and undispersed material, e.g. debris. Release can be expressed without a specific metric, as a
dispersion-specific fraction or percentage (in relation to air dispersed, liquid dispersed and undispersed) of the
total release, or as a mass per unit area or unit quantity of the matrix. Release will be dependent on the physical-
chemical properties of the nanomaterial and operational and environmental conditions.
3.10
sensitivity
true positive rate
proportion of actual positives which are correctly identified as such, and is complementary to the false
negative rate
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3.11
source domain
generation mechanism that determines particle emission characteristics for a particular life cycle stage
Note 1 to entry: Different mechanisms determine the emission rate, particle size distribution, source location
and transport of NOAA during the various life cycle stages (synthesis, downstream use, application or treatment of
products and end of life)
Note 2 to entry: The source domain can comprise similar exposure situations including the vast majority of
current and near future exposure situations [6].
[SOURCE: CEN ISO/TS 21623:2018-02, 3.17, modified – Note 2 to entry added] [7]
3.12
near field
well-mixed compartment consisting of a virtual cube with 2-m sides centred on the source of particles,
3
with volume of 8 m
Note 1 to entry: This near field space is a nominal definition and no sharp decline in concentration is envisaged
to occur at the boundary between the near field and the far field.
3.13
specificity
true negative rate
proportion of negatives which are correctly identified as such, and is complementary to the false
positive rate
4 Symbols and abbreviations
For the purposes of this document, the following symbols and abbreviations apply.
ACF Autocorrelation Function
AIC Aikaike Information Criterion
AR AutoRegressive
APS Aerodynamic Particle Sizer
ARIMA AutoRegressive Integrated Moving Average
BIC Bayesian Information Criterion
CCF Cross Correlation Function
CMD Count Median Diameter (the number-weighted median diameter)
CNF Carbon NanoFiber
CNT Carbon NanoTube
CPC Condensation Particle Counter
d Particle aerodynamic equivalent diameter
ae
d Particle diffusive equivalent diameter
de
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d Particle mobility equivalent diameter
me
d Optical diameter
opt
DC Diffusion Charger
DEMC Differential Electrical Mobility Classifier
DMAS Differential Mobility Analysing System
DR Decision Rule
DRI Direct Reading Instrument
EDS Energy Dispersive X-Ray Spectroscopy
ELPI Electrical Low Pressure Impactor
EM Electron Microscopy
EoL End of Life
ESP Electrostatic Precipitator
FF Far Field
FMPS Fast Mobility Particle Sizer
HVAC Heating, Ventilation and Air Conditioning
ICP-AES Inductively Coupled Plasma – Atomic Emission Spectroscopy
ICP-MS Inductively Coupled Plasma – Mass Spectroscopy
LSL Lower Size Limit
MA Moving Average
MNO Manufactured Nano-Object
MSDS Material Safety Data Sheet
NECID Nano Exposure and Contextual Information Database
NF Near Field
NM NanoMaterial
NOAA Nano-Objects and their Aggregates and Agglomerates
NPV Negative Predictive Value
NSAM Nanoparticle Surface Area Monitor
OECD Organisation for Economic Co-operation and Development
OEL Occupational Exposure Limit
OPC Optical Particle Counter
PACF Partial Autocorrelation Function
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PEROSH Partnership for European Research in Occupational Safety and Health
PGNP Process Generated NanoParticle
PM Particle size fraction with the aerodynamic cut-size equal to 2,5 µm
2,5
PM Particle size fraction with the aerodynamic cut-size equal to 10 µm
10
PSD Particle Size Distribution
QA Quality Assurance
QC Quality Control
R&D Research & Development
REL Recommended Exposure Limit (by NIOSH)
SD Source Domain
SEM Scanning Electron Microscopy
SMPS Scanning Mobility Particle Sizer
SOP Standard Operating Procedure
TEM Transmission Electron Microscopy
TEOM Tapered Element Oscillating Microbalance
TP Thermal Precipitator
TWA Time Weighted Average
XRD X-Ray Diffraction
XRF X-ray Fluorescence
5 Measurement strategy
5.1 General
5.1.1 Objectives
A measurement strategy for workplace exposure assessment might have a number of objectives to fulfil
including
a) determination of the substances to which exposure may take place;
b) measurement of the existing OELs for those substances in air;
c) selection of appropriate metrics and instruments to monitor exposure;
d) analysis and interpretation of the results.
The exposure measurements are part of risk assessment and the objectives can be exposure
assessment, compliance with any occupational exposure limit or benchmark level, evaluation of the
effectiveness of exposure control measures or epidemiology. The design of the actual measurement
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strategy shall be consistent with the study objectives. Exposure measurement studies that attempt to
identify exposure pathways (transport processes of the contaminant from source to the receptor (the
worker)) and exposure-modifying factors/determinants shall include both measurements at the source
as well as at the receptor, i.e. the breathing zone. Exposure assessments for use in compliance
assessment, epidemiologic studies, or risk assessment shall focus on the individual worker using
breathing zone samples collected over a full work shift or a suitable time weighted average. In contrast,
studies of the efficacy of a technical control measure may for example be carried out using static
measurements at or near the workstation or the location where the task is performed.
Depending on the objective of the assessment, the resources and the expertise, the assessment can be
performed at a specific level. The levels of exposure assessment are addressed in 5.3.
5.1.2 Source domains
For exposure assessment to NOAA, the concept of the source domains (SD) was developed [6], which
describes different processes during the lifecycle of a nanomaterial:
— During the production phase (synthesis) prior to harvesting the bulk material, point source or
fugitive emission, e.g. emissions from the reactor, leaks through seals and connections, and
incidental releases, can take place (SD1). In these cases, discrete nanoparticles and agglomerates
will be formed;
— During the manufacturing of products, the handling and transfer of bulk manufactured
nanomaterial powders with relatively low energy can release nanoparticles, e.g. collection,
harvesting, bagging, bag dumping, bag emptying, scooping, weighing, dispersion/ compounding in
composites (SD2). However, the powders are already in agglomerated stage and high shear forces
are needed for deagglomeration [8], [9]. Therefore, the majority of the released particles will be
agglomerates;
— During further processing or in the use phase of a ready-to-use nanoproduct, release can be
expected during the relatively high energy dispersion of either a) solid, powdery or (liquid)
intermediates containing highly concentrated (> 25 %) nanoparticles or b) application of
(relatively low concentrated < 5 %) ready-to-use products (SD3). Examples of SD3a are pouring,
injection molding, (jet) milling, stirring, mixing. As higher shear forces can occur during high energy
dispersion de-agglomeration can occur. Examples of SD3b are application of coatings or spraying of
solutions that can form nanosized aerosols after evaporation of the liquid phase component,
usually of mixed composition;
— During the use phase of a product or its end-of-life (EoL) phase, activities resulting in fracturing
and abrasion of manufactured nanoparticles-enabled end products at work sites, e.g. low energy
abrasion, manual sanding, or, high energy machining, e.g., sanding, grinding, drilling cutting,
shredding. High temperature processes like incineration which can occur during the EoL of a
material or product are included (SD4). Most likely it will be multi-composed aerosols, and in case
of machining also matrix-bound nanoparticles, whereas during thermal processes nanoparticles
can also be formed following nucleation and condensation of vapours [10].
Relevant contextual information achieved during the identification of a source domain will facilitate the
selection of an appropriate measurement strategy, since the source domain concept reflects different
mechanisms of release and consequently possible different nature of released aerosols, e.g. state of
agglomeration and composition.
5.2 Measuring devices and measurement methods
A range of metrics and hence measurement instruments are currently used, because there are NOAA
without a nanospecific OEL, and there is no agreed measurement metric to measure the exposure.
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Hence, exposure assessment methodologies and measurement strategies often rely on multiple metrics
and instruments, including real-time monitors and sampling devices to enable off-line analysis, in order
to conduct an adequate exposure assessment. The most commonly reported combination of real-time
and off-line instruments include direct-reading, handheld instruments (Condensation Particle Cou
...