Workplace exposure - Assessment of exposure by inhalation of nano-objects and their aggregates and agglomerates

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.

Exposition am Arbeitsplatz - Beurteilung der inhalativen Exposition gegenüber Nanoobjekten und deren Aggregaten und Agglomeraten

Diese Europäische Norm bietet eine Leitlinie zur Beurteilung der Exposition durch Einatmen gegenüber Nanoobjekten und deren Aggregaten und Agglomeraten (NOAA). Sie enthält Leitlinien zu anzuwendenden Probenahme- und Messstrategien sowie Verfahren zur Datenauswertung.
Obgleich der Schwerpunkt dieses Dokuments auf der Beurteilung von Nanoobjekten liegt, gilt diese Herangehensweise auch für die Exposition gegenüber zugehörigen Aggregaten und Agglomeraten, d. h. "NOAA", sowie für Partikel, die von Nanokompositen und nanotechnologischen Produkten freigesetzt werden.

Exposition sur les lieux de travail - Évaluation de l’exposition par inhalation aux nano-objets et à leurs agrégats et agglomérats

La présente Norme européenne fournit des lignes directrices pour évaluer l’exposition par inhalation aux nano-objets et à leurs agrégats et agglomérats (NOAA) sur les lieux de travail. Elle contient des recommandations relatives aux stratégies d’échantillonnage et de mesurage à adopter, ainsi que des méthodes pour l’évaluation des données.
Bien que le présent document soit essentiellement axé sur l’évaluation des nano-objets, l’approche est également applicable à l’exposition aux agrégats et agglomérats associés, c’est-à-dire aux NOAA, et aux particules libérées des nanocomposites et des produits obtenus par nanotechnologies.

Izpostavljenost na delovnem mestu - Ocena izpostavljenosti pri vdihavanju nanopredmetov ter njihovih agregatov in aglomeratov

Ta evropski standard opisuje različne stopnje ocene izpostavljenosti pri vdihavanju nanopredmetov ter njihovih agregatov in aglomeratov (NOAA) ter vrednotenje rezultatov v obliki samostojne ocene ali vdelano v okvir večstopenjskega pristopa. Medtem ko se ta evropski standard osredotoča na oceno nanopredmetov, se pristop uporablja za izpostavljenost povezanim aglomeratom in agregatom, tj. nanopredmetom ter njihovim agregatom in aglomeratom, ter delcem, ki se sproščajo iz nanokompozitov in izdelkov, ki jih omogoča nanotehnologija.

General Information

Status
Published
Publication Date
13-Nov-2018
Withdrawal Date
30-May-2019
Current Stage

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

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.

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
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

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.
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
...

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