CEN ISO/TS 21623:2018
(Main)Workplace exposure - Assessment of dermal exposure to nano-objects and their aggregates and agglomerates (NOAA) (ISO/TS 21623:2017)
Workplace exposure - Assessment of dermal exposure to nano-objects and their aggregates and agglomerates (NOAA) (ISO/TS 21623:2017)
ISO/TS 21623:2017 describes a systematic approach to assess potential occupational risks related to nano-objects and their agglomerates and aggregates (NOAA) arising from the production and use of nanomaterials and/or nano-enabled products. This approach provides guidance to identify exposure routes, exposed body parts and potential consequences of exposure with respect to skin uptake, local effects and inadvertent ingestion.
ISO/TS 21623:2017 also considers occupational use of products containing NOAA by professionals, e.g. beauticians applying personal care products, cosmetics or pharmaceuticals, but does not apply to deliberate or prescribed exposure to these products by consumers.
ISO/TS 21623:2017 is aimed at occupational hygienists, researchers and other safety professionals to assist recognition of potential dermal exposure and its potential consequences.
Exposition am Arbeitsplatz - Leitfaden zur Beurteilung der Hautbelastung durch Nano-Objekte sowie deren Aggregate und Agglomerate (NOAA) (ISO/TS 21623:2017)
Dieses Dokument beschreibt einen systematischen Ansatz bezüglich der Bewertung möglicher Risiken am Arbeitsplatz im Hinblick auf Nanoobjekte und deren Agglomerate und Aggregate (NOAA), die sich aus der Herstellung und Nutzung von Nanomaterialien und/oder nanobasierten Produkten ergeben. Dieser Ansatz bietet Leitlinien zur Bestimmung von Expositionswegen, der Exposition ausgesetzten Körperteilen und möglichen Auswirkungen der Exposition bezüglich der Aufnahme über die Haut, lokalen Effekten und der unbeabsichtigten Aufnahme.
In diesem Dokument wird auch die Nutzung von Produkten, die NOAA enthalten, am Arbeitsplatz durch Fachleute berücksichtigt, z. B. Kosmetiker, die Körperpflegeprodukte, Kosmetika oder Pharmazeutika aufbringen; diese gilt aber nicht für die freiwillige oder verschriebene Exposition gegenüber diesen Produkten seitens der Kunden.
Dieses Dokument gilt für hauptberufliche Hygieniker, Forscher und andere Sicherheitsfachleute und dient zur Unterstützung bei der Erkennung einer möglichen Hautbelastung sowie von deren möglichen Folgen.
Exposition sur les lieux de travail - Évaluation de l'exposition cutanée aux nano-objets et à leurs agrégats et agglomérats (NOAA) (ISO/TS 21623:2017)
Izpostavljenost na delovnem mestu - Ocena dermalne izpostavljenosti nanodelcem ter njihovim agregatom in aglomeratom (NOAA) (ISO/TS 21623:2017)
Ta tehnična specifikacija CEN opisuje sistematičen pristop za ocenjevanje potencialnih poklicnih tveganj zaradi nanodelcev ter njihovih aglomeratov in agregatov (NOAA), ki nastajajo pri proizvodnji in uporabi nanomaterialov in/ali izdelkov, ki jih omogoča nanotehnologija. Ta pristop zagotavlja smernice za ugotavljanje načinov izpostavljenosti, izpostavljenih delov telesa in morebitnih posledic izpostavljenosti v povezavi z vnosom prek kože, lokalnimi učinki in nenamernim zaužitjem. Ta tehnična specifikacija upošteva tudi poklicno uporabo izdelkov za osebno nego, kozmetike in zdravil, ki jih omogoča nanotehnologija, ne zajema pa namerne ali predpisane izpostavljenosti tem izdelkom. Ta tehnična specifikacija je namenjena poklicnim higienikom, strokovnjakom s področja zdravja in varnosti ter raziskovalcem kot pomoč pri prepoznavanju in obvladovanju potencialnih tveganj.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2018
Izpostavljenost na delovnem mestu - Ocena dermalne izpostavljenosti nanodelcem
ter njihovim agregatom in aglomeratom (NOAA) (ISO/TS 21623:2017)
Workplace exposure - Assessment of dermal exposure to nano-objects and their
aggregates and agglomerates (NOAA) (ISO/TS 21623:2017)
Exposition am Arbeitsplatz - Leitfaden zur Beurteilung der Hautbelastung durch Nano-
Objekte sowie deren Aggregate und Agglomerate (NOAA) (ISO/TS 21623:2017)
Exposition sur les lieux de travail - Évaluation de l'exposition cutanée aux nano-objets et
à leurs agrégats et agglomérats (NOAA) (ISO/TS 21623:2017)
Ta slovenski standard je istoveten z: CEN ISO/TS 21623:2018
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.
CEN ISO/TS 21623
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
February 2018
TECHNISCHE SPEZIFIKATION
ICS 13.040.30
English Version
Workplace exposure - Assessment of dermal exposure to
nano-objects and their aggregates and agglomerates
(NOAA) (ISO/TS 21623:2017)
Exposition sur les lieux de travail - Évaluation de Exposition am Arbeitsplatz - Leitfaden zur Beurteilung
l'exposition cutanée aux nano-objets et à leurs agrégats der dermalen Exposition an Nano-Objekten sowie
et agglomérats (NOAA) (ISO/TS 21623:2017) deren Aggregaten und Agglomeraten (NOAA) (ISO/TS
21623:2017)
This Technical Specification (CEN/TS) was approved by CEN on 6 October 2017 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.
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. CEN ISO/TS 21623:2017 E
worldwide for CEN national Members.
Contents Page
European Foreword . 3
European Foreword
This document (CEN ISO/TS 21623:2018) has been prepared by Technical Committee ISO/TC 146 " Air
quality " in collaboration with Technical Committee CEN/TC 137 “Assessment of workplace exposure to
chemical and biological agents” the secretariat of which is held by DIN.
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.
Endorsement notice
The text of ISO 21623:2018 has been approved by CEN as CEN ISO/TS 21623:2018 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 21623
First edition
2017-11
Workplace exposure — Assessment
of dermal exposure to nano-
objects and their aggregates and
agglomerates (NOAA)
Exposition sur les lieux de travail — Évaluation de l'exposition
cutanée aux nano-objets et à leurs agrégats et agglomérats (NOAA)
Reference number
ISO/TS 21623:2017(E)
©
ISO 2017
ISO/TS 21623:2017(E)
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved
ISO/TS 21623:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Dermal exposure to NOAA — Evidence and exposure routes . 4
4.1 General . 4
4.2 Source domains . 4
4.3 Exposure routes . 5
5 Stepwise approach for assessment of dermal exposure to NOAA . 6
5.1 General . 6
5.2 Step 1: Desk evaluation . 7
5.2.1 Step 1A: Evaluation of toxicological hazard based on NOAA composition . 7
5.2.2 Step 1B: Screening for potential risks associated with dermal exposure to
insoluble (non-flexible) NOAA . 8
5.2.3 Step 1C: Screening for potential risks associated with dermal exposure
based on job title . .10
5.3 Step 2: Observation of potential for dermal exposure .11
5.4 Step 3: Additional observation of worker behaviour.11
5.5 Step 4: Quantification of NOAA .11
5.6 Step 5: Evaluation and review .12
Annex A (informative) Industries associated with use of nanomaterials or nano-
enabled products .13
Annex B (informative) How to determine skin disruption? .16
Annex C (informative) DeRmal Exposure Assessment Method (DREAM) .18
Annex D (informative) Inadvertent ingestion exposure .24
Annex E (informative) Exploring dermal exposure measurements of nanoparticles .27
Bibliography .31
ISO/TS 21623:2017(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www.iso.org/iso/foreword.html.
ISO/TS 21623 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 137, Assessment of workplace exposure to chemical and biological agents, in collaboration with
ISO Technical Committee ISO/TC 146, Air quality, Subcommittee SC 2, Workplaces atmospheres, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
iv © ISO 2017 – All rights reserved
ISO/TS 21623:2017(E)
Introduction
Dermal exposure assessment explores the dynamic interaction between environmental contaminants
and the skin. In contrast to inhalation exposure assessment, the assessment of dermal exposure
requires a different set of exposure considerations. During the last decades, the body of knowledge with
regard to dermal exposure has expanded for many types of substances, which amongst others resulted
in publications for the evaluation of dermal exposure to chemical substances that can be found, for
example, in CEN/TR 15278, CEN/TS 15279, and ISO/TR 14294.
Currently, engineered/manufactured nanomaterials and nano-enabled products are produced and
used on a wide scale. Occupational skin exposure to these substances can have biological relevance
to human health. Potential adverse effects include local skin effects, systemic toxicity following skin
absorption/uptake and inadvertent ingestion through the hand-to-mouth pathway. This document
provides guidance for the evaluation of potential dermal exposure to manufactured nano-objects, their
agglomerates and aggregates (NOAA).
This document is a compilation of the results of a pre-normative research project, executed under
Mandate M/461 for standardization activities regarding nanotechnologies and nanomaterials as issued
by the European Commission. This pre-normative research gives an overview of the mechanisms of
occupational dermal exposure to nanoparticles or nano-enabled products. This includes potential
concomitant for intake or uptake. It is based on relevant evidence of exposure for identified job
titles. Part of the pre-normative research comprised experimental work on the skin penetration
of nanoparticles, transfer of nanoparticles from a surface to the skin, and exploratory work on the
[4]-[6]
feasibility to quantify dermal exposure to NOAA .
...
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