EN ISO TS 21623-2018 en Workplace exposure - Assessment of dermal exposure to nano-objects and their aggregates and agglomerates.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Workplace exposure Assessment of dermal exposure to nano-objects and their aggregates and agglomerates (NOAA) (ISO/TS 21623:2017)PD CEN ISO/TS 21623:2018National forewordThis Published Document is the UK implementation

2、of CEN ISO/TS 21623:2018. It is identical to ISO/TS 21623:2017.The UK participation in its preparation was entrusted to Technical Committee EH/2/2, Work place atmospheres.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purpo

3、rt to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 95729 1ICS 13.040.30Compliance with a British Standard cannot confer immunity from legal obligatio

4、ns. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 March 2018.Amendments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD CEN ISO/TS 21623:2018TECHNICAL SPECIFICATIONSPCIFICATION TECHNIQUETECHNISCHE SPEZIFIKATIO

5、NCEN ISO/TS 21623February 2018ICS 13.040.30EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. CEN ISO/TS 21623:2018: EAll rights of exploitation in any form and by any me

6、ans reserved worldwide for CEN national MembersWorkplace exposure - Assessment of dermal exposure to nano-objects and their aggregates and agglomerates (NOAA) (ISO/TS 21623:2017)Exposition sur les lieux de travail - valuation de lexposition cutane aux nano-objets et leurs agrgats et agglomrats (NOAA

7、) (ISO/TS 21623:2017)Exposition am Arbeitsplatz - Leitfaden zur Beurteilung der dermalen Exposition an Nano-Objekten sowie 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

8、 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

9、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 m

10、embers 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, Por

11、tugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionCEN ISO/TS 21623:2018 (E)European ForewordThis document (CEN ISO/TS 21623:2018) has been prepared by Technical Committee ISO/TC 146 “ Air quality “ in collaboration with Technical Committ

12、ee 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 al

13、l such patent rights.Endorsement noticeThe text of ISO 21623:2018 has been approved by CEN as CEN ISO/TS 21623:2018 without any modification.2PD CEN ISO/TS 21623:2018ISO/TS 21623:2017Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Dermal exposure to NOAA Evid

14、ence and exposure routes 44.1 General . 44.2 Source domains 44.3 Exposure routes . 55 Stepwise approach for assessment of dermal exposure to NOAA . 65.1 General . 65.2 Step 1: Desk evaluation 75.2.1 Step 1A: Evaluation of toxicological hazard based on NOAA composition 75.2.2 Step 1B: Screening for p

15、otential risks associated with dermal exposure to insoluble (non-flexible) NOAA . 85.2.3 Step 1C: Screening for potential risks associated with dermal exposure based on job title .105.3 Step 2: Observation of potential for dermal exposure .115.4 Step 3: Additional observation of worker behaviour115.

16、5 Step 4: Quantification of NOAA 115.6 Step 5: Evaluation and review 12Annex A (informative) Industries associated with use of nanomaterials or nano-enabled products 13Annex B (informative) How to determine skin disruption? 16Annex C (informative) DeRmal Exposure Assessment Method (DREAM) .18Annex D

17、 (informative) Inadvertent ingestion exposure .24Annex E (informative) Exploring dermal exposure measurements of nanoparticles 27Bibliography .31 ISO 2017 All rights reserved iiiContents PagePD CEN ISO/TS 21623:2018ISO/TS 21623:2017ForewordISO (the International Organization for Standardization) is

18、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 represent

19、ed 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 t

20、his 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

21、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 de

22、velopment 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 nat

23、ure of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs 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 2162

24、3 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

25、the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).iv ISO 2017 All rights reservedPD CEN ISO/TS 21623:2018ISO/TS 21623:2017IntroductionDermal exposure assessment explores the dynamic interaction between environmental contaminants and the skin. In contrast to inhalation exp

26、osure 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

27、 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 releva

28、nce 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, the

29、ir 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

30、 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 t

31、he skin penetration of nanoparticles, transfer of nanoparticles from a surface to the skin, and exploratory work on the feasibility to quantify dermal exposure to NOAA4-6. ISO 2017 All rights reserved vPD CEN ISO/TS 21623:2018This page deliberately left blankWorkplace exposure Assessment of dermal e

32、xposure to nano-objects and their aggregates and agglomerates (NOAA) (ISO/TS 21623:2017)1 ScopeThis document 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 nanomaterial

33、s 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.This document also considers occupational use of products containing NOAA by pro

34、fessionals, e.g. beauticians applying personal care products, cosmetics or pharmaceuticals, but does not apply to deliberate or prescribed exposure to these products by consumers.This document is aimed at occupational hygienists, researchers and other safety professionals to assist recognition of po

35、tential dermal exposure and its potential consequences.2 Normative referencesThe 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, th

36、e latest edition of the referenced document (including any amendments) applies.EN 1540, Workplace exposure TerminologyISO 18158, Workplace air Terminology3 Terms and definitionsFor the purposes of this document, the terms and definitions given in EN 1540, ISO 18158 and the following apply.ISO and IE

37、C 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 3.1agglomeratecollection of weakly or medium strongly bound particles where the resu

38、lting external surface area is similar to the sum of the surface areas of the individual componentsNote 1 to entry: The forces holding an agglomerate together are weak forces, for example, van der Waals forces or simple physical entanglement.Note 2 to entry: Agglomerates are also termed secondary pa

39、rticles and the original source particles are termed primary particles.SOURCE: ISO/TS 80004-2:2015, 3.4TECHNICAL SPECIFICATION ISO/TS 21623:2017 ISO 2017 All rights reserved 1PD CEN ISO/TS 21623:2018ISO/TS 21623:20173.2aggregateparticle comprising strongly bonded or fused particles where the resulti

40、ng external surface area is significantly smaller than the sum of surface areas of the individual componentsNote 1 to entry: The forces holding an aggregate together are strong forces, for example, covalent or ionic bonds or those resulting from sintering or complex physical entanglement, or otherwi

41、se combined former primary particles.Note 2 to entry: Aggregates are also termed secondary particles and the original source particles are termed primary particles.SOURCE: ISO/TS 80004-2:2015, 3.53.3dermal contact volumevolume containing the mass of the agent that contacts the dermal exposure surfac

42、e (3.7) Note 1 to entry: This is equivalent to the volume of the skin contaminant layer and for practical reasons represents the volume of the compartment where the mass of the substance is all contained.SOURCE: CEN/TR 15278:2006, 2.2, modified Note 1 adapted3.4dermal exposure concentrationdermal ex

43、posure mass (3.6) divided by the dermal contact volume (3.3) or the dermal exposure mass divided by the mass contained in the skin contaminant layerNote 1 to entry: Dermal exposure concentration is expressed in g/l or g/kg or other appropriate units as necessary.SOURCE: CEN/TR 15278:2006, 2.4, modif

44、ied Note 1 adapted3.5dermal exposure loadingdermal exposure mass (3.6) divided by the dermal exposure surface (3.7) areaNote 1 to entry: For practical reasons, it can be expressed as mass of agent in an exposed part of the skin contaminant layer divided by the surface area of that part.SOURCE: CEN/T

45、R 15278:2006, 2.53.6dermal exposure massmass of agent present in the dermal contact volume (3.3) Note 1 to entry: For practical reasons, it is defined by the amount of agent in g present in the skin contaminant layer, or other appropriate units as necessary.Note 2 to entry: The outcome of the proces

46、s of dermal exposure, i.e. the contact, can be expressed by different parameters of exposure.SOURCE: CEN/TR 15278:2006, 2.6, modified Note 1 adapted3.7dermal exposure surfaceskin surface area where an agent is presentNote 1 to entry: For practical reasons, this is represented by a two-dimensional re

47、presentation of the skin contaminant layer in cm2.SOURCE: CEN/TR 15278:2006, 2.72 ISO 2017 All rights reservedPD CEN ISO/TS 21623:2018ISO/TS 21623:20173.8nanocompositesolid comprising a mixture of two or more phase-separated materials, one or more being nanophase (3.13) Note 1 to entry: Gaseous nano

48、phases are excluded.Note 2 to entry: Materials with nanoscale phases formed by precipitation alone are not considered to be nanocomposite materials.SOURCE: ISO/TS 80004-4:2011, 3.23.9nano-enabledexhibiting function or performance only possible with nanotechnologyNote 1 to entry: Potential release of

49、 NOAA from nano-enabled products is considered relevant in view of dermal exposure assessment.SOURCE: ISO/TS 80004-1:2015, 2.15, modified Note 1 added3.10nanomaterialmaterial with any external dimensions in the nanoscale or having internal structure or surface structure in the nanoscale (3.14) SOURCE: ISO/TS 80004-1:2015, 2.4, modified Notes 1 and 2 deleted3.11nano-objectdiscrete piece of material with one, two or three external dimensions in the nanoscale (3.14) Note 1 to entry: The second and third external di