ISO/TR TECHNICAL REPORT 19601 First edition 2017-07 Nanotechnologies Aerosol generation for air exposure studies of nano-objects and their aggregates and agglomerates (NOAA) Nanotechnologies - Génération d'aérosols pour réaliser des études d'exposition a I'air des nano-objets et de leurs aggregats et aggloméerats (NOAA) Reference number ISO/TR 19601:2017(E) International Organization for Standardization @ IS0 2017 e=ZHEJIANG INST OF STANDARDIZATION C1 5956617 ted without license from IHS IS0/TR 19601:2017(E) COPYRIGHT PROTECTED DOCUMENT IS0 2017, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form written permission. Permission can be requested from either Iso at the address below or Iso's member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org Internatinir DrganizationforStandardization Licensee-ZHEJIANG INST.OF STANDARDIZzRoISQ7 - All rights reserved Not for Resale, 2017/9/12 03:09:22 No reproduction or networking permited without license from IHS IS0/TR 19601:2017(E) Contents Page Foreword ..V Introduction. ...vi 1 Scope. 2 Normative references 3 Terms and definitions 4 Abbreviated terms ..7 5 .8 Study design considerations 5.1 General. ..8 5.2 Workplace exposure scenario 5.3 Existing inhalation toxicity testing guidelines .9 5.4 Globally harmonized system of classification and labelling of chemicals (GHS) .9 6 Considerations in selection of proper generators. ..9 6.1 Basic scheme .9 6.1.1 Flow chart. 6.1.2 Selection of study .11 6.1.3 Characterization of physicochemical properties of nanomaterials .11 6.1.4 Exposure information on possible use or handling and manufacturing ..11 6.1.5 Exposure characteristics. .11 6.1.6 Types of inhalation exposure methods ..12 6.1.7 Particle characterization method ..12 7 NOAA aerosol generators. ..12 7.1 General .12 7.2 Dry dissemination .15 7.2.1 Wright dust feeder (see Figure 2) ..15 7.2.2 Brush type aerosol generator (see Figure 3) .16 7.2.3 Small scale powder disperser (SSPD; see Figure 4) 7.2.4 Fluidized bed aerosol generator (FBG; see Figure 5) ..18 7.2.5 Acoustic dry aerosol generator elutriator (ADAGE; see Figure 6) .19 7.2.6 Vilnius aerosol generator (VAG; see Figure Z) .20 7.2.7 Rotating drum generator (see Figure 8) .21 7.3 Wet dissemination. .23 7.3.1 Atomizer/nebulizer (see Figure 9 to Figure 11) 23 7.3.2 Electro-static assist axial atomizer (see Figure 12) 26 7.4 Phase change 27 7.4.1 Evaporation/condensation generator (see Figure 13) 27 7.4.2 Spark generator. 28 7.4.3 Condensation nano-aerosols. 29 7.5 Chemicalreaction 30 7.5.1 Combustion 30 7.6 Liquid phase filtration/dispersion - Critical point drying (tertiary butyl alcohol sublimation) and direct injection system for whole-body inhalation studies. ..32 7.6.1 Principle of operation. .32 7.6.2 Advantages. 32 7.6.3 Limitations. ..32 8 Experimental integration .36 8.1 General. 36 8.2 Exposure characterization 37 8.3 Particle properties .37 8.4 Considerations for in vivo exposure systems ..37 9 Considerations in use of nano-aerosol generator for in vitro study ..38 iii icensee=ZHEJIANG INST OF STANDARDIZATION C1 5956617 d without license from IHS