ISO/TR TECHNICAL REPORT 12885 Second edition 2018-12 Nanotechnologies Health and safety practices in occupational settings Nanotechnologies - Pratiques de sante et de sécurité en milieux professionnels Reference number IS0/TR 12885:2018(E) @IS02018 IS0/TR 12885:2018(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2018 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior 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 CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Fax: +4122 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland i @ IS0 2018 - All rights reserved IS0/TR 12885:2018(E) Contents Page Foreword .V Introduction .vi 1 Scope. 1 2 Normative references. .1 3 Terms and definitions 1 4 Symbols and abbreviated terms 1 5 Nanomaterials: Description and manufacturing .3 5.1 Manufactured nanomaterials 3 5.2 Production processes. 5 5.2.1 Typical production processes 5 5.2.2 Aerosol generation methods 5 5.2.3 Vapor deposition methods. 5 5.2.4 Coiloidal/self-assembly methods 5 5.2.5 Electrodeposition. 6 5.2.6 Electrospinning .6 5.2.7 Attrition methods .6 6 Hazard characterization. .6 6.1 Health effects. .6 6.1.1 General 6 6.1.2 Basic principles and uncertainties .7 6.1.3 Potential relevance of health effects information about incidental or naturally-occurring NOAAs.. ..8 6.1.4 Relationship between toxicity and surface area, surface chemistry, and particle number. .8 6.1.5 Inflammatory response to NOAAs 9 6.1.6 Observations from epidemiological studies involving fine and nanoscale particles. 9 6.2 Physical hazards 10 6.2.1 Fire (exothermic events) 10 6.2.2 Safety consideration in manufacturing NOAAs 10 7 10 7.1 General 10 7.2 Scientific framework for assessing exposure to nanomaterials 12 7.2.1 Routes of exposure. 12 7.2.2 Metric for assessing exposure to airborne nanomaterials 14 7.3 Review of methods for characterizing exposure to manufactured NOAAs 17 7.3.1 General 17 7.3.2 Sampling strategy issues 20 7.4 Dustiness assessment 24 7.4.1 General. 24 7.4.2 Measurement methods .24 7.5 Dermal exposure assessment. 25 7.5.1 Sampling. 25 7.5.2 Sample characterization. 26 7.6 Dose (internal exposure) assessment 26 7.7 Discussion 26 7.8 Summary .27 8 Risk assessment in occupational settings 27 8.1 Introduction and scope. 27 8.2 Risk assessment for NOAAs 28 8.2.1 General. 28 @ IS0 2018 - All rights reserved iii IS0/TR 12885:2018(E) 8.2.2 Quantitativeandgualitativeriskassessment 28 8.2.3 Hazard identification 29 8.2.4 Exposure-response assessment. 29 8.2.5 Exposure assessment. 31 8.2.6 Risk characterization 32 8.3 Conclusions 32 9 Risk mitigation approaches .32 9.1 Introduction 32 9.2 Implication of risk assessment in regard to control methodologies 33 9.2.1 Background 33 9.2.2 Strategies for control 34 9.3 Examination of control methodologies 35 9.3.1 Exposure prevention 35 9.3.2 Controlstrategies 36 9.3.3 Reducing risk through effective design 36 9.3.4 Substitution of raw materials, products, processes and equipment 37 9.3.5 Engineering control techniques. 37 9.3.6 Administrative means for the control of workplace exposures 44 9.3.7 Evaluating the work environment 49 9.3.8 Personal protective equipment (PPE) 50 9.4 Health surveillance. 55 9.5 Product stewardship 56 Annex A (informative) Primary chemical composition of nanomaterials. 58 Annex B (informative) Nanomaterial-specific animal and cell culture toxicity studies .66 Annex C (informative) Characteristics of selected instruments and techniques for monitoring nano-aerosol exposure. .78 Annex D (informative) Characteristics of biosafety cabinets .87 Annex E (informative) Assigned protect