ISO/TR 12885:2018
Nanotechnologies — Health and safety practices in occupational settings
This document describes health and safety practices in occupational settings relevant to nanotechnologies. This document focuses on the occupational manufacture and use of manufactured nano-objects, and their aggregates and agglomerates greater than 100 nm (NOAAs). It does not address health and safety issues or practices associated with NOAAs generated by natural processes, hot processes and other standard operations which unintentionally generate NOAAs, or potential consumer exposures or uses, though some of the information in this document can be relevant to those areas.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Nanomaterials: Description and manufacturing
5.1 Manufactured nanomaterials
5.2 Production processes
5.2.1 Typical production processes
5.2.2 Aerosol generation methods
5.2.3 Vapor deposition methods
5.2.4 Colloidal/self-assembly methods
5.2.5 Electrodeposition
5.2.6 Electrospinning
5.2.7 Attrition methods
6 Hazard characterization
6.1 Health effects
6.1.1 General
6.1.2 Basic principles and uncertainties
6.1.3 Potential relevance of health effects information about incidental or naturally-occurring NOAAs
6.1.4 Relationship between toxicity and surface area, surface chemistry, and particle number
6.1.5 Inflammatory response to NOAAs
6.1.6 Observations from epidemiological studies involving fine and nanoscale particles
6.2 Physical hazards
6.2.1 Fire (exothermic events)
6.2.2 Safety consideration in manufacturing NOAAs
7 Exposure assessment to nanomaterials
7.1 General
7.2 Scientific framework for assessing exposure to nanomaterials
7.2.1 Routes of exposure
7.2.2 Metric for assessing exposure to airborne nanomaterials
7.3 Review of methods for characterizing exposure to manufactured NOAAs
7.3.1 General
7.3.2 Sampling strategy issues
7.4 Dustiness assessment
7.4.1 General
7.4.2 Measurement methods
7.5 Dermal exposure assessment
7.5.1 Sampling
7.5.2 Sample characterization
7.6 Dose (internal exposure) assessment
7.7 Discussion
7.8 Summary
8 Risk assessment in occupational settings
8.1 Introduction and scope
8.2 Risk assessment for NOAAs
8.2.1 General
8.2.2 Quantitative and qualitative risk assessment
8.2.3 Hazard identification
8.2.4 Exposure-response assessment
8.2.5 Exposure assessment
8.2.6 Risk characterization
8.3 Conclusions
9 Risk mitigation approaches
9.1 Introduction
9.2 Implication of risk assessment in regard to control methodologies
9.2.1 Background
9.2.2 Strategies for control
9.3 Examination of control methodologies
9.3.1 Exposure prevention
9.3.2 Control strategies
9.3.3 Reducing risk through effective design
9.3.4 Substitution of raw materials, products, processes and equipment
9.3.5 Engineering control techniques
9.3.6 Administrative means for the control of workplace exposures
9.3.7 Evaluating the work environment
9.3.8 Personal protective equipment (PPE)
9.4 Health surveillance
9.5 Product stewardship
Annex A (informative) Primary chemical composition of nanomaterials
Annex B (informative) Nanomaterial-specific animal and cell culture toxicity studies
Annex C (informative) Characteristics of selected instruments and techniques for monitoring nano-aerosol exposure
Annex D (informative) Characteristics of biosafety cabinets
Annex E (informative) Assigned protection factors for respirators
Annex F (informative) Advantages and disadvantages of different types of air-purifying particulate respirators
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Nanomaterials: Description and manufacturing
5.1 Manufactured nanomaterials
5.2 Production processes
5.2.1 Typical production processes
5.2.2 Aerosol generation methods
5.2.3 Vapor deposition methods
5.2.4 Colloidal/self-assembly methods
5.2.5 Electrodeposition
5.2.6 Electrospinning
5.2.7 Attrition methods
6 Hazard characterization
6.1 Health effects
6.1.1 General
6.1.2 Basic principles and uncertainties
6.1.3 Potential relevance of health effects information about incidental or naturally-occurring NOAAs
6.1.4 Relationship between toxicity and surface area, surface chemistry, and particle number
6.1.5 Inflammatory response to NOAAs
6.1.6 Observations from epidemiological studies involving fine and nanoscale particles
6.2 Physical hazards
6.2.1 Fire (exothermic events)
6.2.2 Safety consideration in manufacturing NOAAs
7 Exposure assessment to nanomaterials
7.1 General
7.2 Scientific framework for assessing exposure to nanomaterials
7.2.1 Routes of exposure
7.2.2 Metric for assessing exposure to airborne nanomaterials
7.3 Review of methods for characterizing exposure to manufactured NOAAs
7.3.1 General
7.3.2 Sampling strategy issues
7.4 Dustiness assessment
7.4.1 General
7.4.2 Measurement methods
7.5 Dermal exposure assessment
7.5.1 Sampling
7.5.2 Sample characterization
7.6 Dose (internal exposure) assessment
7.7 Discussion
7.8 Summary
8 Risk assessment in occupational settings
8.1 Introduction and scope
8.2 Risk assessment for NOAAs
8.2.1 General
8.2.2 Quantitative and qualitative risk assessment
8.2.3 Hazard identification
8.2.4 Exposure-response assessment
8.2.5 Exposure assessment
8.2.6 Risk characterization
8.3 Conclusions
9 Risk mitigation approaches
9.1 Introduction
9.2 Implication of risk assessment in regard to control methodologies
9.2.1 Background
9.2.2 Strategies for control
9.3 Examination of control methodologies
9.3.1 Exposure prevention
9.3.2 Control strategies
9.3.3 Reducing risk through effective design
9.3.4 Substitution of raw materials, products, processes and equipment
9.3.5 Engineering control techniques
9.3.6 Administrative means for the control of workplace exposures
9.3.7 Evaluating the work environment
9.3.8 Personal protective equipment (PPE)
9.4 Health surveillance
9.5 Product stewardship
Annex A (informative) Primary chemical composition of nanomaterials
Annex B (informative) Nanomaterial-specific animal and cell culture toxicity studies
Annex C (informative) Characteristics of selected instruments and techniques for monitoring nano-aerosol exposure
Annex D (informative) Characteristics of biosafety cabinets
Annex E (informative) Assigned protection factors for respirators
Annex F (informative) Advantages and disadvantages of different types of air-purifying particulate respirators
Bibliography