1、BSI Standards Publication PD ISO/TS 12901-2:2014 Nanotechnologies Occupational risk management applied to engineered nanomaterials Part 2: Use of the control banding approachPD ISO/TS 12901-2:2014 PUBLISHED DOCUMENT National foreword This Published Document is the UK implementation of ISO/TS 12901-2
2、:2014. The UK participation in its preparation was entrusted to Technical Committee NTI/1, Nanotechnologies. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Use
3、rs are responsible for its correct application. The British Standards Institution 2014. Published by BSI Standards Limited 2014 ISBN 978 0 580 68368 8 ICS 07.030; 13.100 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the
4、authority of the Standards Policy and Strategy Committee on 28 February 2014. Amendments issued since publication Date Text affectedPD ISO/TS 12901-2:2014 ISO 2014 Nanotechnologies Occupational risk management applied to engineered nanomaterials Part 2: Use of the control banding approach Nanotechno
5、logies Gestion du risque professionnel applique aux nanomatriaux manufacturs Partie 2: Utilisation de lapproche par bandes de dangers TECHNICAL SPECIFICATION ISO/TS 12901-2 First edition 2014-01-15 Reference number ISO/TS 12901-2:2014(E)PD ISO/TS 12901-2:2014ISO/TS 12901-2:2014(E)ii ISO 2014 All rig
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8、erlandPD ISO/TS 12901-2:2014ISO/TS 12901-2:2014(E) ISO 2014 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 4 Symbols and abbreviated terms . 4 5 General framework for control banding applied to NOAA 4 5.1 General . 4
9、 5.2 Information gathering and data recording . 5 5.3 Hazard banding 6 5.4 Exposure banding . 6 5.5 Control banding 6 5.6 Review and data recording . 7 6 Information gathering 7 6.1 NOAA characterization . 7 6.2 Exposure characterization 8 6.3 Characterization of control measures . 9 7 Control bandi
10、ng implementation 10 7.1 Preliminary remarks .10 7.2 Hazard band setting.10 7.3 Exposure band setting .16 7.4 Control band setting and control strategies .20 7.5 Evaluation of controls 21 7.6 Retroactive approach Risk banding 22 8 Performance, review and continual improvement 24 8.1 General 24 8.2 O
11、bjectives and performance .24 8.3 Data recording 24 8.4 Management review 25 Annex A (informative) Exposure algorithm in the Stoffenmanager risk banding approach 26 Annex B (informative) Health hazard class according to GHS .29 Bibliography .30PD ISO/TS 12901-2:2014ISO/TS 12901-2:2014(E) Foreword IS
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18、committee responsible for this document is ISO/TC 229, Nanotechnologies. ISO/TS 12901 consists of the following parts, under the general title Nanotechnologies Occupational risk management applied to engineered nanomaterials: Part 1: Principles and approaches Part 2: Use of the control banding appro
19、achiv ISO 2014 All rights reservedPD ISO/TS 12901-2:2014ISO/TS 12901-2:2014(E) Introduction According to the current state of knowledge, nano-objects, and their aggregates and agglomerates greater than 100 nm (NOAA) can exhibit properties, including toxicological properties, which are different from
20、 those of non-nanoscale (bulk) material. Therefore, current occupational exposure limits (OELs), which are mostly established for bulk materials might not be appropriate for NOAA. In the absence of relevant regulatory specifications for NOAA, the control banding approach can be used as a first appro
21、ach to controlling workplace exposure to NOAA. NOTE 1 Aggregates and agglomerates smaller than 100 nm are to be considered as nano-objects. Control banding is a pragmatic approach which can be used for the control of workplace exposure to possibly hazardous agents with unknown or uncertain toxicolog
22、ical properties and for which quantitative exposure estimations are lacking. It may complement the traditional quantitative methods based on air sampling and analysis with reference to OELs when they exist. It can provide an alternative risk assessment and risk management process, by grouping occupa
23、tional settings in categories presenting similarities of hazards and/or exposure, while incorporating professional judgment and monitoring. This process applies a range of control techniques (such as general ventilation or containment) to a specific chemical, considering its range (or band) of hazar
24、d and the range (or band) of exposure. In general, control banding is based on the idea that while workers can be exposed to a diversity of chemicals, implying a diversity in risks, the number of common approaches to risk control is limited. These approaches are grouped into levels based on how much
25、 protection the approach offers (with “stringent” controls being the most protective). The greater the potential for harm, the greater the levels of protection needed for exposure control. Control banding was originally developed by the pharmaceutical industry as a way to safely work with new chemic
26、als that had little or no toxicity information. These new chemicals were classified into “bands” based on the toxicity of analogous and better known chemicals and were linked to anticipated safe work practices, taking into consideration exposure assessments. Each band was then aligned with a control
27、 scheme. 1Following this concept, the Health and Safety Executive (HSE) in the UK has developed a user-friendly scheme called COSHH Essentials, 234primarily for the benefit of small- and medium- sized enterprises that might not benefit from the expertise of a resident occupational hygienist. Similar
28、 schemes are used in the practical guidance given by the German Federal Institute for Occupational Safety and Health. 5The Stoffenmanager Tool 6represents a further development, combining a hazard banding scheme similar to that of COSHH Essentials and an exposure banding scheme based on an exposure
29、process model, which was customized in order to allow non-expert users to understand and use the model. Control banding can be particularly useful for the risk assessment and management of nanomaterials, given the level of uncertainty in work-related potential health risks from NOAA. It may be used
30、for risk management in a proactive manner and in a retroactive manner. In the proactive manner existing control measures, if any, are not used as input variables in the potential exposure banding while in a retroactive manner existing control measures are used as input variables. Both approaches are
31、 described in this part of ISO/TS 12901. While control banding appears, in theory, to be appropriate for nanoscale materials exposure control, very few comprehensive tools are currently available for ongoing nanotechnology operations. A conceptual control banding model was presented by Maynard 7offe
32、ring the same four control approaches as COSHH. A slightly different approach, called “Control Banding Nanotool”, was presented by Paik et al. 89This approach takes into account existing knowledge of NOAA toxicology and uses the control banding framework proposed in earlier publications. However, th
33、e ranges of values used in the “Control Banding Nanotool” correspond to those ranges that one would expect in small-scale research type operations (less than one gram) and might not seem appropriate for larger scale uses. In the meantime several other specific control banding tools have been publish
34、ed to control inhalation exposure to engineered nanomaterials for larger scale uses. 1011121314All these tools define hazard bands and exposure bands for inhalatory exposure and combine these in a two- dimensional matrix, resulting in a score for risk control (proactive approach). Schneider et al. 1
35、5have developed a conceptual model for assessment of inhalation exposure to engineered nanomaterials, suggesting a general framework for future exposure models. This framework follows ISO 2014 All rights reserved vPD ISO/TS 12901-2:2014ISO/TS 12901-2:2014(E) the same structure as the conceptual mode
36、l for inhalation exposure used in the Stoffenmanager Tool and the Advanced REACH Tool (ART). 61617Based on this conceptual framework, a control banding tool called “Stoffenmanager Nano” has been developed, 18encompassing both proactive approach and retroactive (risk banding) approach. In addition, t
37、he French agency for food, environmental and occupational health and safety (ANSES) have developed a control banding tool specifically for nanomaterials which is described in the report “Development of a specific control banding tool for nanomaterials” 31 . The biggest challenge in developing any co
38、ntrol banding approach for NOAA is to decide which parameters are to be considered and what criteria are relevant to assign a nano-object to a control band, and what operational control strategies ought to be implemented at different operational levels. This part of ISO/TS 12901 proposes guidelines
39、for controlling and managing occupational risk based on a control banding approach specifically designed for NOAA. It is the responsibility of manufacturers and importers to determine whether a material of concern contains NOAA, and to provide relevant information in safety data sheets (SDS) and lab
40、els, in compliance with any national or international existing regulation. Employers can use this information to identify hazards and implement appropriate controls. This part of ISO/TS 12901 does not intend to give recommendations on this decision-making process. It cannot replace regulation and em
41、ployers are expected to comply with the existing regulations. It is emphasized that the control banding method applied to manufactured NOAA requires assumptions to be formulated on information that is desirable but unavailable. Thus the user of the control banding tool needs to have proven skills in
42、 chemical risk prevention and more specifically in risk issues known to be related to that type of material. The successful implementation of this approach requires a solid expertise combined with a capacity for critical evaluation of potential occupational exposures and training to use control band
43、ing tools to ensure appropriate control measures and an adequately conservative approach. In parallel to the approach described in this part of ISO/TS 12901, a full hazard assessment is advisable to consider all substance-related hazards, including explosive risk (see NOTE 2), and environmental haza
44、rds. NOTE 2 Explosive dust clouds can be generated from most organic materials, many metals and even some non- metallic inorganic materials. The primary factor influencing the ignition sensitivity and explosive violence of a dust cloud is the particle size or specific surface area (i.e. the total su
45、rface area per unit volume or unit mass of the dust) and the particle composition. As the particle size decreases the specific surface area increases. The general trend is for the violence of the dust explosion and the ease of ignition to increase as the particle size decreases, though for many dust
46、s this trend begins to level out at particle sizes of the order of tens of micrometres (m). However, no lower particle size limit has been established below which dust explosions cannot occur and it has to be considered that many nanoparticle types have the potential to cause explosions.vi ISO 2014
47、All rights reservedPD ISO/TS 12901-2:2014TECHNICAL SPECIFICATION ISO/TS 12901-2:2014(E) Nanotechnologies Occupational risk management applied to engineered nanomaterials Part 2: Use of the control banding approach 1 Scope The purpose of this part of ISO/TS 12901 is to describe the use of a control b
48、anding approach for controlling the risks associated with occupational exposures to nano-objects, and their aggregates and agglomerates greater than 100 nm (NOAA), even if knowledge regarding their toxicity and quantitative exposure estimations is limited or lacking. The ultimate purpose of control
49、banding is to control exposure in order to prevent any possible adverse effects on workers health. The control banding tool described here is specifically designed for inhalation control. Some guidance for skin and eye protection is given in ISO/TS 12901-1. 19 This part of ISO/TS 12901 is focused on intentionally produced NOAA that consist of nano-objects such as nanoparticles, nanopowders, nanofibres, nanotubes, nanowires, as well as of aggregates and agglomerates of the same. As used in this p
