ASTM E3172-2018 Standard Guide for Reporting Production Information and Data for Nano-Objects.pdf

1、Designation: E3172 18Standard Guide forReporting Production Information and Data for Nano-Objects1This standard is issued under the fixed designation E3172; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision.

2、 A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide provides guidelines for describing the pro-duction of one or more individual nano-objects. It establishesessential and de

3、sirable information categories and descriptorsimportant to specify the production process, including thestarting materials, the process itself, and the resulting nano-objects.1.2 This guide is designed to be directly applicable toreporting production information and data for nano-objects inmost circ

4、umstances, including but not limited to reportingoriginal research results in the archival literature, developing ofontologies, database schemas, data repositories and data report-ing formats, specifying regulations, and enabling commercialactivity.1.3 This guide is applicable to an individual nano-

5、object anda collection of nano-objects.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety, health, and environmental practices and deter-mine the applicability

6、 of regulatory limitations prior to use.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World

7、 Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ISO Standards:2ISO/TS 12805:2011(en) Nanotechnologies MaterialsSpecifications Guidance on Specifying Nano-ObjectsISO/TS 80004-1:2010(en) Nanotechnologies Vocabulary Part 1: Core Terms2.2 Other Standards:Uniform

8、 Description System for Materials on the Na-noscale33. Terminology3.1 Definitions:3.1.1 For definitions of general terms used in this standard,see Compilation of ASTM Standard Definitions.43.2 Definitions of Terms for Data Description:3.2.1 descriptor, nnumerical data or text that expresses themeasu

9、rement, observation, or calculational result of someaspect of an object.3.2.1.1 DiscussionA descriptor conveys both the seman-tics of the results as well as the result itself.3.2.2 information category, na set or group of relateddescriptors that represent a property, characteristic, or featureof an

10、object.3.2.2.1 DiscussionInformation categories may be hierar-chical and contain subcategories (referred to as such), eachcontaining a set of descriptors.3.2.2.2 DiscussionInformation categories and their sub-categories are constructed to convey understanding of thestructure, properties, features, a

11、nd performance of an object.3.2.2.3 DiscussionA descriptor may occur in more thanone information category.3.2.2.4 DiscussionIt is the responsibility of the owner ofdata or information resources using an information category toensure that data and information redundancy is adequatelyaddressed.3.3 Def

12、initions of Terms for Nanomaterials:3.3.1 nanomaterial, na material with one, two, or threeexternal dimensions in the nanoscale.ISO/TS 80004-3:2010(en)3.3.2 nano-object, nan instance of nanomaterial that has adistinct physical boundary in every direction and moves freely.3.3.2.1 DiscussionA nano-obj

13、ect is the smallest unit ofnanomaterial that exists as a separate functional entity.1This guide is under the jurisdiction of ASTM Committee E56 on Nanotech-nology and is the direct responsibility of Subcommittee E56.01 on Informatics andTerminology.Current edition approved June 1, 2018. Published Ju

14、ly 2018. DOI: 10.1520/E3172-18.2Available from International Organization for Standardization (ISO), ISOCentral Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,Geneva, Switzerland, http:/www.iso.org.3Available from CODATA-VAMAS Working Group on the Description ofNanomaterials, htt

15、p:/www.codata.org/nanomaterials, as released on 25 May 2016.4Compilation of ASTM Standard Definitions, 9th edition, ASTM International,2000.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in ac

16、cordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.13.4 Definitions of Terms for

17、Production:3.4.1 production technique, na formal or informal tech-nology to produce a new substance.3.4.1.1 DiscussionExample production techniques in-clude chemical vapor deposition (CVD), arc discharge, laserablation, etc.3.4.2 recipe, na documented procedure for taking speci-fied amounts of subst

18、ances and processing them in a specifiedsequence or sequences to produce one or more new substances.3.4.2.1 DiscussionArecipe can describe how a productiontechnique can be used to produce desired nano-objects.3.4.2.2 DiscussionA recipe is often referred to as a stan-dard operating procedure.4. Summa

19、ry of Guide4.1 This guide enumerates information categories and theircontained descriptors used to report the information and datanecessary to specify the production of one or more individualnano-objects. In practice, only a subset of information catego-ries or descriptors will be used in each repor

20、t instance.4.2 Different amounts of data and information are generatedin different production scenarios. For example, production ofnew or novel nano-objects for research purposes differs fromproduction of commercial nano-objects which in turns differsfrom the production of a sample of nano-objects s

21、uitable fortoxicity testing.4.3 Nano-objects are tangible materials that are alwaysproduced from already existing tangible materials. It is desir-able in some report instances to describe the starting materialsand in other instances, only the resulting nano-objects.4.3.1 It is also desirable in many

22、 report instances simply todescribe nano-objects in detail without specifying their pro-duction process. In these instances, it is critical to ensure thatthe reported nano-objects have not been subjected to change ofany type.5. Significance and Use5.1 A nano-object at any specific time can be consid

23、eredwell-defined.5.2 The life-cycle of a nano-object can be viewed as a seriesof production processes that transforms starting materials or awell-defined nano-object into a new, equally well-definednano-object.5.3 Each step of the life-cycle can be considered a separateproduction action and can be d

24、escribed by the informationcategories and descriptors within this guide.5.4 The following are examples of nano-object productionsthat can be described by this guide.5.4.1 The creation of carbon nanotubes by arc discharge.5.4.2 The coating of a nano-object in a random or controlledmanner when placed

25、in a liquid.NOTE 1The reactivity of nano-objects makes it likely that even withthe utmost precautions, various features and characteristics may changeover time, for example, when a nano-object is placed in a liquid andcoated. Such a coating can significantly change the properties,functionalities, an

26、d reactivity of the nano-object. This change can beconsidered one step of a life-cycle and is a production process.NOTE 2A nano-object may have more than one coating. For example,titania nano-objects are often coated by alumina by manufacturers tocontrol certain properties. When these previously coa

27、ted nano-objects areplaced in liquid containing biological molecules, they can acquire asecond coating. It can require very careful administration of test proce-dures to ensure the test results can meaningfully be ascribed to charac-teristics and features of the “initial” nano-objects.5.4.3 A nano-o

28、bject experiences changes to its size, shape,physical structure, and other characteristics.NOTE 3Events such as shock (unexpected forces), temperature andpressure changes, humidity changes, shipping, dissolution, and exposureto acids and bases can result in a changed nano-object with significantlydi

29、fferent properties, functionalities, and reactivity. These events can beconsidered a production process.5.4.4 Unless care is taken to carefully control potentialchanges to a nano-object before testing, measurement resultsshould be carefully examined for unintended changes throughgood laboratory prac

30、tices, statistical analysis of all data, andverification that test samples maintain their integrity through-out the testing process.5.5 A nano-object can be subjected to a series or sequenceof production steps. The steps can be fully planned andcontrolled or some steps can happen due to random event

31、s.This guide is applicable to describe one, many, or all steps indetail.NOTE 4For example, the testing of a nano-object for potential toxiceffects may involve a sequence of steps as shown in Table 1. As can beseen, steps such as storage, insertion into biological media, or samplingcan possibly invol

32、ve random changes to the resulting nano-object.5.6 Use of this guide to describe the individual productionsteps leading to the creation of a tested nano-object can beTABLE 1 Possible Sequence of Steps in the Testing of Nano-ObjectsTest Step Nano-Object(s) State CommentsManufactured, natural, or prep

33、arednano-objectThis is the substance for which users, regulators, andothers want resultsAlmost always a collection of nano-objectsAs received In spite of precautions, changes occur during shippingand storageAgglomeration, aggregation, reactions, degradationAs prepared for testing Some processing tak

34、es place to restore the nano-object(s) to its “original” statePurification, deagglomeration, etc. to reverse shipping and storageeffectsAs sampled A subset of the nano-objects is taken for testing,hopefully fully representative of the original nano-object(s)Standard, specified, or ad hoc proceduresI

35、n the test environment Reacts with components of test media May experience reactions, additions, alterations, includingcoronas, surface modification, shape and size changes, pHchangesE3172 182important in ascertaining the cause-effect relationship betweena test result and a nano-object that was made

36、 in one of thesequence production steps prior to creation of the testednano-object.5.7 The reactivity of individual and collections of nano-objects gives rise to questions about their stability under“non-reactive” conditions such as movement, temperaturechanges, exposure to heat, and shock. These oc

37、currences arefrequent enough in the life cycle of nano-objects that additionalinformation categories and descriptors should be used asdetailed in 6.2.5.8 ISO TC 229 has produced ISO/TS 80004-1:2010(en)that defines terminology applicable to nanomanufacturing.5.9 Information on quality control with re

38、spect to theproduction process or production results is covered by ASTMand ISO quality control guides.6.1 Production:6.1.1 While the production of a nano-object in the context ofa research or experimental environment is quite different fromproduction in a commercial setting, the same informationcate

39、gories are applicable, as shown in Fig. 1.6.1.2 The amount and type information reported about theproduction of a nano-object varies greatly depending on thecircumstances as well as the source of the information.6.1.3 The basic model of the production is as follows: anano-object is produced from a s

40、et of starting materials usinga production technique, a specific recipe, and equipment undera given set of conditions. A production technique is the type ofmethod used for producing a collection, for example, mixing.The recipe specifies the starting materials and their actualamounts, the order of op

41、erations, and the conditions to be used.6.1.4 The information categories and their descriptors usedfor reporting of the production of a nano-object are given inTable 2.6.2 Stability:6.2.1 The stability of nano-objects after any productionphase is critical for understanding its characteristics,proper

42、ties, and functionalities. Once nano-objects are created,their stability is a key factor.6.2.2 The lack of stability (instability) arises primarily forthree reasons:6.2.2.1 The nano-objects are inherently unstable and willchange spontaneously.6.2.2.2 The nano-objects are subjected to unexpected con-

43、ditions such as temperature changes, violent motion, unantici-pated reactions, etc.6.2.2.3 The nano-objects are exposed to a reactive species.6.2.3 While stability can be considered as another produc-tion phase, it is useful to report information and data onstability separately. The information cate

44、gories and descriptorsthat can be used to report various aspects of the stability andinstability of nano-objects are given in Table 3.7. Keywords7.1 instability; nanomaterials; nano-object; nano-objectmanufacture; nano-object production; specification; stabilityFIG. 1 Schematic Graphic of the Produc

45、tion of a Nano-Object(s)E3172 183TABLE 2 Descriptors for the Production of a Nano-ObjectDescriptor Definition Notes and ExamplesSubcategory: Production TechniqueProduction technique name Name of production technique Not standardized, but many common techniques have widelyaccepted names; for example,

46、 chemical vapor deposition (CVD)Production purpose Reason of production For example, initial, test specimen preparation, etc.General description Description of the production technique Textual descriptionDocumentation Documentation of the production technique When it exists; for example, national or

47、 international standard;patent; etc.Source Source of the production technique For example, as described in the research literatureVariation(s) used Variations from the standard production technique Variations almost always existSubcategory: Equipment (Recurring)Equipment name Name of equipment used

48、in production For example, standard or manufacturing equipment; name givenby equipment manufacturer; etc.Equipment manufacturer Manufacturer of equipmentEquipment model Equipment model numberEquipment role Purpose of the equipmentEquipment set parameters Initial setting of equipment parameters Opera

49、ting parameters set and not changed during productionCalibration Calibration details When and how, etc.Subcategory: RecipeRecipe name Name of the recipe Identification of the recipeRecipe source Source of the recipeRecipe documentation Documentation of the recipeRecipe details Details contained in recipe Those not covered by starting materials or conditionsChanges from recipe Deviations from standard recipeSubcategory: Starting MaterialsNumber of components The number of starting materialsList of components used as startingmaterialsThe names of all starting