ASTM_E_2909_-_13.pdf

Designation:E290913Standard Guide forInvestigation/Study/Assay Tab-Delimited Format forNanotechnologies(ISA-TAB-Nano):Standard File Format forthe Submission and Exchange of Data on Nanomaterialsand Characterizations1This standard is issued under the fixed designation E2909;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.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(ISA-TAB-Nano)specifies the format forrepresenting and sharing information about nanomaterials,small molecules and biological specimens along with theirassay characterization data(including metadata,and summarydata)using spreadsheet or TAB-delimited files.1.2 The Appendices Sections contain a detailed listing ofISA-TAB-Nano fields(Appendix X1),a practical example(Appendix X2),a discussion of optional files(Appendix X3),and summary of background(Appendix X4).1.3 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.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 and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ISA-TAB Format Specification:2ISA-TAB Release Candidate 1.0 ISA-TAB 1.02.2 Assay Protocol Documents from NCL:3NCL Method GTA-1(Version 1.1)LLC-PK1 Kidney Cyto-toxicity Assay2.3 Reports from NCL:4NCL200612A Dendrimer-Based MRI Contrast Agents,Pre-pared for Dendritic Nanotechnologies,Inc.December20063.Significance and Use3.1 This guide is intended to facilitate the meaningfulsubmission and exchange of nanomaterial descriptions andcharacterization data(metadata and summary data)along withthe other files(raw/derived data files,image files,protocoldocuments,etc.)among individual researchers and to or fromnanotechnology resources.This guide also serves to empowerorganizations to adopt standard methods for representing datain nanotechnology publications;and to provide researcherswith guidelines for representing nanomaterials and character-izations to achieve cross-material comparison.This guideencourages standardization in the field of informatics,whereadherence ISA-TAB-Nano concepts nanotechnology to abroader and established bioinformatics community.3.2 The format of this guide is of a file structure thatcontains four primary filesinvestigation,study,assay(ISA),and material files.3.2.1 In addition,raw or derived data files and any otherfiles(for example,image files,protocol documents)specific toeach assay can be shared along with the four primary ISA-TAB-Nano files if the data files are referenced in the primaryISA-TAB-Nano files.The specification does not provide for-mat specification for files other than the four primary files:investigation,study,assay,and material files.The ISA-TAB-Nano investigation file is used for three purposes:(1)to recordall declarative information referenced in other files;(2)to1This 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 Feb.1,2013.Published April 2013.DOI:10.1520/E2909-13.2Available from ISAtools,http:/isa-tools.org.3Available from Nanotechnology Characterization Laboratory(NCL),FrederickNational Laboratory for Cancer Research,SAIC-Frederick,Inc.,P.O.Box B,Frederick,MD 21702-1201,http:/ncl.cancer.gov.4Available from Nanotechnology Characterization Laboratory(NCL),FrederickNational Laboratory for Cancer Research,SAIC-Frederick,Inc.,P.O.Box B,Frederick,MD 21702-1201,http:/ncl.cancer.gov.Download available from http:/ncl.cancer.gov/120406.pdf.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 relate assay files to study files;and(3)to group multiple studyfiles that are part of the same investigation.The ISA-TAB-Nano study file is used to record information about the source,sampling methodology,treatment,preparation,and character-istics of the subjects(biospecimens)studied using one or moreassays under an investigation.The ISA-TAB-Nano assay filerecords the assay protocol names,endpoint measurements andreferences to image/data files;and the material file is used torepresent the composition and characteristics of nanoparticleformulations and small molecules.3.2.2 Use of Ontologies and Standard Terminologies inISA-TAB-Nano:3.2.2.1 ISA-TAB-Nano provides fields for entering andreferencing terms selected from ontologies and standard termi-nologies.The ontologies are available at BioPortal,5which ismaintained by the National Center for Biomedical Ontologies.Though the investigator may use alternative ontology andvocabulary sources,the ability