ASTM_F_2995_-_13.pdf

Designation:F299513Standard Guide forShipping Possibly Infectious Materials,Tissues,and Fluids1This standard is issued under the fixed designation F2995;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 provides a general guide to transportation,including packaging and shipping of possibly infectiousmaterials,tissues,and fluids that have been removed frompatients during revision surgery,at postmortem,or as part ofanimal studies.1.2 This guide does not address any materials,tissues,orfluids that may contain prions.1.3 It is recommended that individuals be properly trainedprior to shipping possibly infectious materials.1.4 This guide is a compilation of national and internationalregulations and guidelines that apply to the packaging andshipment of possibly infectious materials.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 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.Some specifichazards statements are given in Section 7 on Hazards.2.Referenced Documents2.1 ASTM Standards:2D4840 Guide for Sample Chain-of-Custody Procedures2.2 Federal Standards and Regulatory Bodies:3DOT 49 CFR 172.323 TransportationHazardous MaterialsTable,SpecialProvisions,HazardousMaterialsCommunications,Emergency Response Information,Training Requirements,and Security PlansInfectiousSubstancesDOT 49 CFR 173.134 TransportationShippersGeneralRequirements for Shipments and PackagingsClass 6,Division 6.2Definitions and ExceptionsDOT 49 CFR 173.2 TransportationShippersGeneralRequirements for Shipments and PackagingsHazardousMaterials Classes and Index to Hazard Class DefinitionsDOT 49 CFR 178 TransportationOther Regulations Relat-ing to TransportationSpecifications for PackagingsDOT 49 CFR 178.602 TransportationTesting of Non-BulkPackagings and PackagesPreparation of Packagings andPackages for Testing29 CFR Part 1910.1030 Occupational Safety and HealthStandardsBloodborne Pathogens2.3 International Air Transport Association(IATA)usesDangerous Goods Regulations(DGR).These are currently thestrictest regulations:4Packing Instructions 602 Packing InstructionsClass6Toxic and Infectious SubstancesInfectious Sub-stancePacking Instructions 650 Packing InstructionsClass6Toxic and Infectious SubstancesDiagnostic Speci-men2.4 ISO Standards:5ISO 116071 Packaging for Terminally Sterilized MedicalDevicesPart 1:Requirements for Materials,Sterile Bar-rier Systems and Packaging SystemsISO 116072 Packaging for Terminally Sterilized MedicalDevicesPart 2:Validation Requirements for Forming,Sealing and Assembly Processes2.5 UN Dangerous Transport Standards:6UN 1845 Carbon dioxide,solid,also called dry iceUN 2814 Infectious substance,affecting humans(RiskGroup 2)UN 2900 Infectious substance,affecting animalsUN 3373 Biological substance,Category B1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved March 1,2013.Published August 2013.DOI:10.1520/F2995-13.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from U.S.Government Printing Office Superintendent of Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Washington,DC 20401,http:/www.access.gpo.gov.4Available from International Air Transport Association(IATA),http:/www.iata.org.5Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.6Available from United Nations Economic Commission for Europe(UNECE),Palais des Nations,CH-1211 Geneva 10,Switzerland,http:/www.unece.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 2.6 United States Postal Service(USPS).3.Terminology3.1 Regulatory Definitions(from DOT 49 CFR 173.134):3.1.1 biological producta virus,therapeutic serum,toxin,antitoxin,vaccine,blood,blood component or derivative,tissue,allergenic product,or analogous product used fordiagnosis,treatment,or cure of diseases in human or animals.3.1.2 cultures and stocksmaterials prepared and main-tained for the growth and storage of pathogens,and contain aRisk Group 2,3,or 4 infectious substance(see 4.3.2).3.1.3 diagnostic specimenany human or animal material,including excreta,secreta,blood an