ASTM F2995-2013 Standard Guide for Shipping Possibly Infectious Materials Tissues and Fluids《可能具有传染性的材料 组织和流体的船运标准指南》.pdf

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1、Designation: F2995 13Standard 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

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 a general guide to transportation,including packaging and shipping of possibly infectiousmaterials, tissues, an

3、d 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 ma

4、terials.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 Thi

5、s 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

6、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, Special Provisions, Hazardous MaterialsCommunications, Eme

7、rgency 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

8、 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 Testi

9、ng29 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 Substance

10、sInfectious 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 Pac

11、kaging 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, a

12、ffecting 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 20

13、13. 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 Pri

14、nting 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, N

15、ew 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 States12.6 Un

16、ited 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 cu

17、re 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 and its

18、components, tissues,and tissue fluids, being transported for diagnostic or investiga-tional purposes, excluding live infected humans or animals.3.1.4 infectious substancea material known or suspectedto contain a pathogen.3.1.4.1 DiscussionIn older regulations and at the USPS,infectious substances ar

19、e often referred to as etiologic agents.3.1.5 pathogena virus or micro-organism (including itsviruses, plasmids, or genetic elements) with the potential tocause disease to humans or animals.3.1.6 regulated medical wastea waste or reusable materialknown or suspected to contain an infectious substance

20、 in RiskGroup 2 or 3, generated in the diagnosis, treatment, orimmunization of humans or animals, or production or testing ofbiological products.3.1.7 risk groupassigned by World Health Organization(WHO) based on severity of the disease caused by theorganisms, the mode and relative ease of transmiss

21、ion, thedegree of risk to both an individual and the community, and thereversibility of the disease through availability of known andeffective preventative agents and treatments.3.1.8 sharpsany object contaminated with a pathogen ormay be contaminated and also capable of cutting or penetratingskin o

22、r packaging material; this includes needles, syringes,scalpels, broken glass, culture slides, culture dishes, brokencapillary tubes, broken rigid plastic, and exposed ends of dentaland suture wire.3.1.9 used health care producta medical, diagnostic orresearch device, piece of equipment or implant, o

23、r a personalcare product used by consumers, medical professionals, orpharmaceutical providers that does not meet the requirementsof a diagnostic specimen, biological product, or regulatedmedical waste; this product is contaminated with potentiallyinfectious bodily fluids or materials and has not bee

24、n decon-taminated to remove or mitigate the infectious hazard prior totransportation.3.2 Definitions of Terms Specific to This Standard:3.2.1 implantany permanent or temporary device im-planted into a human.3.2.2 materialsany portion of an artificial implant.4. Classification of Dangerous Substances

25、4.1 There are a number of different regulatory agencies,each of whom has their own classifications. A summary isincluded in 4.2.4.2 General Classification Codes (outlined in DOT 49 CFR173.2):4.2.1 Class 1: Explosives:4.2.1.1 Division 1.1Mass explosive hazard.4.2.1.2 Division 1.2Projection hazard.4.2

26、.1.3 Division 1.3Mass fire hazard.4.2.1.4 Division 1.4Minor explosion hazard.4.2.1.5 Division 1.5Very insensitive explosives.4.2.1.6 Division 1.6Extremely insensitive explosives.4.2.2 Class 2: Gases:4.2.2.1 Division 2.1Flammable gases.4.2.2.2 Division 2.2Non-flammable gases.4.2.2.3 Division 2.3Poiso

27、nous or toxic.4.2.2.4 Includes compressed, dissolved under pressure, orpressurized cryogenic liquids, and liquefied gases.4.2.3 Class 3: Flammable liquidmaterial whose flashpoint is not more than 141F.4.2.4 Class 4: Flammable solids:4.2.4.1 Division 4.1Flammable solid.4.2.4.2 Division 4.2Spontaneous

28、ly combustible material.4.2.4.3 Division 4.3Dangerous when wet.4.2.5 Class 5: Oxidizing Substances; Organic Peroxides:4.2.5.1 Division 5.1Oxidizer.4.2.5.2 Division 5.2Organic peroxide.4.2.6 Class 6: Poisonous (Toxic) and Infectious Substances:4.2.6.1 Division 6.1Poisonous (toxic) material.4.2.6.2 Di

29、vision 6.2Infectious substance.4.2.7 Class 7: Radioactive Material.4.2.8 Class 8: Corrosives.4.2.9 Class 9: Miscellaneous Dangerous Goods.4.2.9.1 Includes environmentally hazardous substances, el-evated temperature materials, hazardous wastes, and marinepollutants.4.3 Infectious Substance Classifica

30、tions:4.3.1 According to IATA Packing Instructions 650, thecategories for classification of biological materials are infec-tious substances, in either Category A or Category B, diagnos-tic specimens, and biological products. Component classifica-tion can be assigned through the use of the flow chart

31、 in 7.1.Asof January 1, 2007, diagnostic specimen and biological speci-men are no longer acceptable shipping names.4.3.1.1 Infectious substances in Category A are capable ofcausing permanent disability, life threatening or fatal disease tohumans or animals when exposure occurs. They are classifiedfo

32、r shipping by their effect to humans or animals. In accor-dance with IATA Packing Instructions 650, these substancesmust be in triple packaging. The maximum quantity that can beshipped by air is 4 L or 4 kg in one package. On a passengercarrier, the amount is decreased to 50 mLor 50 g. No substancem

33、ay be carried into the cabin of the plane. The package mustdisplay a label on two opposite sides. This label must include:(1) The senders name and address,(2) The recipients name and address,(3) An infectious substance label,(4) The proper shipping name,(5) The UN number, and(6) The net quantity of

34、infectious substance.F2995 132The proper shipping names and UN identification numbersare “Infectious Substances, Affecting Humans” (UN 2814) and“Infectious Substances, Affecting Animals” (UN 2900), ac-cordingly. The name and telephone number of person respon-sible for shipment must also appear on th

35、e label of the outerpackaging, as well as a “Cargo Aircraft Only” label if thequantity for shipping is larger 50 mL or 50 g.Also, if packagedwith dry ice, a Class 9 label, including UN 1845, must beattached including the net weight of the dry ice.4.3.1.2 Category B includes substances that are infec

36、tiousbut do not meet requirements for CategoryA. For shipping, thepackage requires the identification number UN 3373 with thefollowing proper shipping names (note that the names shouldbe in all capital letters:(1) “BIOLOGICAL SUBSTANCE, CATEGORY B”;As ofJanuary 1, 2007, shipping names “Diagnostic Sp

37、ecimen” and“Clinical Specimen” will no longer be permitted. As with theCategory A substances, triple packaging is required, meetingIATA Packing Instructions 650 specifications. The maximumquantity for the primary container is 500 mL or 500 g and theouter packaging must not contain more than 4 L or 4

38、 kg. Labelsmust be displayed on two opposite sides of the outer packagingand must include the senders name and address, the recipientsname and address, the proper shipping name and UN number,and a Class 9 label, including UN 1845 and net weight, ifpackaged in dry ice. A Class 9 label is not needed w

39、hen usingIATA Packaging Instructions 602 and 650. If the substance is adiagnostic specimen or a biological product and the sourcepatient has or is suspected of having a serious disease that canbe passed from one individual to another, and for which thereare no effective preventative measures or trea

40、tments, thesesubstances must be shipped as Category A materials with anidentification number of UN 2814 or UN 2900, as appropriate.4.3.1.3 If there is doubt if a substance meets the require-ments of Category B, then it shall be listed as Category A.4.3.2 Classification according to the DOT requires

41、that thepathogen be assigned to a Risk Group (see Note 1) based on theknown medical history and condition of the source patient oranimal, the endemic local conditions, the symptoms of thesource patient or animal, or by professional judgment. TheRisk Group is assigned by the World Health Organization

42、(WHO) based on the severity of the disease caused by theorganisms, the mode and relative ease of transmission, thedegree of risk to both the individual and the community, andthe reversibility of the disease through the availability ofknown and effective preventative agents and treatments. Thereare f

43、our Risk Group categories:NOTE 1DOT no longer uses Risk Group classification.4.3.3 Risk Group 4 includes pathogens that usually causeserious disease in humans or animals. The diseases can bereadily transmitted from one individual to another, directly orindirectly, and effective treatments and preven

44、tative measuresare not usually available. There is a high risk to both theindividual and the community.4.3.4 Risk Group 3 involves pathogens that can causeserious human or animal disease but do not ordinarily spreadfrom one infected individual to another, and for which effectivetreatment and prevent

45、ative measures are available. In this case,there is a high risk to the individual but not to the community.4.3.5 Risk Group 2 pathogens can cause human or animaldisease but are unlikely to be a serious hazard, and, whilecapable of causing serious infection on exposure, for whichthere are effective t

46、reatments and preventative measures avail-able and the risk of spreading the infection is limited. The riskto the individual in this case is moderate and the risk to thecommunity is low.4.3.5.1 Risk Group 1 includes microorganisms that areunlikely to cause human or animal disease. Materials contain-

47、ing only such microorganisms are not subject to the shippingrequirements for infectious materials, since there is no or verylow risk to the individual and the community.4.3.6 Biological products, in addition to those items speci-fied earlier (3.1.1), include materials manufactured and distrib-uted i

48、n accordance with various CFR sections of the DOT.These sections cover licenses for biological products; experi-mental products, distribution, and evaluation of biologicalproducts prior to licensing; permits for biological products;investigational new drug application; applications for FDAapproval t

49、o market a new drug; and biologics. If the materialcontains pathogens in Risk Group 2, 3, or 4, it must bedescribed as an infectious substance and assigned to UN 2814or UN 2900 as appropriate, unless otherwise excepted.4.3.7 A diagnostic specimen, as defined previously (3.1.3),is not assigned a UN identification number unless the sourcepatient or animal has or may have a serious human or animaldisease from a pathogen of Risk Group 4. In this case, thematerial should be classified under Division 6.2 infectioussubstances and