ASTM F2995-2016 Standard Guide for Shipping Possibly Infectious Materials Tissues and Fluids《可能感染性物质 组织和液体运输的标准指南》.pdf

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1、Designation: F2995 16Standard 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, a

3、nd fluids that have been removed frompatients during revision surgery, at postmortem, or as part ofanimal studies, including packaging and shipping.1.2 This guide does not address any materials, tissues, orfluids that may contain prions.1.3 Individuals must be properly trained prior to shippingpossi

4、bly 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 thi

5、sstandard.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

6、 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 172.700 Purpose and ScopeDOT 49 CFR 172.101172.800 TransportationHazard-ous Materials Tab

7、le, Special Provisions, Hazardous Ma-terials Communications, Emergency ResponseInformation, Training Requirements, and Security PlansInfectious SubstancesDOT 49 CFR 173.134 TransportationShippersGeneralRequirements for Shipments and PackagingsClass 6,Division 6.2Definitions and ExceptionsDOT 49 CFR

8、173.3 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 Preparation of Packagings and Pack-age

9、s for TestingDOT 49 CFR 178.609 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

10、 (DGR). These are currently thestrictest regulations:4Packing Instructions 620 Packing InstructionsDivision6.2Category A Infectious SubstancesPacking Instructions 650 Packing InstructionsDivision6.2Category B Infectious Substances2.4 ISO Standards:5ISO 116071 Packaging for Terminally Sterilized Medi

11、calDevicesPart 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

12、 called dry iceUN 2814 Infectious substance, affecting humansUN 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 Subcommitte

13、eF04.15 on Material Test Methods.Current edition approved Nov. 15, 2016. Published January 2017. Originallyapproved in 2013. Last previous edition approved in 2013 as F2995 13. DOI:10.1520/F2995-16.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service

14、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.

15、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,

16、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 StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in th

17、e Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.12.6 United States Postal Service (USPS)3. Terminology3.1 Regulatory Definitions (from DOT 49 CFR 173.134):3.1.1 biolo

18、gical 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 culturean infectious substance containing a patho-gen that is intention

19、ally propagated; culture does not include ahuman or animal patient specimen.3.1.3 patient specimenhuman or animal material collecteddirectly from humans or animals and transported for research,diagnosis, investigational activities, or disease treatment orprevention. Patient specimen includes excreta

20、, secreta, bloodand its components, tissue and tissue swabs, body parts, andspecimens in transport media (for example, transwabs, culturemedia, and blood culture bottles).3.1.4 pathogena virus or micro-organism (including itsviruses, plasmids, or genetic elements) with the potential tocause disease

21、to humans or animals, or both.3.1.5 regulated medical wastea waste or reusable materialknown or suspected to contain an infectious substance (exceptCategory A infectious substances), generated in the diagnosis,treatment, or immunization of humans or animals or both orproduction or testing of biologi

22、cal products.3.1.6 risk groupterm assigned by World Health Organiza-tion (WHO) based on the severity of the disease caused by theorganisms, the mode and relative ease of transmission, thedegree of risk to both an individual and the community, and thereversibility of the disease through availability

23、of known andeffective preventative agents and treatments.3.1.7 sharpsany object contaminated or potentially con-taminated with a pathogen and capable of cutting and capableof cutting or penetrating skin or packaging material; thisincludes needles, syringes, scalpels, broken glass, cultureslides, cul

24、ture dishes, broken capillary tubes, broken rigidplastic, and exposed ends of dental and suture wire.3.1.8 used health care producta medical, diagnostic orresearch device, piece of equipment or implant, or a personalcare product used by consumers, medical professionals, orpharmaceutical providers th

25、at 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 been decon-taminated to remove or mitigate the infectious hazard prior totransportation.3.2 Definit

26、ions 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 Substances4.1 There are a number of different regulatory agencies,each of whom has their own classificatio

27、ns. A summary isincluded in 4.2.4.2 General Classification Codes (outlined in DOT 49 CFR173.3):4.2.1 Class 1: Explosives:4.2.1.1 Division 1.1Mass explosive hazard.4.2.1.2 Division 1.2Projection hazard.4.2.1.3 Division 1.3Mass fire hazard.4.2.1.4 Division 1.4Minor explosion hazard.4.2.1.5 Division 1.

28、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 2.3Poisonous or toxic.4.2.2.4 Includes compressed, dissolved under pressure, orpressurized cryogenic liq

29、uids, 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 4.2Spontaneously combustible material.4.2.4.3 Division 4.3Dangerous when wet.4.2.5 Class 5: Oxidizing Substanc

30、es; 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 Division 6.2Infectious substance.4.2.7 Class 7: Radioactive Material.4.2.8 Class 8: Corrosives.4.2

31、.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 Classifications:4.3.1 According to IATA 3.6.2.2, the categories for classi-fication of biological material

32、s are infectious substances, ineither CategoryAor Category B, exempting patient specimens,and biological products. Component classification can beassigned through the use of the flow charts in 7.1.4.3.1.1 Infectious substances in Category A are in a formcapable of causing permanent disability, life-

33、threatening orfatal disease to otherwise healthy humans or animals whenexposure to it occurs. They are classified for shipping by theireffect on humans or animals. In accordance with IATAPackingInstructions 620, these substances must be in triple packaging.The maximum quantity that can be shipped by

34、 air is 4 L or 4kg in one package. On a passenger carrier, the amount isdecreased to 50 mL or 50 g. No infectious substance may becarried into the cabin of the plane. The package must displaythe following marks and labels:(1) The senders name and address,(2) The recipients name and address,(3) An in

35、fectious substance hazard label,(4) The proper shipping name,(5) The UN number, and(6) The net quantity of infectious substance (only requiredif other dangerous goods are in the same package).F2995 162The proper shipping names and UN identification numbersare “Infectious Substances, Affecting Humans

36、” (UN 2814) and“Infectious Substances, Affecting Animals” (UN 2900), ac-cordingly. The name and telephone number of the personresponsible for shipment must also appear on the label of theouter packaging, as well as a “Cargo Aircraft Only” label if thequantity for shipping is greater than 50 mL or 50

37、 g. Also, ifpackaged with dry ice, a Class 9 label, including UN 1845 anddry ice (or carbon dioxide, solid), must be attached, includingthe net weight of the dry ice.4.3.1.2 Category B includes substances that are infectiousbut do not meet requirements for CategoryA. For shipping, thepackage require

38、s the identification of the proper shipping nameand the UN 3373 with the following.(1) Biological Substance, Category B. As with the Cat-egoryAsubstances, triple packaging is required, meeting IATAPacking Instructions 650 specifications. The maximum quan-tity for the primary container is 1 mL or 4 k

39、g and the outerpackaging must not contain more than 4 L or 4 kg. Labels mustbe displayed on the outer packaging and must include thesenders name and address, the recipients name and address,the proper shipping name and the UN 3373 diamond marking.For shipments with dry ice a Class 9 label, including

40、 UN 1845and the proper shipping name dry ice (or carbon dioxide, solid)and the net weight of the dry ice. If the substance is adiagnostic specimen or a biological product and the sourcepatient has or is suspected of being infected with a Category Ainfectious substance, these substances must be shipp

41、ed asCategory A materials with the UN number of UN 2814 or UN2900, as appropriate.4.3.1.3 If there is doubt as to whether or not a substancemeets the requirements of Category B, then it shall be listed asCategory A.4.3.2 Biological products, in addition to those items speci-fied earlier (3.1.1), inc

42、lude materials manufactured and distrib-uted in 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 dr

43、ug application; applications for FDAapproval to 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 2814,UN 2900, or UN 3373, as appropriate, unless otherwiseexcepted.4.3.3 A patient specimen,

44、 as defined previously (3.1.3), isclassified as a Category B infectious substance unless thesuspected pathogen meets the requirements of a Category Ainfectious substance. In this case, the material should beclassified as a Category A infectious substance and assigned toUN 2814 or UN 2900, as appropr

45、iate.4.3.4 Regulated medical waste containing a Category Ainfectious substance must be classified as a Category Ainfectious substance, and assigned the appropriate UN identi-fication number.4.3.5 The following exceptions are not subject to the re-quirements of Division 6.2:4.3.5.1 A biological or di

46、agnostic product containing patho-gens where the pathogen has been neutralized or inactivated soit cannot cause disease when exposure occurs. This also appliesto biological products, including an experimental product orcomponent of a product, subject to federal approval, permit orlicensing requireme

47、nts, such as those required by the Food andDrug Administration, the Department of Health and HumanServices or the US Department of Agriculture.4.3.5.2 Blood collected for transfusion or preparation ofblood products; blood products, tissues or organs for trans-plant; human cells, tissues, and cellula

48、r and tissue-basedproducts regulated under the Public Health Service Act and/orthe Food, Drug and Cosmetic Act, unless suspected of contain-ing a pathogen.4.3.5.3 Corpses, remains, and anatomical parts intended forinterment, cremation, or medical research.4.3.5.4 A non-Category A patient specimen tr

49、ansported in aprivate or contracted vehicle used exclusively for that purpose.4.3.5.5 Laundry or medical equipment conforming to regu-lations 29 CFR part 1910.1030. This includes equipment thatwill be cleaned, refurbished, and used, but not medical equip-ment disposal.4.3.5.6 Material, including waste, that has been sterilized ordisinfected, by steam, chemicals, or other appropriatemeasures, so it no longer meets requirements for infectioussubstance.4.3.5.7 Any waste or recyclable, other than regulated medi-cal waste, includ