ASTM F2995-13
(Guide)Standard Guide for Shipping Possibly Infectious Materials, Tissues, and Fluids
Standard Guide for Shipping Possibly Infectious Materials, Tissues, and Fluids
SCOPE
1.1 This guide provides a general guide to transportation, including packaging and shipping of possibly infectious materials, tissues, and fluids that have been removed from patients during revision surgery, at postmortem, or as part of animal studies.
1.2 This guide does not address any materials, tissues, or fluids that may contain prions.
1.3 It is recommended that individuals be properly trained prior to shipping possibly infectious materials.
1.4 This guide is a compilation of national and international regulations and guidelines that apply to the packaging and shipment of possibly infectious materials.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Some specific hazards statements are given in Section 7 on Hazards.
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Designation: F2995 − 13
Standard Guide for
Shipping Possibly Infectious Materials, Tissues, and Fluids
This standard is issued under the fixed designation F2995; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope Training Requirements, and Security Plans—Infectious
Substances
1.1 This guide provides a general guide to transportation,
DOT 49 CFR 173.134 Transportation—Shippers—General
including packaging and shipping of possibly infectious
Requirements for Shipments and Packagings—Class 6,
materials, tissues, and fluids that have been removed from
Division 6.2—Definitions and Exceptions
patients during revision surgery, at postmortem, or as part of
DOT 49 CFR 173.2 Transportation—Shippers—General
animal studies.
Requirements for Shipments and Packagings—Hazardous
1.2 This guide does not address any materials, tissues, or
Materials Classes and Index to Hazard Class Definitions
fluids that may contain prions.
DOT49 CFR 178 Transportation—Other Regulations Relat-
ing to Transportation—Specifications for Packagings
1.3 It is recommended that individuals be properly trained
prior to shipping possibly infectious materials. DOT49 CFR 178.602 Transportation—Testing of Non-Bulk
PackagingsandPackages—PreparationofPackagingsand
1.4 This guide is a compilation of national and international
Packages for Testing
regulations and guidelines that apply to the packaging and
29 CFR Part 1910.1030 Occupational Safety and Health
shipment of possibly infectious materials.
Standards—Bloodborne Pathogens
1.5 The values stated in SI units are to be regarded as
2.3 International Air Transport Association (IATA) uses
standard. No other units of measurement are included in this
Dangerous Goods Regulations (DGR). These are currently the
standard.
strictest regulations:
1.6 This standard does not purport to address all of the
Packing Instructions 602 Packing Instructions—Class
safety concerns, if any, associated with its use. It is the
6—Toxic and Infectious Substances—Infectious Sub-
responsibility of the user of this standard to establish appro-
stance
priate safety and health practices and determine the applica-
Packing Instructions 650 Packing Instructions—Class
bility of regulatory limitations prior to use. Some specific
6—Toxic and Infectious Substances—Diagnostic Speci-
hazards statements are given in Section 7 on Hazards.
men
2.4 ISO Standards:
2. Referenced Documents
ISO 11607–1 Packaging for Terminally Sterilized Medical
2.1 ASTM Standards: Devices—Part 1: Requirements for Materials, Sterile Bar-
D4840 Guide for Sample Chain-of-Custody Procedures
rier Systems and Packaging Systems
ISO 11607–2 Packaging for Terminally Sterilized Medical
2.2 Federal Standards and Regulatory Bodies:
Devices—Part 2: Validation Requirements for Forming,
DOT49CFR172.323 Transportation—HazardousMaterials
Sealing and Assembly Processes
Table, Special Provisions, Hazardous Materials
Communications, Emergency Response Information, 2.5 UN Dangerous Transport Standards:
UN 1845 Carbon dioxide, solid, also called dry ice
UN 2814 Infectious substance, affecting humans (Risk
1 Group 2)
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
UN 2900 Infectious substance, affecting animals
F04.15 on Material Test Methods.
UN 3373 Biological substance, Category B
Current edition approved March 1, 2013. Published August 2013. DOI: 10.1520/
F2995-13.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Available from International Air Transport Association (IATA), http://
Standards volume information, refer to the standard’s Document Summary page on www.iata.org.
the ASTM website. Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments, 4th Floor, New York, NY 10036, http://www.ansi.org.
732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:// Available from United Nations Economic Commission for Europe (UNECE),
www.access.gpo.gov. 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 States
F2995 − 13
2.6 United States Postal Service (USPS). 4.2 General Classification Codes (outlined in DOT 49 CFR
173.2):
3. Terminology
4.2.1 Class 1: Explosives:
3.1 Regulatory Definitions (from DOT 49 CFR 173.134):
4.2.1.1 Division 1.1—Mass explosive hazard.
3.1.1 biological product—a virus, therapeutic serum, toxin,
4.2.1.2 Division 1.2—Projection hazard.
antitoxin, vaccine, blood, blood component or derivative,
4.2.1.3 Division 1.3—Mass fire hazard.
tissue, allergenic product, or analogous product used for
4.2.1.4 Division 1.4—Minor explosion hazard.
diagnosis, treatment, or cure of diseases in human or animals.
4.2.1.5 Division 1.5—Very insensitive explosives.
3.1.2 cultures and stocks—materials prepared and main-
4.2.1.6 Division 1.6—Extremely insensitive explosives.
tained for the growth and storage of pathogens, and contain a
4.2.2 Class 2: Gases:
Risk Group 2, 3, or 4 infectious substance (see 4.3.2).
4.2.2.1 Division 2.1—Flammable gases.
3.1.3 diagnostic specimen—any human or animal material,
4.2.2.2 Division 2.2—Non-flammable gases.
including excreta, secreta, blood and its components, tissues,
4.2.2.3 Division 2.3—Poisonous or toxic.
and tissue fluids, being transported for diagnostic or investiga-
4.2.2.4 Includes compressed, dissolved under pressure, or
tional purposes, excluding live infected humans or animals.
pressurized cryogenic liquids, and liquefied gases.
3.1.4 infectious substance—a material known or suspected
4.2.3 Class 3: Flammable liquid—material whose flash
to contain a pathogen.
point is not more than 141ºF.
3.1.4.1 Discussion—In older regulations and at the USPS,
4.2.4 Class 4: Flammable solids:
infectious substances are often referred to as etiologic agents.
4.2.4.1 Division 4.1—Flammable solid.
3.1.5 pathogen—a virus or micro-organism (including its
4.2.4.2 Division 4.2—Spontaneously combustible material.
viruses, plasmids, or genetic elements) with the potential to
4.2.4.3 Division 4.3—Dangerous when wet.
cause disease to humans or animals.
4.2.5 Class 5: Oxidizing Substances; Organic Peroxides:
3.1.6 regulated medical waste—a waste or reusable material
4.2.5.1 Division 5.1—Oxidizer.
known or suspected to contain an infectious substance in Risk
4.2.5.2 Division 5.2—Organic peroxide.
Group 2 or 3, generated in the diagnosis, treatment, or
4.2.6 Class 6: Poisonous (Toxic) and Infectious Substances:
immunizationofhumansoranimals,orproductionortestingof
4.2.6.1 Division 6.1—Poisonous (toxic) material.
biological products.
4.2.6.2 Division 6.2—Infectious substance.
3.1.7 risk group—assigned by World Health Organization
4.2.7 Class 7: Radioactive Material.
(WHO) based on severity of the disease caused by the
4.2.8 Class 8: Corrosives.
organisms, the mode and relative ease of transmission, the
4.2.9 Class 9: Miscellaneous Dangerous Goods.
degreeofrisktobothanindividualandthecommunity,andthe
4.2.9.1 Includes environmentally hazardous substances, el-
reversibility of the disease through availability of known and
evated temperature materials, hazardous wastes, and marine
effective preventative agents and treatments.
pollutants.
3.1.8 sharps—any object contaminated with a pathogen or
4.3 Infectious Substance Classifications:
maybecontaminatedandalsocapableofcuttingorpenetrating
4.3.1 According to IATA Packing Instructions 650, the
skin or packaging material; this includes needles, syringes,
categories for classification of biological materials are infec-
scalpels, broken glass, culture slides, culture dishes, broken
tious substances, in either CategoryAor Category B, diagnos-
capillarytubes,brokenrigidplastic,andexposedendsofdental
tic specimens, and biological products. Component classifica-
and suture wire.
tioncanbeassignedthroughtheuseoftheflowchartin7.1.As
3.1.9 used health care product—a medical, diagnostic or
of January 1, 2007, diagnostic specimen and biological speci-
research device, piece of equipment or implant, or a personal
men are no longer acceptable shipping names.
care product used by consumers, medical professionals, or
4.3.1.1 Infectious substances in Category A are capable of
pharmaceutical providers that does not meet the requirements
causing permanent disability, life threatening or fatal disease to
of a diagnostic specimen, biological product, or regulated
humans or animals when exposure occurs. They are classified
medical waste; this product is contaminated with potentially
for shipping by their effect to humans or animals. In accor-
infectious bodily fluids or materials and has not been decon-
dance with IATA Packing Instructions 650, these substances
taminated to remove or mitigate the infectious hazard prior to
mustbeintriplepackaging.Themaximumquantitythatcanbe
transportation.
shipped by air is 4 L or 4 kg in one package. On a passenger
carrier,theamountisdecreasedto50mLor50g.Nosubstance
3.2 Definitions of Terms Specific to This Standard:
3.2.1 implant—any permanent or temporary device im- may be carried into the cabin of the plane. The package must
planted into a human. display a label on two opposite sides. This label must include:
(1) The sender’s name and address,
3.2.2 materials—any portion of an artificial implant.
(2) The recipient’s name and address,
4. Classification of Dangerous Substances
(3) An infectious substance label,
4.1 There are a number of different regulatory agencies, (4) The proper shipping name,
each of whom has their own classifications. A summary is (5) The UN number, and
included in 4.2. (6) The net quantity of infectious substance.
F2995 − 13
The proper shipping names and UN identification numbers treatment and preventative measures are available. In this case,
are “Infectious Substances,Affecting Humans” (UN 2814) and there is a high risk to the individual but not to the community.
“Infectious Substances, Affecting Animals” (UN 2900), ac-
4.3.5 Risk Group 2 pathogens can cause human or animal
cordingly. The name and telephone number of person respon-
disease but are unlikely to be a serious hazard, and, while
sible for shipment must also appear on the label of the outer
capable of causing serious infection on exposure, for which
packaging, as well as a “Cargo Aircraft Only” label if the
there are effective treatments and preventative measures avail-
quantity for shipping is larger 50 mLor 50 g.Also, if packaged
able and the risk of spreading the infection is limited. The risk
with dry ice, a Class 9 label, including UN 1845, must be
to the individual in this case is moderate and the risk to the
attached including the net weight of the dry ice.
community is low.
4.3.1.2 Category B includes substances that are infectious
4.3.5.1 Risk Group 1 includes microorganisms that are
but do not meet requirements for CategoryA. For shipping, the
unlikely to cause human or animal disease. Materials contain-
package requires the identification number UN 3373 with the
ing only such microorganisms are not subject to the shipping
following proper shipping names (note that the names should
requirements for infectious materials, since there is no or very
be in all capital letters:
low risk to the individual and the community.
(1) “BIOLOGICALSUBSTANCE, CATEGORYB”;As of
4.3.6 Biological products, in addition to those items speci-
January 1, 2007, shipping names “Diagnostic Specimen” and
fied earlier (3.1.1), include materials manufactured and distrib-
“Clinical Specimen” will no longer be permitted. As with the
uted in accordance with various CFR sections of the DOT.
Category A substances, triple packaging is required, meeting
IATA Packing Instructions 650 specifications. The maximum These sections cover licenses for biological products; experi-
quantity for the primary container is 500 mL or 500 g and the mental products, distribution, and evaluation of biological
outerpackagingmustnotcontainmorethan4Lor4kg.Labels
products prior to licensing; permits for biological products;
mustbedisplayedontwooppositesidesoftheouterpackaging
investigational new drug application; applications for FDA
andmustincludethesender’snameandaddress,therecipient’s
approval to market a new drug; and biologics. If the material
name and address, the proper shipping name and UN number,
contains pathogens in Risk Group 2, 3, or 4, it must be
and a Class 9 label, including UN 1845 and net weight, if
described as an infectious substance and assigned to UN 2814
packaged in dry ice. A Class 9 label is not needed when using
or UN 2900 as appropriate, unless otherwise excepted.
IATAPackaging Instructions 602 and 650. If the substance is a
4.3.7 A diagnostic specimen, as defined previously (3.1.3),
diagnostic specimen or a biological product and the source
is not assigned a UN identification number unless the source
patient has or is suspected of having a serious disease that can
patient or animal has or may have a serious human or animal
be passed from one individual to another, and for which there
disease from a pathogen of Risk Group 4. In this case, the
are no effective preventative measures or treatments, these
material should be classified under Division 6.2 infectious
substances must be shipped as Category A materials with an
substances and assigned to UN 2814 or UN 2900, as appro-
identification number of UN 2814 or UN 2900, as appropriate.
priate.
4.3.1.3 If there is doubt if a substance meets the require-
4.3.8 Regulated medical waste containing an infectious
ments of Category B, then it shall be listed as Category A.
material of Risk Group 4 must be classified in Division 6.2 as
4.3.2 Classification according to the DOT requires that the
an infectious substance, and assigned the appropriate UN
pathogenbeassignedtoaRiskGroup(seeNote1)basedonthe
identification number.
known medical history and condition of the source patient or
4.3.9 The following exceptions are not subject to the re-
animal, the endemic local conditions, the symptoms of the
source patient or animal, or by professional judgment. The quirements of Division 6.2:
Risk Group is assigned by the World Health Organization
4.3.10 A biological or diagnostic product containing patho-
(WHO) based on the severity of the disease caused by the
gens from Risk Group 1 or
...
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