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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Historical
Publication Date
28-Feb-2013
Current Stage
Ref Project

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ASTM F2995-13 - Standard Guide for Shipping Possibly Infectious Materials, Tissues, and Fluids
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2995 − 13
Standard Guide for
1
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.
4
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
5
2.4 ISO Standards:
2. Referenced Documents
ISO 11607–1 Packaging for Terminally Sterilized Medical
2
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
3
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
6
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.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4
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.
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the ASTM website. Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
3
AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments, 4th Floor, New York, NY 10036, http://www.ansi.org.
6
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
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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
...

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