ASTM F2995-24
(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, including packaging and shipping.
1.2 This guide does not address any materials, tissues, or fluids that may contain prions.
1.3 Individuals must 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F2995 − 24
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.
3
1. Scope 2.2 Federal Standards and Regulatory Bodies:
DOT 49 CFR 172.700 Purpose and Scope
1.1 This guide provides a general guide to transportation,
DOT 49 CFR 172.101–172.800 Transportation—Hazardous
including packaging and shipping, of possibly infectious
Materials Table, Special Provisions, Hazardous Materials
materials, tissues, and fluids that have been removed from
Communications, Emergency Response Information,
patients during revision surgery, at postmortem, or as part of
Training Requirements, and Security Plans—Infectious
animal studies, including packaging and shipping.
Substances
1.2 This guide does not address any materials, tissues, or
DOT 49 CFR 173.134 Transportation—Shippers—General
fluids that may contain prions.
Requirements for Shipments and Packagings—Class 6,
Division 6.2—Definitions and Exceptions
1.3 Individuals must be properly trained prior to shipping
DOT 49 CFR 173.3 Transportation—Shippers—General
possibly infectious materials.
Requirements for Shipments and Packagings—Hazardous
1.4 This guide is a compilation of national and international
Materials Classes and Index to Hazard Class Definitions
regulations and guidelines that apply to the packaging and
DOT 49 CFR 178 Transportation—Other Regulations Relat-
shipment of possibly infectious materials.
ing to Transportation—Specifications for Packagings
DOT 49 CFR 178.602 Preparation of Packagings and Pack-
1.5 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this ages for Testing
DOT 49 CFR 178.609 Transportation—Testing of Non-Bulk
standard.
Packagings and Packages—Preparation of Packagings and
1.6 This standard does not purport to address all of the
Packages for Testing
safety concerns, if any, associated with its use. It is the
29 CFR Part 1910.1030 Occupational Safety and Health
responsibility of the user of this standard to establish appro-
Standards—Bloodborne Pathogens
priate safety, health, and environmental practices and deter-
2.3 International Air Transport Association (IATA) uses
mine the applicability of regulatory limitations prior to use.
Dangerous Goods Regulations (DGR). These are currently the
1.7 This international standard was developed in accor-
4
strictest regulations:
dance with internationally recognized principles on standard-
Packing Instructions 620 Packing Instructions—Division
ization established in the Decision on Principles for the
6.2—Category A Infectious Substances
Development of International Standards, Guides and Recom-
Packing Instructions 650 Packing Instructions—Division
mendations issued by the World Trade Organization Technical
6.2—Category B Infectious Substances
Barriers to Trade (TBT) Committee.
5
2.4 ISO Standards:
2. Referenced Documents ISO 11607-1 Packaging for Terminally Sterilized Medical
2 Devices—Part 1: Requirements for Materials, Sterile Bar-
2.1 ASTM Standards:
rier Systems and Packaging Systems
D4840 Guide for Sample Chain-of-Custody Procedures
ISO 11607-2 Packaging for Terminally Sterilized Medical
Devices—Part 2: Validation Requirements for Forming,
Sealing and Assembly Processes
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
3
Current edition approved Jan. 15, 2024. Published January 2024. Originally Available from U.S. Government Printing Office Superintendent of Documents,
approved in 2013. Last previous edition approved in 2016 as F2995 – 16. DOI: 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
10.1520/F2995-24. www.access.gpo.gov.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from International Air Transport Association (IATA), http://
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM www.iata.org.
5
Standards volume information, refer to the standard’s Document Summary page on Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-29
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2995 − 16 F2995 − 24
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
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,
including packaging and shipping.
1.2 This guide does not address any materials, tissues, or fluids that may contain prions.
1.3 Individuals must 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 healthsafety, health, and environmental practices and determine
the applicability of regulatory limitations prior to use. Some specific hazards statements are given in Section 7 on Hazards.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
D4840 Guide for Sample Chain-of-Custody Procedures
3
2.2 Federal Standards and Regulatory Bodies:
DOT 49 CFR 172.700 Purpose and Scope
DOT 49 CFR 172.101—172.800172.101–172.800 Transportation—Hazardous Materials Table, Special Provisions, Hazardous
Materials Communications, Emergency Response Information, Training Requirements, and Security Plans—Infectious
Substances
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.15
on Material Test Methods.
Current edition approved Nov. 15, 2016Jan. 15, 2024. Published January 2017January 2024. Originally approved in 2013. Last previous edition approved in 20132016
as F2995F2995 – 16. – 13. DOI: 10.1520/F2995-16.DOI: 10.1520/F2995-24.
2
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 Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available 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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F2995 − 24
DOT 49 CFR 173.134 Transportation—Shippers—General Requirements for Shipments and Packagings—Class 6, Division
6.2—Definitions and Exceptions
DOT 49 CFR 173.3 Transportation—Shippers—General Requirements for Shipments and Packagings—Hazardous Materials
Classes and Index to Hazard Class Definitions
DOT 49 CFR 178 Transportation—Other Regulations Relating to Transportation—Specifications for Packagings
DOT 49 CFR 178.602 Preparation of Packagings and Packages for Testing
DOT 49 CFR 178.609 Transportation—Testing of Non-Bulk Packagings and Packages—Preparation of Packagings and
Packages for Testing
29 CFR Part 1910.1030 Occupational Safety and Health Standards—Bloodborne Pathogens
2.3 International Air Transport Association (IATA) uses Dangerous Goods Regulations (DGR). These are currently the strictest
4
regulations:
Packing Instructions 620 Packing Instructions—Division 6.2—Category A Infectious Substances
Packing Instructions 650 Packing Instructions—Division 6.2—Category B Infectious Substances
5
2.4 ISO Standards:
ISO 11607–111607-1 Packaging for Terminally Sterilized Medical Devices—Part 1: Requirements for Materials, Sterile Barrier
Systems and Pa
...
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