ASTM F2995-16
(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 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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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 − 16
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 terials Communications, Emergency Response
Information,TrainingRequirements,andSecurityPlans—
1.1 This guide provides a general guide to transportation,
Infectious Substances
including packaging and shipping, of possibly infectious
DOT 49 CFR 173.134 Transportation—Shippers—General
materials, tissues, and fluids that have been removed from
Requirements for Shipments and Packagings—Class 6,
patients during revision surgery, at postmortem, or as part of
Division 6.2—Definitions and Exceptions
animal studies, including packaging and shipping.
DOT 49 CFR 173.3 Transportation—Shippers—General
1.2 This guide does not address any materials, tissues, or
Requirements for Shipments and Packagings—Hazardous
fluids that may contain prions.
Materials Classes and Index to Hazard Class Definitions
DOT49 CFR 178 Transportation—Other Regulations Relat-
1.3 Individuals must be properly trained prior to shipping
possibly infectious materials. ing to Transportation—Specifications for Packagings
DOT 49 CFR 178.602 Preparation of Packagings and Pack-
1.4 This guide is a compilation of national and international
ages for Testing
regulations and guidelines that apply to the packaging and
DOT49 CFR 178.609 Transportation—Testing of Non-Bulk
shipment of possibly infectious materials.
PackagingsandPackages—PreparationofPackagingsand
1.5 The values stated in SI units are to be regarded as
Packages for Testing
standard. No other units of measurement are included in this
29 CFR Part 1910.1030 Occupational Safety and Health
standard.
Standards—Bloodborne Pathogens
1.6 This standard does not purport to address all of the
2.3 International Air Transport Association (IATA) uses
safety concerns, if any, associated with its use. It is the
Dangerous Goods Regulations (DGR). These are currently the
4
responsibility of the user of this standard to establish appro-
strictest regulations:
priate safety and health practices and determine the applica-
Packing Instructions 620 Packing Instructions—Division
bility of regulatory limitations prior to use. Some specific
6.2—Category A Infectious Substances
hazards statements are given in Section 7 on Hazards.
Packing Instructions 650 Packing Instructions—Division
6.2—Category B Infectious Substances
2. Referenced Documents
5
2.4 ISO Standards:
2
2.1 ASTM Standards:
ISO 11607–1 Packaging for Terminally Sterilized Medical
D4840 Guide for Sample Chain-of-Custody Procedures
Devices—Part 1: Requirements for Materials, Sterile Bar-
3
2.2 Federal Standards and Regulatory Bodies:
rier Systems and Packaging Systems
DOT 49 CFR 172.700 Purpose and Scope
ISO 11607–2 Packaging for Terminally Sterilized Medical
DOT 49 CFR 172.101—172.800 Transportation—Hazard-
Devices—Part 2: Validation Requirements for Forming,
ous Materials Table, Special Provisions, Hazardous Ma-
Sealing and Assembly Processes
6
2.5 UN Dangerous Transport Standards:
UN 1845 Carbon dioxide, solid, also called dry ice
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
UN 2814 Infectious substance, affecting humans
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
UN 2900 Infectious substance, affecting animals
Current edition approved Nov. 15, 2016. Published January 2017. Originally
UN 3373 Biological substance, Category B
approved in 2013. Last previous edition approved in 2013 as F2995 – 13. DOI:
10.1520/F2995-16.
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.
5
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 In
...
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 − 13 F2995 − 16
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.studies,
including packaging and shipping.
1.2 This guide does not address any materials, tissues, or fluids that may contain prions.
1.3 It is recommended that individuals 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 health practices and determine the applicability of regulatory
limitations prior to use. Some specific hazards statements are given in Section 7 on Hazards.
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 172.323172.101—172.800 Transportation—Hazardous Materials Table, Special Provisions, Hazardous Materials
Communications, Emergency Response Information, Training Requirements, and Security Plans—Infectious Substances
DOT 49 CFR 173.134 Transportation—Shippers—General Requirements for Shipments and Packagings—Class 6, Division
6.2—Definitions and Exceptions
DOT 49 CFR 173.2173.3 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 178.602178.609 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 602620 Packing Instructions—Class 6—Toxic and Infectious Substances—Infectious
SubstanceInstructions—Division 6.2—Category A 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 March 1, 2013Nov. 15, 2016. Published August 2013January 2017. Originally approved in 2013. Last previous edition approved in 2013 as F2995
– 13. DOI: 10.1520/F2995-13.10.1520/F2995-16.
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.
4
Available from International Air Transport Association (IATA), http://www.iata.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F2995 − 16
Packing Instructions 650 Packing Instructions—Class 6—Toxic and Infectious Substances—Diagnostic SpecimenInstructions—
Division 6.2—Category B Infectious Substances
5
2.4 ISO Standards:
ISO 11607–1 Packaging for Terminally Sterilized Medical Devices—Part 1: Requirements for Materials, Sterile Barrier Systems
and Packaging Systems
ISO 11607–2 Packaging for Terminally Sterilized Medical Devices—Part 2: Validation Req
...
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