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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.
1.6 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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D4840 Guide for Sample Chain-of-Custody Procedures
Federal Standards and Regulatory Bodies29CFRPart1910.1030 Occupational Safety and Health Standards--Bloodborne Pathogens DOT49CFR172.323 Transportation--Hazardous Materials Table, Special Provisions, Hazardous Materials Communications, Emergency Response Information, Training Requirements, and Security Plans--Infectious Substances DOT49CFR173.134 Transportation--Shippers--General Requirements for Shipments and Packagings--Class 6, Division 6.2--Definitions and Exceptions DOT49CFR173.2 Transportation--Shippers--General Requirements for Shipments and Packagings--Hazardous Materials Classes and Index to Hazard Class Definitions DOT49CFR178.602 Transportation--Testing of Non-Bulk Packagings and Packages--Preparation of Packagings and Packages for Testing DOT49CFR178 Transportation--Other Regulations Relating to Transportation--Specifications for Packagings
International Air Transport Association (IATA) uses Dangerous Goods Regulations (DGR). These are cuPackingInstructions6 Packing Instructions--Class 6--Toxic and Infectious Substances--Diagnostic Specimen PackingInstructions6 Packing Instructions--Class 6--Toxic and Infectious Substances--Infectious Substance
ISO StandardsISO11607–1 Packaging for Terminally Sterilized Medical Devices--Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems ISO11607–2 Packaging for Terminally Sterilized Medical Devices--Part 2: Validation Requirements for Forming, Sealing and Assembly Processes
UN Dangerous Transport StandardsUN1845 Carbon dioxide, solid, also called dry ice UN2814 Infectious substance, affecting humans (Risk Group 2) UN2900 Infectious substance, affecting animals UN3373 Biological substance, Category B
ICS Number Code 13.300 (Protection against dangerous goods)
ASTM F2995-13, Standard Guide for Shipping Possibly Infectious Materials, Tissues, and Fluids, ASTM International, West Conshohocken, PA, 2013, www.astm.orgBack to Top