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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 Bodies29 CFR Part 1910.1030 Occupational Safety and Health Standards--Bloodborne Pathogens DOT 49 CFR 172.323 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 173.2 Transportation--Shippers--General Requirements for Shipments and Packagings--Hazardous Materials Classes and Index to Hazard Class Definitions DOT 49 CFR 178.602 Transportation--Testing of Non-Bulk Packagings and Packages--Preparation of Packagings and Packages for Testing DOT 49 CFR 178 Transportation--Other Regulations Relating to Transportation--Specifications for Packagings
International Air Transport Association (IATA) uses Dangerous Goods Regulations (DGR). These are cuPacking Instructions 602 Packing Instructions--Class 6--Toxic and Infectious Substances--Infectious Substance Packing Instructions 650 Packing Instructions--Class 6--Toxic and Infectious Substances--Diagnostic Specimen
ISO StandardsISO 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 Requirements for Forming, Sealing and Assembly Processes
UN Dangerous Transport StandardsUN 1845 Carbon dioxide, solid, also called dry ice UN 2814 Infectious substance, affecting humans (Risk Group 2) UN 2900 Infectious substance, affecting animals UN 3373 Biological substance, Category B
ICS Number Code 13.300 (Protection against dangerous goods)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM F2995-13, Standard Guide for Shipping Possibly Infectious Materials, Tissues, and Fluids, ASTM International, West Conshohocken, PA, 2013, www.astm.orgBack to Top