ASTM F2995 - 16

    Standard Guide for Shipping Possibly Infectious Materials, Tissues, and Fluids

    Active Standard ASTM F2995 | Developed by Subcommittee: F04.15

    Book of Standards Volume: 13.02

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    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 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.

    ASTM Standards

    D4840 Guide for Sample Chain-of-Custody Procedures

    Federal Standards and Regulatory Bodies

    29 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 cu

    Packing 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 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 Requirements for Forming, Sealing and Assembly Processes

    UN Dangerous Transport Standards

    UN 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 Code

    ICS Number Code 13.300 (Protection against dangerous goods)

    UNSPSC Code

    UNSPSC Code

    Referencing This Standard
    Link Here
    Link to Active (This link will always route to the current Active version of the standard.)

    DOI: 10.1520/F2995-16

    Citation Format

    ASTM F2995-16, Standard Guide for Shipping Possibly Infectious Materials, Tissues, and Fluids, ASTM International, West Conshohocken, PA, 2016,

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