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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 5-126
Standard
ISTA  3A 2018
Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
Scope/Abstract
Test Procedure 3A covers testing of individual packaged-products 70 kilograms (150 pounds) or less when prepared for shipment via a parcel delivery carrier.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
21 CFR Part 820 Quality System Regulation
Subpart O - Statistical Techniques, Section 820.250 Statistical techniques
Subpart C - Design Controls, Section 820.30(g) Design validation
Relevant FDA Guidance and/or Supportive Publications*
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.

ISO/TS 16775 First edition 2014-05-15 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2.


Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Patrick Weixel
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/
  301-796-5537
  Patrick.Weixel@fda.hhs.gov
Standards Development Organization
ISTA International Safe Transit Association (ISTA) https://www.ista.org/
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.
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