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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 052 Date of Entry 07/15/2019 
FR Recognition Number 14-531
Standard
ISO  11607-2 Second edition 2019-02
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
Identical Adoption
ANSI AAMI ISO 11607-2:2019
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
Scope/Abstract
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
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.
Transition Period
FDA recognition of ISO 11607-2 Second edition 2019-02 [Rec# 14-531] will be superseded by recognition of ISO 11607-2 Second edition 2019-02 [Including AMD1:2023] [Rec# 14-595]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-531] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 14-531] will not be accepted.
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/TS 16775 Second edition 2021-11 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
 Steven Turtil
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIB/
  301-796-6305
  steven.turtil@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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