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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 038 Date of Entry 01/27/2015 
FR Recognition Number 14-456
Standard
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
Identical Adoption
ANSI AAMI ISO TIR16775:2014
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
Scope/Abstract
ISO/TS 16775:2014 provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2. It does not add to, or otherwise change, the requirements of ISO 11607-1 and/or ISO 11607-2. It is an informative document, not normative, and does not include requirements to be used as basis of regulatory inspection or certification assessment activities.
The guidance can be used to better understand the requirements of ISO 11607-1 and/or ISO 11607-2 and illustrates some of the variety of methods and approaches available for meeting the requirements of those International Standards. It is not required to be used to demonstrate compliance with them.
Guidelines are given for evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. Guidance on validation requirements for forming, sealing and assembly processes is also given.
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FDA recognition of ISO /TS 16775 First edition 2014-05 [Rec# 14-456] will be superseded by recognition of ISO /TS 16775 Second edition 2021-11 [Rec# 14-585]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-456] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 14-456] 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 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.


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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