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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 058 Date of Entry 05/30/2022 
FR Recognition Number 14-573
Standard
ASTM  F88/F88M-21
Standard Test Method for Seal Strength of Flexible Barrier Materials
Scope/Abstract
1.1 This test method covers the measurement of the strength of seals in flexible barrier materials.
1.2 The test may be conducted on seals between a flexible material and a rigid material.
1.3 Seals tested in accordance with this test method may be from any source, laboratory or commercial.
1.4 This test method measures the force required to separate a test strip of material containing the seal. It also identifies the mode of specimen failure.
1.5 This test method differs from Test Method F2824. Test Method F2824 measures mechanical seal strength while separating an entire lid (cover/membrane) from a rigid or semi-rigid round container.
1.6 This test method differs from Test Method F904. Test Method F904 measures the bond strength or ply adhesion of laminates made from flexible materials such as cellulose, paper, plastic film, and foil.
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FDA recognition of ASTM F88/F88M-21 [Rec# 14-573] will be superseded by recognition of ASTM F88/F88M-23 [Rec# 14-596]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-573] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 14-573] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
This standard is relevant for all medical devices where sterilization is a component of the development and manufacture of the product
Relevant FDA Guidance and/or Supportive Publications*
1. ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.

2. ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.

3. 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
 Patrick Weixel
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/
  301-796-5537
  Patrick.Weixel@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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