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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 14-549
Standard
ASTM  F3004-13 (Reapproved 2020)
Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound
Scope/Abstract
1.1 This standard method describes the technology and testing procedures that can be used to detect seal defects in the range of 1 mm and characterize seal quality in a variety of packaging styles using airborne ultrasound technology.
1.2 This test method does not purport to be the only method for measurement of seal quality.
1.3 Heat seals and other package components can be tested in flexible, semi-rigid and rigid packages. Only the precision and bias for flexible package seals were evaluated in a recent ILS included in the method. The precision and bias for any specific package needs to be individually determined.
1.4 On-line, real time inspection of seals can be considered particularly in the L-Scan mode.
1.5 This method provides a non-destructive, quantitative, non-subjective approach to flexible package seal inspection.
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.
Relevant FDA Guidance and/or Supportive Publications*
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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