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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 030 Date of Recognition 01/15/2013 
FR Recognition Number 14-377
ASTM F2638-12
Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
1.1 This test method measures the aerosol filtration performance of porous packaging materials by creating a defined aerosol of 1.0 μm particles and assessing the filtration efficiency of the material using either single or dual particle counters.

1.2 This test method is applicable to porous materials used to package terminally sterilized medical devices.

1.3 The intent of this test method is to determine the flow rate through a material at which maximum penetration occurs. The porous nature of some materials used in sterile packaging applications might preclude evaluation by means of this test method. The maximum penetration point of a particular material could occur at a flow rate that exceeds the flow capacity of the test apparatus. As such, this test method may not be useful for evaluating the maximum penetration point of materials with a Bendtsen flow rate above 4000 mL/min as measured by ISO 5636-3.

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FDA recognition of ASTM F2638-12 [Rec# 14-377] will be superseded by recognition of ASTM F2638-18 [Rec# 14-527]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-377] until July 26, 2020. After this transition period, declarations of conformity to [Rec# 14-377] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications
ANSI/AAMI/ISO 11607-1:2006(R2010) Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including: Amendment 1 (2014)].

ANSI/AAMI/ISO 11607-2:2006(R2010) Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly process [Including: Amendment 1 (2014)].

ANSI/AAMI/ISO TIR16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2.
FDA Technical Contact
 Patrick Weixel
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)