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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 038 Date of Recognition 01/27/2015 
FR Recognition Number 14-242
Standard
ISO 14644-3 First edition 2005-12-15
Cleanrooms and associated controlled environments - Part 3: Test methods
Scope/Abstract
ISO 14644-3:2005 specifies test methods for designated classification of airborne particulate cleanliness and for characterizing the performance of cleanrooms and clean zones. Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional flow and those with non-unidirectional flow, in three possible occupancy states: as-built, at-rest and operational.

ISO 14644-3:2005 is not applicable to the measurement of products or of processes in cleanrooms or separative devices.

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
AAMI TIR52:2014/(R)2017, Environmental Monitoring for Terminally Sterilized Healthcare Products.
FDA Technical Contact
 Christopher Brown
  FDA/OMPT/CDRH/OC/DMQ/R/ENT/GH-ODB/
  301-796-0380
  Christopher.Brown@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Sterility
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