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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 043 Date of Entry 06/27/2016 
FR Recognition Number 14-481
Standard
ISO  14644-2 Second edition 2015-12-15
Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
Scope/Abstract
ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644 7.
Only particle populations having cumulative distributions based on threshold (lower limit) particle s ranging from 0,1 µm to 5 µm are considered for classification purposes.
The use of light scattering (discrete) airborne particle counters (LSAPC) is the basis for determination of the concentration of airborne particles, equal to and greater than the specified s, at designated sampling locations.
ISO 14644-1:2015 does not provide for classification of particle populations that are outside the specified lower threshold particle- range, 0,1 µm to 5 µm. Concentrations of ultrafine particles (particles smaller than 0,1 µm) will be addressed in a separate standard to specify air cleanliness by nano-scale particles. An M descriptor (see Annex C) may be used to quantify populations of macroparticles (particles larger than 5 µm).
ISO 14644-1:2015 cannot be used to characterize the physical, chemical, radiological, viable or other nature of airborne particles.
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.

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 Contacts
 Christopher Brown
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-0380
  Christopher.Brown@fda.hhs.gov
 Sandra Boyd
  RA/OMPTO/OPQO/DPQP/PQPB/
  414-326-3987
  Sandra.Boyd@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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