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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 038 Date of Entry 01/27/2015 
FR Recognition Number 14-389
Standard
ISO  14644-9 First edition 2012-08-15
Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration
Scope/Abstract
ISO 14644-9:2012 establishes the classification of cleanliness levels on solid surfaces by particle concentration in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics are also given
ISO 14644-9:2012 applies to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, working environments, tools, equipment and products. The surface particle cleanliness (SPC) classification is limited to particles between 0,05 µm and 500 µm.
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FDA recognition of ISO 14644-9 First edition 2012-08-15 [Rec# 14-389] will be superseded by recognition of ISO 14644-9 Second edition 2022-05 [Rec# 14-599]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-389] until July 04, 2027. After this transition period, declarations of conformity to [Rec# 14-389] will not be accepted.
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
 Sandra Boyd
  RA/OMPTO/OPQO/DPQP/PQPB/
  414-326-3987
  Sandra.Boyd@fda.hhs.gov
 Christopher Brown
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  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
*These are provided as examples and others may be applicable.
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