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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 14-379
Standard
ISO  14644-8 Second edition 2013-02-15
Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
Scope/Abstract
ISO 14644-8:2013 establishes the classification of air chemical cleanliness (ACC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group or category) and provides a protocol to include test methods, analysis and time-weighted factors within the specification for classification.
ISO 14644-8:2013 currently considers only concentrations of air chemical contaminants between 100 and 10−12 g/m3 under cleanroom operational conditions.
ISO 14644-8:2013 is not relevant for application in those industries, processes or productions where the presence of airborne chemical substances is not considered a risk to the product or process.
It is not the intention of ISO 14644-8:2013 to describe the nature of air chemical contaminants.
ISO 14644-8:2013 does not give a classification of surface chemical contamination.
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FDA recognition of ISO 14644-8 Second edition 2013-02 [Rec# 14-379] will be superseded by recognition of ISO 14644-8 Third edition 2022-06 [Rec# 14-590]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-379] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 14-379] will not be accepted.
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 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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