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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 14-243
Standard
ISO  14644-6 First edition 2007-07-15
Cleanrooms and associated controlled environments - Part 6: Vocabulary
Scope/Abstract
ISO 14644-6:2007 establishes a vocabulary of terms and definitions related to cleanrooms and associated controlled environments.
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, 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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