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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 061 Date of Entry 12/18/2023 
FR Recognition Number 14-590
Standard
ISO  14644-8 Third edition 2022-06
Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC)
Scope/Abstract
This document establishes typical assessment processes to determine grading levels 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 for their determination. This document currently considers only concentrations of air chemical contaminants between 100 g/m3 and 10-12 g/m3 under cleanroom operational conditions.

This document 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 this document to describe the nature of air chemical contaminants.

This document 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FDA recognition of ISO 14644-8 Second edition 2013-02 [Rec# 14-379] will be superseded by recognition of ISO 14644-8 Third edition 2022-06 [Rec# 14-590].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.
Public Law, CFR Citation(s) and Procode(s)*
21 CFR 820 Quality System Regulation
Relevant FDA Guidance and/or Supportive Publications*
1. Quality System Information for Certain Premarket Application Reviews: Guidance for Industry and FDA Staff, issued February 2003.

2. Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice: Guidance for Industry, issued October 2004.

3. Manufacturing Site Change Supplements: Content and Submission: Guidance for Industry and Food and Drug Administration Staff, issued December 2018.

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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