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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 14-591
Standard
ISO  14644-10 Second edition 2022-05
Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination
Scope/Abstract
This document establishes appropriate testing processes to determine the cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). This document is applicable to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, worksurfaces, tools, equipment and devices.

NOTE 1 For the purpose of this document, consideration is only given to the chemical characteristics of a particle. The physical properties of the particle are not considered and this document does not cover the interaction between the contamination and the surface.

NOTE 2 This document does not include the contamination generation process or any time-dependent influences (e.g. deposition, sedimentation, ageing) or process-dependent activities such as transportation and handling. Neither does it include guidance on statistical quality-control techniques to ensure compliance.
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FDA recognition of ISO 14644-10 First edition 2013-03 [Rec# 14-390] will be superseded by recognition of ISO 14644-10 Second edition 2022-05 [Rec# 14-591]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-390] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 14-390] 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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