• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 062 Date of Entry 05/29/2024 
FR Recognition Number 14-599
Standard
ISO  14644-9 Second edition 2022-05
Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration
Scope/Abstract
This document establishes a procedure for the assessment of particle cleanliness levels on solid surfaces in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics, are given in Annexes A to D.

This document applies to all solid surfaces in cleanrooms and associated controlled environments, such as walls, ceilings, floors, working environments, tools, equipment and products. The procedure for the assessment of surface cleanliness by particle concentration (SCP) is limited to particles of between 0,05 µm and 500 µm.

The following issues are not considered in this document:

- requirements for the cleanliness and suitability of surfaces for specific processes;

- procedures for the cleaning of surfaces;

- material characteristics;

- references to interactive bonding forces or generation processes that are usually time-dependent and process-dependent;

- selection and use of statistical methods for assessment and testing;

- other characteristics of particles, such as electrostatic charge, ionic charges and microbiological state.
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FDA recognition of ISO 14644-9 First edition 2012-08-15 [Rec# 14-389] will be superseded by recognition of ISO 14644-9 Second edition 2022-05 [Rec# 14-599].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
 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.
-
-