Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

038

Date of Entry 01/27/2015

FR Recognition Number

14-389

Standard

ISO 14644-9 First edition 2012-08-15
Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration

Scope/Abstract

ISO 14644-9:2012 establishes the classification of cleanliness levels on solid surfaces by particle concentration in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics are also given
ISO 14644-9:2012 applies to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, working environments, tools, equipment and products. The surface particle cleanliness (SPC) classification is limited to particles between 0,05 µm and 500 µm.

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/(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

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