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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 054 Date of Entry 07/06/2020 
FR Recognition Number 14-543
Standard
ISO  11139 First edition 2018-08
Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards
Scope/Abstract
This document defines terms in the field of the sterilization of health care products including related equipment and processes.
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*
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 Contact
 Victoria Rodriguez
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIB/
  240-402-3799
  Victoria.Rodriguez@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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