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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 052 Date of Entry 07/15/2019 
FR Recognition Number 14-529
Standard
ISO  11135 Second edition 2014-07-15
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
Identical Adoption
ANSI AAMI ISO 11135:2014/A1:2018
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release
Scope/Abstract
ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
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*
1. AAMI TIR14:2016 Contract sterilization using ethylene oxide.

2. AAMI TIR15:2016 Physical aspects of ethylene oxide sterilization.

3. AAMI TIR16:2017 Microbiological aspects of ethylene oxide sterilization.

4. AAMI TIR17:2017 Compatibility of materials subject to sterilization.

5. AAMI TIR28:2016 Product adoption and process equivalence for ethylene oxide sterilization.

6. AAMI TIR74:2016 (R2021) Change summary for ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.

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
 Hiren Mistry
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  301-796-8225
  Hiren.Mistry@fda.hhs.gov
 Steven Turtil
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIB/
  301-796-6305
  steven.turtil@fda.hhs.gov
 Salvatore Randazzo
  FDA/OC/ORA/OMPTO/OMDRHO/DMDRHOII/MDRHCB/
  407-475-4700
  salvatore.randazzo@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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