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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 047 Date of Entry 08/21/2017 
FR Recognition Number 14-502
Standard
ISO  11138-1 Third edition 2017-03
Sterilization of health care products - Biological indicators - Part 1: General requirements
Identical Adoption
ANSI AAMI ISO 11138-1:2017
Sterilization of health care products - Biological indicators - Part 1: General requirements
Scope/Abstract
ISO 11138-1:2017 specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.

ISO 11138-1:2017 specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies.

NOTE National or regional regulations can apply.

ISO 11138-1:2017 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.
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*
USP 40-NF35:2017 <1229.5> Biological Indicators for Sterilization

USP 40-NF35:2017 <55> Biological Indicators - Resistance Performance Tests

Guidance for Industry and FDA Staff; Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007

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
 Ramesh K. Panguluri
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-6303
  ramesh.panguluri@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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