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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Recognition 04/04/2016 
FR Recognition Number 14-407
Standard
ISO 11737-1 Second edition 2006-04-01
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products [Including: Technical Corrigendum 1 (2007)]
U.S. Identical Adoption
ANSI AAMI ISO 11737-1:2006 (R)2011
Sterilization of health care products - Microbiological methods - Part 1: Determination of the population of microorganisms on product
Scope/Abstract
ISO 11737-1:2006 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable micro-organisms on or in a medical device, component, raw material or package.
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FDA recognition of ISO 11737-1 Second edition 2006-04-01[Rec# 14-407] will be superseded by recognition of ISO 11737-1 Third edition 2018-01 [Rec# 14-514]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-407] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 14-407] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications
ISO 11737-2 Second edition 2009-11-15 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
FDA Technical Contact
 Elizabeth Gonzalez
  FDA/OMPT/CDRH/ODE/DRGUD/RNDB/
  301-796-6826
  Elizabeth.Gonzalez@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Sterility
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