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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 038 Date of Entry 01/27/2015 
FR Recognition Number 18-3
Standard
ISO TS 14101 First edition 2012-11-01
Surface characterization of gold nanoparticles for nanomaterial specific toxicity screening: FT-IR method
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
3.7 nano-object
3.8 nanoparticles
3.9 nanoscales
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.

This standard is recognized in part because:
Section 3.7, 3.8 and 3.9 are in conflict with published final guidance. See "II Discussion A. Points to Consider" in the guidance listed below.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology", Issued June 2014
FDA Technical Contact
 Jiwen Zheng
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-3352
  jiwen.zheng@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Nanotechnology
*These are provided as examples and others may be applicable.
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