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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 18-12
Standard
ISO /TS 17200 First edition 2013-06-01
Nanotechnology - Nanoparticles in powder form - Characteristics and measurements
Scope/Abstract
This Technical Specification lists fundamental characteristics which are commonly determined for
nanoparticles in powder form. The Technical Specification prescribes specific measurement methods for each of these characteristics.

This Technical Specification does not specify acceptable quantitative criteria for the characteristics because they are subject to agreement between sellers, buyers, and regulators.
Excluded in this Technical Specification are characteristics specifically related to health, safety, and environmental issues, as well as characteristics that pertain to specific applications of nanoparticles in powder form.
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*
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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