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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 059 Date of Entry 12/19/2022 
FR Recognition Number 18-22
Standard
ISO  17200 First edition 2020-09
Nanotechnology - Nanoparticles in powder form - Characteristics and measurements
Scope/Abstract
This document specifies the fundamental characteristics to be measured of a sample of engineered nanoparticles in powder form to determine the , the chemical content and the surface area. This document also specifies measurement methods for determining each of the characteristics.

It is intended to facilitate communication among consumers, regulators and industries with the necessary characteristics.

It excludes characteristics that pertain to specific industrial applications of nanoparticles in powder form and detailed measurement protocols, as well as characteristics related to health, safety and environmental issues.
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

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
 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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