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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 055 Date of Entry 12/21/2020 
FR Recognition Number 18-17
Standard
ISO  21363 First edition 2020-06
Nanotechnologies - Measurements of particle size and shape distributions by transmission electron microscopy
Scope/Abstract
This document specifies how to capture, measure and analyse transmission electron microscopy images to obtain particle and shape distributions in the nanoscale.
This document broadly is applicable to nano-objects as well as to particles with s larger than 100 nm. The exact working range of the method depends on the required uncertainty and on the performance of the transmission electron microscope. These elements can be evaluated according to the requirements described in this document.
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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