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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 057 Date of Entry 12/20/2021 
FR Recognition Number 18-19
Standard
ISO  19749 First edition 2021-07
Nanotechnologies - Measurements of particle size and shape distributions by scanning electron microscopy
Scope/Abstract
This document specifies methods of determining nanoparticle and shape distributions by acquiring and evaluating scanning electron microscope images and by obtaining and reporting accurate results.

NOTE 1 This document applies to particles with a lower limit that depends on the required uncertainty and on the suitable performance of the SEM, which is to be proven first -according to the requirements described in this document.

NOTE 2 This document applies also to SEM-based and shape measurements of larger than nanoscale particles.
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 Contacts
 Jiwen Zheng
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-3352
  jiwen.zheng@fda.hhs.gov
 Peter L. Goering
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-0253
  Peter.Goering@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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