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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 052 Date of Entry 07/15/2019 
FR Recognition Number 18-13
Standard
ISO  TS 18827 First edition 2017-06
Nanotechnologies - Electron spin resonance (ESR) as a method for measuring reactive oxygen species (ROS) generated by metal oxide nanomaterials
Scope/Abstract
This document provides a procedure for the detection of ROS (OH, O2-, 1O2) generated by metal oxide nanomaterials in aqueous solution with a reactive oxygen species-specific spin trapping agent using ESR, but excludes ESR procedures that do not use a spin trapping agent.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Section 3.1.1 - Nanomaterial
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 3.1.1 - Nanomaterial is in conflict with a final published guidance. See Section "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

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
 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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