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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 066 Date of Entry 05/25/2026 
FR Recognition Number 18-25
Standard
ISO  21362 First edition 2026-02
Nanotechnologies -- Analysis of nano-objects using asymmetrical flow and centrifugal field-flow fractionation
Scope/Abstract
This document describes the general principles of field-flow fractionation and specifies parameters, conditions and minimal reporting requirements, as part of an integrated measurement system, required to develop and validate methods for the application of asymmetrical flow and centrifugal field-flow fractionation in the analysis of nano-objects and their aggregates and agglomerates in aqueous media. General guidelines and procedures are provided to aid the user.
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.
Transition Period
FDA recognition of ISO TS 21362 First edition 2018-06 [Rec# 18-16] will be superseded by recognition of ISO 21362 First edition 2026-02 [Rec# 18-25]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 18-16] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 18-16] will not be accepted.
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/OPEQ/OHTII/DHTIIC/
  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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