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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 049 Date of Entry 06/07/2018 
FR Recognition Number 18-9
ISO  /TR 13014 First edition 2012-05-15
Nanotechnologies - Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment [Including CORRIGENDUM 1 (2012)].
This Technical Report provides guidance for the physico-chemical characterization of manufactured nano-objects and their aggregates and agglomerates (NOAA) greater than 100 nm presented for toxicological testing in order to aid in assessing and interpreting the toxicological impact of manufactured nano-objects and to allow the material under test to be differentiated from seemingly similar materials. For each of the selected properties, a description, clarification, relevance, measurand and example measurement methods are provided.

This Technical Report will be of value to parties (e.g. toxicologists, ecotoxicologists, regulators, health and safety professionals) interested in assessing and interpreting the potential toxicological effect of manufactured NOAAs.
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
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.