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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 18-14
Standard
ISO  TR 11360 First edition 2010-07-15
Nanotechnologies - Methodology for the classification and categorization of nanomaterials
Scope/Abstract
This Technical Report describes a classifying system, termed a "nano-tree", upon whose basis wide ranges of nanomaterials can be categorized, including nano-objects, nanostructures and nanocomposites of various dimensionality of different physical, chemical, magnetic and biological properties.

However, the classifying system presented in this Technical Report does not claim to provide full coverage of the whole range of nanomaterials.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Paragraph 2 in Section 2 Nano-tree structure
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:
Paragraph 2 in Section 2 Nano-tree structure is in conflict with published final 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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