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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 051 Date of Entry 01/14/2019 
FR Recognition Number 18-11
Standard
ISO  TR 13121 First edition 2011-05-15
Nanotechnologies - Nanomaterial risk evaluation
Scope/Abstract
This Technical Report describes a process for identifying, evaluating, addressing, making decisions about, and communicating the potential risks of developing and using manufactured nanomaterials, in order to protect the health and safety of the public, consumers, workers and the environment.

While the overall product stewardship and risk management process set forth in this Technical Report is not unique to nanomaterials, it supplements recognized approaches by providing, where possible, a focus on information and issues specific to nanotechnologies. It offers guidance on the information needed to make sound risk evaluations and risk management decisions, as well as how to manage in the face of incomplete or uncertain information by using reasonable assumptions and appropriate risk management practices. Further, it includes methods to update assumptions, decisions, and practices as new information becomes available, and on how to communicate information and decisions to stakeholders.

This Technical Report suggests methods organizations can use to be transparent and accountable in how they manage nanomaterials. To that end, it describes a process of organizing, documenting, and communicating what information organizations have about nanomaterials. This includes acknowledging where information is incomplete, explaining how information gaps were addressed, and explaining the rationale behind the organization's risk management decisions and actions.
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
  FDA/OC/CDRH/OSEL/DBCMS/
  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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