Medical Application: Standards

Standards Roadmap: Neurotechnologies for Brain-Machine Interfacing, IEEE Standards Association
This document aims at providing an overview of the existing and developing standards in the field of neurotechnologies for brain‐machine interfacing. It is mainly focused on systems that provide a closed‐loop interaction with artificial devices based on information extracted from measures of the activity in the nervous system.

In addition to reviewing the most current standardization efforts, this document also reports on the current opinions on the topic as collected by an online survey conducted with members of the community and presents some recommendations on the perceived priorities for standardization.

International Neuroinformatics Coordinating Facility (INCF)
The mission of the International Neuroinformatics Coordinating Facility (INCF) is to develop, evaluate, and endorse standards and best practices that embrace the principles of Open, FAIR, and Citable neuroscience. INCF also provides training on how standards and best practices facilitate reproducibility and enables the publishing of the entirety of research output, including data and code.

Pertinent Medical Device Standards

  • ISO 14971: Risk Management for medical devices: nonspecific to neurotechnology, but provides an over-arching framework for assessment of potential risks and hazards associated with device use. Traditionally (and presently), the primary focus of this standard is on risks to the safety of the user, but this framework may be extended also to consider pertinent ethical considerations relating to device use (correct or incorrect)
  • ISO 13485: Quality Management Systems or medical device development: Defines the process of design control, starting with the definition of user needs and progressing through the definition of technical requirements and the iterative verification and validation that both technical requirements and user needs are satisfied. (Ref: FDA “waterfall diagram”) under the current standard, the defining of user needs is left to the device developers, and this is where ethical considerations would need to be incorporated in order to be captured by the design control process. However, the fact that many ethical concerns are indirect/circumstantial presents a challenge in terms of the feasibility of testing for such considerations as part of the medical device development process.
  • ISO 14708: Implants for surgery – Active implantable medical devices – Part 3: Implantable neurostimulators
  • ISO 14155: Clinical trials
  • ISO 10993 Biological Evaluation of Medical Devices
  • IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices
  • IEEE P2410- IEEE Draft Standard for Biometric Privacy
  • ISO 9241-11: Ergonomics of Human-System Interaction: Definitions and Concepts
  • ISO 9241-210: Ergonomics of Human System Interaction: Human-centred design processes for interactive systems
  • IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices. International Organization for Standardization.


Standards in Process

  • IEEE Working Group P2731  Unified Terminology for Brain‐Computer Interfaces,
  • IEEE Working Group P2794 Reporting Standard for in vivo Neural Interface Research (RSNIR)
  • IEEE Working Group P2933 Biodata: Trust, Identity, Privacy, Protection, Safety & Security for Clinical IoT