Standards Development

Scope

This document specifies requirements and provides guidelines for three key areas of non -medical BCI products that are entering or already available for purchase in the market:

a) Guidelines for minimum human testing requirements for commercialisation.

b) Protocols for post-market surveillance.

c) Standards for transparency in marketing.

These guidelines are intended to ensure that manufacturers inform all users about the scope of testing, known limitations, and potential long-term side effects.

Purpose

This specification is particularly relevant for developers and vendors of BCI technologies, as well as professionals who may recommend or refer these products as part of their professional roles (e.g., clinicians, therapists, human factors engineers, consultants, coaches, consumer advocacy groups, etc).

This technical specification excludes requirements relating to medical devices and also excludes BCI that only being used for academic research with no direct intent for commercialisation.

The document does not prescribe a complete risk-management system; manufacturers are expected to conduct such activities in accordance with [output of WG9 – security, safety, privacy and ethics], as well as ISO 14971, ISO 31000 or equivalent, and to docume nt how the resulting hazards, misuse scenarios and residual-risk targets inform the testing and surveillance activities specified herein.

If a country or region has regulations or guidelines related to this document, these will take precedence over this document.