Functional Safety Certification for Powered Prosthetics: ISO/IEC 42001 Explained

Date
2027-02-12
Location
Online
Host
Zach L

About this event

A Tabletop Exercise for Regulatory Affairs Specialists pursuing functional safety certification. A live 30-minute tabletop exercise on ISO/IEC 42001 (AI Management Systems) for powered prosthetics, built for regulatory affairs specialists pursuing functional safety certification. What We'll Cover: What ISO/IEC 42001 (AI Management Systems) requires and how its scope applies to powered prosthetics Mapping ISO/IEC 42001 clauses to the certification evidence assessors expect System-specific hazards and safety functions typical of powered prosthetics Common findings that delay certification, and how to avoid them A practical readiness roadmap for regulatory affairs specialists preparing for assessment Related topics: ISO/IEC 42001 · Powered Prosthetics · functional safety certification · funct

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About ISO/IEC 42001 (AI Management Systems)

This event covers the compliance, engineering, and verification requirements defined by ISO/IEC 42001.

ISO/IEC 42001 specifies requirements for an AI management system (AIMS) — the organizational policies, roles, processes and controls for developing or using AI responsibly, analogous to ISO 9001 for quality or ISO 27001 for security.

What it regulates

Organizational governance of AI: risk and impact assessment, data governance, lifecycle controls, transparency, human oversight, supplier management, and continual improvement, with an Annex A control set.

Who must comply

Organizations building, deploying or procuring AI systems that want auditable governance — including industrial companies embedding AI in products and services subject to regulations such as the EU AI Act.

Key requirements of ISO/IEC 42001

  • Context, leadership, planning and support requirements (harmonized structure)
  • AI risk assessment and AI system impact assessment
  • Operational controls across the AI lifecycle (Annex A/B controls and guidance)
  • Performance evaluation, internal audit, and management review

Key concepts: ISO/IEC 42001

AI impact assessment
Structured evaluation of consequences of AI systems on individuals, groups and society, feeding controls.
AIMS
The management system scoping which AI systems, roles, and lifecycle stages the organization governs.
Data governance for AI
Controls on provenance, quality, representativeness and lawful use of training and operational data.
Human oversight controls
Mechanisms ensuring meaningful human ability to monitor, intervene in, or reverse AI behavior.

Frequently asked questions: ISO/IEC 42001

Does 42001 make AI products safe by itself?

No — it governs the organization. Product-level safety still requires engineering standards (IEC 61508 family, TR 5469, sector standards); 42001 provides the management framework those activities run inside.

Is ISO/IEC 42001 certifiable?

Yes, it is a certifiable management system standard; accredited bodies audit organizations against it like ISO 9001 or 27001.

Standard information based on the published text of ISO/IEC 42001 (AI Management Systems). Event content is provided by the host. For authoritative guidance, consult the official standard body.