ISO - Health

ISO standards on healthcare enhance patient safety, help streamline supply chains, and foster innovation in digital health and sustainable healthcare solutions.

Top standards

ISO 10993-1

Biological evaluation of medical devices

Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

Published in 2025

CHF 177

ISO/IEC 29138-1

Information technology — User interface accessibility

Part 1: User accessibility needs

Reviewed in 2024

CHF 0

ISO/IEC TR 29138-2

Information technology — Accessibility considerations for people with disabilities

Part 2: Standards inventory

Published in 2009

CHF 0

ISO 15223-1

Medical devices — Symbols to be used with information to be supplied by the manufacturer

Part 1: General requirements

Published in 2021

CHF 177

ISO 13485

Medical devices — Quality management systems — Requirements for regulatory purposes

Reviewed in 2025

CHF 177

ISO 10993-12

Biological evaluation of medical devices

Part 12: Sample preparation and reference materials

Published in 2021

CHF 132

ISO 14644-5

Cleanrooms and associated controlled environments

Part 5: Operations

Published in 2025

CHF 132

Insights

Healthcare cybersecurity: Diagnosing risks, prescribing solutions

Cyber-attacks can severely impact personal lives and put patients at risk of harm. That’s why cybersecurity is vital for healthcare organizations to protect patient wellbeing and privacy at all times.

Healthcare’s digital transformation: Telemedicine, data protection and cybersecurity

Health is what we all have in common. When it’s protected, it empowers people to prosper; but when it’s neglected, it can have devastating consequences, not just for individuals but for entire communities.

Healthcare management: Delivering quality to the health industry

ISO 7101, the world’s first-ever standard on managing quality in healthcare organizations, provides much needed guidance for a rapidly evolving sector.