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 10993-7

Biological evaluation of medical devices

Part 7: Ethylene oxide sterilization residuals

Published in 2026

CHF 227

ISO 14155

Clinical investigation of medical devices for human subjects — Good clinical practice

Published in 2026

CHF 227

ISO 20417

Medical devices — Information to be supplied by the manufacturer

Published in 2026

CHF 225

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 196

ISO 10993-6

Biological evaluation of medical devices

Part 6: Tests for local effects after implantation

Published in 2026

CHF 196

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 196

ISO 13485

Medical devices — Quality management systems — Requirements for regulatory purposes

Reviewed in 2025

CHF 196

Insights

Psychosocial health in the workplace: A critical factor for success

As OHS continues to evolve, it is becoming clear that how people experience work is just as important as how safely they perform it. Psychosocial health and well-being are increasingly recognized as a defining factor in how organizations perform and succeed over time.

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.