ISO standards for medical equipment and devices ensure the highest levels of safety, performance, and reliability, from surgical instruments to diagnostic tools.

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.

A bioharad sharps container for used syringes.

Graphical symbols for medical devices

Leaving no room for error.

Close shot of a surgeon's gloved hand reaching for syringes on table.

New ISO standards for medical devices

Taking the headache out of regulations while improving product safety and performance.

Top standards

ISO 13485

Medical devices — Quality management systems — Requirements for regulatory purposes

Published in 2016
CHF 177
ISO 17665

Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

Published in 2024
CHF 221
ISO 14971

Medical devices — Application of risk management to medical devices

Published in 2019
CHF 177
  2. Sectors
  3. Health
  4. Equipment