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

Insights

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.

Doctors preparing a patient for MRI scan in hospital.

By Clare Naden on

Improving the safety of medical devices

Reducing and managing risks related to medical devices is the objective of a key industry standard, ISO 14971. Detailed guidance to optimize its use has just been updated.

Top standards

Standard
ISO 15223-1:2021
Medical devices
Symbols to be used with information to be supplied by the manufacturer

Part 1: General requirements

Published
Standard
ISO 13485:2016
Medical devices
Quality management systems

Requirements for regulatory purposes

Published
Standard
ISO 14971:2019
Medical devices
Application of risk management to medical devices
Published
  2. Sectors
  3. Health
  4. Equipment