ISO Issues Risk Management Standard for Devices

The International Organization for Standardization (ISO) has released a standard for device manufacturers for assessing and controlling potential medical device hazards.

The standard covers hazards related to usability, electricity, biocompatibility, moving parts, data and systems security and radiation, and is applicable to all phases of a device’s life cycle, ISO said.

Manufacturers don’t need to follow the ISO standard in their quality management system, but they are required to use objective criteria for assessing risk.