ISO 14971 - Risk Acceptability

01 August 2011

During the July 11 blog, we explored the aspects of risk analysis and risk estimation. But what is a risk that is deemed unacceptable?

If a risk is determined to be unacceptable, the existing risk analysis should be re-examined and the appropriate action(s) taken to meet the risk acceptability criteria. If a new hazard is identified, the four phases of risk management should be performed to ensure that the risk is being adequately controlled.

For risks that cannot be mitigated, ISO 14971 Annex J provides guidance on communicating risk. Manufacturers should explain each risk, its consequences, and how to prevent it, as well as who should receive that information and how the risk information should be disseminated. Remember that information for safety such as warning labels and guides should be your last resort. The priority order is:

  1. inherent safety by design
  2. protective measures (to reduce hazards from intended use and foreseeable misuse)
  3. safety information

To learn more and/or to speak with an Intertek expert on this subject matter, e-mail us at askmedical@intertek.com or visit www.intertek.com/medical/.