Reviewing Risk Management with IEC 60601-1

28 Mar 2011

IEC 60601-1 is intended to serve as a tool in the risk management process. This requirement is captured by clause 4.2, which specifies that risk management process shall be performed according to ISO 14971. But what does this mean with regards to certification and compliance? Translation: This means that certification to IEC 60601-1 is not possible without compliance with ISO 14971. However, certification to ISO 14971 is not required. A certificate for ISO 14971 is an asset, but it does not exempt the safety test lab from having to verify compliance on a product basis.

Now, the manufacturer is responsible for determining the acceptable level of risk. However, a third-party testing company is critical at this stage. Why? The manufactures can determine the acceptable level of risk, but the testing partner must be brought in to assess:

1. Whether the manufacturer's Risk Management Processes meet the requirements of ISO 14971;
2. That the manufacturer has followed the processes when completing Risk Management Plan for the Product; and
3. Risk Management File (RMF) address the requirements in the 60601 standards associated with risk.

Some elements of the RMF require more review time than others. Specifically, all elements that need to be reviewed by a third-party testing company (as they relate to 60601) need to meet the requirements of ISO 14971.

But what are these requirements? This topic will further be explored in a follow up blog on April 11.

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