Uncertainties in handling Risk Management
The integration of risk management requirements in the 3rd edition has created many unclear situations and discussions.
This is partly the result of the formulation of some of these risk management requirements and partly the result of the fact that a process standard, the ISO 14971, was integrated in a product standard, the IEC 60601-1. Soon after the introduction of the 3rd edition of the IEC 60601-1 and certainly when manufacturers and test houses started to ‘work’ with this standard these problems were reported. Partly, because of this situation work is in progress to formulate a 1st amendment for the IEC 60601-1, which certainly will address a number of the problems created earlier.
The publication of this 1st amendment is however still a few years away and till that moment manufacturers, test houses and regulatory bodies have to work together closely to ensure the overall safety of the medical devices.