Risk Management has been considered a critical factor in the revised IEC 60601-1 Third Edition. Not only does the new standard require that Risk Management be implemented in the product lifecycle throughout; it also requires complete adherence to ISO 14971, the ISO standard on risk management in medical devices.
“Essential Performance vs. Basic Performance”
Another crucial component of IEC 60601-1 Third Edition is that it makes safety an “Essential Performance”. This is change from the earlier version, in which required only “Basic Safety”. Essential Performance is that aspect of the medical device’s performance that has a direct bearing on the device’s safety. It requires evaluation in accordance with ISO 14971. According to this amendment, Essential Performance is performance, other than that related to Basic Safety, whose loss or degradation beyond the limits specified by the manufacturer results in unacceptable risk.
Clause 4.3 of IEC 60601-1 Third Edition is the normative guide to Essential Performance requirements under IEC 60601-1 Third Edition. It states that “The manufacturer shall identify which functions of the ME equipment and ME systems (the 2012 amendment adds Medical Software Systems to this list) are essential performance.” So, where this standard specifies that Essential Performance is to be maintained following a specific test; the functions determined above (using Risk Management) shall be used and compliance shall be checked by inspection, and if necessary, by functional test.
- The manufacturer has to define Essential Performance in accordance with manufacturer’s policy for Risk acceptability
- Essential Performance cannot be identified where there is no part-two standard
- Both the General Standard and the new EMC standard define Essential Performance as part of the Risk Analysis Process
- Essential Performance must thus be identified each time a Risk Analysis is performed
- Diagnostic functions essentially qualify as Essential Performance
- Monitoring does not fall under Essential Performance, but alarms need to be given
- Loss of function for surgical devices is usually Essential Performance because they need to be re-anaesthetized
- Loss of most alarm functions is usually Essential Performance.
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