SoftwareCPR comments on common confusion:
Struggling with Essential Requirements? Many manufacturers faced with compliance to the 3rd edition of 60601-1 do not understand which of their product requirements meet the essential requirements definition. Confusion arises over the actual risk control measures designed into the system and the requirements for the “performance of a clinical function where loss or degradation beyond the limits specified by the manufacturer results in an unacceptable risk”. Specifying these limits is the key to understanding essential requirements.
For example, if essential performance states that “XYZ pressure must be maintained within a safe range throughout the treatment”:
– Do requirements show clearly what the safe range is, and how monitoring and control are performed?
– Does the hazard analysis correctly align with the failure of essential performance?
– Are the related parameters (in this case, safe range limit values) consistent through safety analysis, requirements, and test?
– If timing is critical, is it addressed wherever appropriate, including essential performance (possibly pressure spikes are acceptable, if of short duration)?
Oversights and inconsistencies are commonly observed when cross-checking these device design elements. Seems obvious and straightforward, but when the issues are scattered throughout a complex risk management file, they are more difficult to see and correct. Maintaining a consistent and organized story as the design decomposes into greater detail will help to avoid confusion and effectively communicate the device performance to different audiences.
If you need help with IEC 60601-1 3rd Edition or related standards such as IEC 62304 or 62366 call 781-721-2921 US or leave a message on our site and one of our experts will contact you.