IEC 60601-1-4 New April 2000 Consolidated Version

“Medical electrical equipment – Part 1: General requirements for safety – 4. Collateral standard: Programmable electrical medical systems”. Originally iIssued in May of 1996 and amended in 1999 this standard defines an approach to risk management for programmable medical devices. In April 2000 IEC released a consolidated version of the 1996 original and 1999 amendment with change bars and also numbering based on the general 601 standard. FDA based some of their software hazard management concepts on this standard although FDA did not recognize it as a software standard it did recognize it for risk analysis in a limited way. The “as low as reasonably practicable” (ALARP) concept in this standard is a good concept to be familiar with.
This standard can be ordered directly from the IEC at the link provided. Just go to their web store page and search on 60601-1-4. The standard can be ordered as a hard copy or an adobe pdf file.

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Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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