IEC/TR 62348 is a technical report that assesses “the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition.” The report is intended to be a tool for manufacturers to understand the impact of Amendment 1:2012 changes to 60601-1 from the 2005 version.
From a software perspective, the report indicates “moderate impact” related to section 14 Programmable Electrical Medical Systems or PEMS. The 2005 update to IEC 60601-1 specified that a “development process” is required for all Programmable Electronic Subsystems (PESS) including software. That update included informative references to IEC 62304 for information on software since 62304 was soon to be released at that time. For manufacturers that incorporated full IEC 62304 compliance into their development process, amendment 1 creates no additional requirements. If a development process was put into place but it was not fully compliant with IEC 62304, conformance with amendment 1 will require full compliance with IEC 62304.
We would further remind our clients of the specific requirements for software risk analysis required by 62304 as this may not have been explicit in the existing risk management policies and procedures.