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Standards Development
This document specifies the requirements for the basic safety of medical electrical equipment with respect to exposure to electromagnetic fields. The requirements reflect the current thinking of SC 62A/WG 47, taking into consideration IEC Guide 124 on elec tromagnetic exposure assessment methods. These requirements are being made available for real-world testing to facilitate development and consolidation in the future Edition 4 of IEC 60601-1. Therefore, this document is not establishing a new level of sta te of the art.
This document can be applied to sub-assemblies of medical electrical equipment.
This document does not apply to:
- in vitro diagnostic medical device that does not fall within the definition of medical electrical equipment, which is covered by the IEC 61010 series;
- implantable parts of active implantable medical devices covered by the ISO 14708 series; or
- medical gas pipeline systems covered by ISO 7396-1
IEC SC 62A/WG 47 is responsible for development of a clause for IEC 60601 -1 Edition 4 (62A/1582/RR), which has reached a sufficient level of maturity to publish its content for practical use by all stakeholders.
At the meeting of IEC TC62 in Milan, the national committees have tasked WG 47 to prepare an NP for publication of the current content as a Technical Specification (62A/1707/DL Decision 14). The purpose of this TS is to enable all stakeholders to review and apply the newly developed requirements and provide feedback to WG 47 prior to release of the merged CDV for 4th Edition (currently anticipated for 2029). Timely publication and wide availability will allow to catch any issues that would otherwise only su rface after final publication.
A working draft for the TS is attached to this NP, which reflects the status of IEC 60601 -1/FRAG11 ED4, circulated on 2025-06-06 as 62A/1666/CD ("CD2"), and incorporating changes based on NC comments (62A/1689/CC).
Notably, structure and content was substantially updated based on comments received from the National Committees, and NCs are invited to carefully review the attached WD and provide improvement suggestions together with the vote concerning the NP.
The NP concerns a document outside the IEC 60601 series to clarify that its content does not replace or augment requirements in IEC 60601-1 Ed 3.2, nor does it claim sufficient maturity to be interpreted as a next level of state of the art."
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