rothlis
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The fifth paragraph of IEC 60601-1/A1:2012 clause 8.5.1.3 specifies the requirements for each means of protection (MOP). The third bullet point says "components that are connected in parallel with an insulation, with an AIR CLEARANCE or with a CREEPAGE DISTANCE comply with 4.8 and 8.10.1".
Compliance with clause 4.8 means that it is used within its rated levels and, if there are relevant standards for the component, then the component should show compliance, or if there are specific clauses in the standard for that component (e.g., transformers per 15.5.3) then those clauses need to be met. In all other cases the standard says that "any other applicable source (e.g. standards for other types of devices, national standards) could be used to demonstrate compliance with the RISK MANAGEMENT PROCESS".
For this latter case, I am interpreting the standard to allow components to participate in the MOP so long as they are acting as a MOP within their rated levels and are securely fixed.
For example, a transistor on a PCB can be part of the MOP for a 5V, 1A path if:
Is this a correct interpretation? If not, what is the proper response to the conjunction of the third bullet in 8.5.1.3 and clause 4.8 when there aren't any specific standards or clauses addressing a type of component?
Compliance with clause 4.8 means that it is used within its rated levels and, if there are relevant standards for the component, then the component should show compliance, or if there are specific clauses in the standard for that component (e.g., transformers per 15.5.3) then those clauses need to be met. In all other cases the standard says that "any other applicable source (e.g. standards for other types of devices, national standards) could be used to demonstrate compliance with the RISK MANAGEMENT PROCESS".
For this latter case, I am interpreting the standard to allow components to participate in the MOP so long as they are acting as a MOP within their rated levels and are securely fixed.
For example, a transistor on a PCB can be part of the MOP for a 5V, 1A path if:
- The pads and pins for the relevant nodes are spaced to meet the clearance requirement (e.g., 0.8mm, using air clearance per clause 8.9.1.3).
- The transistor is rated to at least 5V and 1A.
- The transistor is adequately fixed (e.g., soldered to PCB).
- The resulting leakage current falls below the limits.
Is this a correct interpretation? If not, what is the proper response to the conjunction of the third bullet in 8.5.1.3 and clause 4.8 when there aren't any specific standards or clauses addressing a type of component?
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