Hi,
Does IEC 62368-1 Require 100% Electric Strength (Hipot) Testing?
IEC 62368-1 does not mandate 100% electric strength (hipot) testing for all 
units during production. Instead, the standard allows sampling based on a risk 
assessment, particularly for routine production testing.
Key Points:

  *
Type Testing: Performed representative samples during product certification to 
validate design compliance. This includes full dielectric strength testing.
  *
Routine Production Testing: Intended to detect manufacturing defects rather 
than revalidate insulation. Sampling is permitted based on a documented risk 
assessment and quality control procedures.
  *
Risk-Based Approach: The standard supports a hazard-based philosophy, allowing 
manufacturers to determine appropriate testing strategies (e.g., sampling vs. 
100%) depending on the risk level and production controls in place.
  *
Component Use: Certified components used within their rated conditions may not 
require additional hipot testing at the end-product level.

In summary, IEC 62368-1 allows for sampling in place of 100% testing, provided 
it is justified through risk assessment and quality management practices.

________________________________
From: John Woodgate <j...@woodjohn.uk>
Sent: Wednesday, April 23, 2025 10:52 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG <EMC-PSTC@LISTSERV.IEEE.ORG>
Subject: Re: [PSES] Electrical Strength Testing (Hipot)


IEC 62368-1 is about requirements. For testing products in production, you need 
to look at IEC 62911.

On 2025-04-23 15:25, Cecil Gittens wrote:
Hi All,

      Could you please confirm whether IEC 62368-1 requires 100% electric 
strength (hipot) testing for all products, or if sampling is allowed based on a 
risk assessment?

Regards,

Cecil Gittens
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