IEC 62368-1 Scope of Testing

Harsh

Involved In Discussions
#1
Hello Everyone,

I was wondering about the requirement for safety testing of the product according to IEC 62368-1. The company I work for manufacture lab devices like Centrifuge, Vortex mixer, etc. Currently, our R&D team is working on a new project of development of a CO2 Incubator.

As the CO2 incubator is also a lab device, I thought the IEC 61010 series of standards would suffice the need for EC declaration regarding safety. But I got confused when I observed IEC 62368-1 standard present in the EC Declaration of one of our competitors. If the incubator contains USB & ethernet ports then would it be mandatory to opt for IEC 62368-1 instead of the IEC 61010-1 standard? Or the product should be tested according to both standards? Also, would there be any additional testing required for EMC except according to the IEC 61326-1 standard?

Please advise.

Thanks in advance.
 
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CharlieUK

Quite Involved in Discussions
#2
The best approach is to look at the primary function of the product - for example, a washing machine or slow cooker do not suddenly fall under EN 62368-1 just because they have a WiFi radio in them - they remain domestic appliances under 60335 series of standards

Your equipment is laboratory equipment, and I would recommend applying 61010-1 along with any applicable -2 standard

USB and Ethernet ports are considered to be SELV ports in EN 62368-1 so you must ensure that they are treated as accessible circuits in your product.

I would suggest that your competitors have not chosen the most appropriate standard (though there's no reason why the products should not be safe provided that 62368-1 has been properly applied)
 

CharlieUK

Quite Involved in Discussions
#4
Consider them to be an "accessible part" in section 6.5.1 (Figure 4) and isolated from AC mains supply, and other hazardous circuits, accordingly
 
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