IEC 61010-1 Certification Requirements, and External Supply/ELV questions

B

bruj02

Dear Cove,

I am new to the world of compliance and certification. Over the past few days, I have done a lot of research, met or spoken to representatives from various NRTLs, and scoured this forum for answers.
I would first like to express my gratitude, as I have found lots of useful info here. However, I still have lots of unanswered questions, and would really appreciate your input to confirm my some of my findings and and answer some questions.

Background:
We manufacture very specialized laboratory equipment, in low quantities. We intend on selling this equipment throughout the world. Major markets are U.S., Europe, Asia and Canada.
According to an evaluation by TUV SUD America, the product we are building falls under 61010-1, a harmonized standard. This is a good thing because UL/CSA/IEC all work with the same guidelines and requirements. We could even obtain a CB scheme, a type of Certification passport to makes it easier to recognize the certification across the world.
We designed the product to work off an external power supply, 24VDC - 220W. The external supply has all the certifications (UL, TUV, CE, ETL) We chose to work with an external AC/DC adapter to facilitate safety compliance.
The only reason we are interested in certification is for safety/legal reasons. I mention this because I feel that many people have tried to mislead us into believing that product certification is required for sale in the US/Canada, while other have told us that, since our input is extra low voltage, certification was optional. I understand that a UL mark can be a good tool for marketing purposes, or that WalMart will not accept non-UL-Listed parts, but this do not apply to our product and market context.
I also understand that compliance is necessary for sale in Europe, but it's my understanding that the cost can be minimized by performing some of the work in-house (as opposed to a certification mark by NTRLs)

Findings to be confirmed

External supply and compliance in the U.S. and Canada
Since we use a 24VDC external supply, we can claim that our device operates at an extra-low voltage. Since the external supply is UL-listed, it can legally be plugged into an Outlet in the U.S. or Canada, without having to certify the system as a whole - is this correct?

External supply and compliance in Europe/CE mark
I understand that CE is self-certification. We must therefore show that we comply with the relevant directives. In our case, these are EMC/EMI requirements (EN 61326-1) and the low voltage directive. The EMC tests will be conducted at a local lab, where they will issue a report which we can use as part of a technical file to show compliance. For safety compliance, we can produce a report ourselves to show that we meet all of the 61010-1 requirements. Since the power supply is external, we don't need to do any high potential (HiPot) tests or fire hazard tests. However, we still need to produce a report, and show that moving parts will not hurt the user. Is this correct?

Questions which I cannot find answers for

Hazardous energy level - 240VA?
Ok, we we use an extra low voltage, this should make the product safer for electrical/fire hazards. But the SELV also has a maximum energy requirement (240VA). The manufacturer of our power supply states that:
CF1.5 The following secondary output circuits are SELV: All
CF1.6 The following secondary output circuits are at hazardous energy levels: All
Does this mean that are device can pose risks to the user? Can we eliminate these risks without having to certify the product with an NRTL (CSA, UL, ETL, ...)?


ELV/SELV/PELV/FELV...and earthing
Our device operates on extra low voltage, which should make it safer. However, our enclosure is grounded, to increase tolerance to electro static discharge. According to Wikipedia:
the safety of the SELV circuit is provided by [...]the lack of a return path through earth (ground) that electric current could take in case of contact with a human body.
So, we might not be a SELV device. But we could be a PELV...How does this affect safety compliance?


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Sorry for the lenghty post, but I thought that keeping all of it together might provide clear answers for someone who is as confused as I am.
Thank you very much in advance for the feedback and support.

David
 

Marc

Fully vaccinated are you?
Leader
Another quick "Bump". My Thanks in advance to anyone who can help with this one.
 
B

bruj02

Ok.. I will give this one final bump in the hopes that someone can answer. I really can't believe how difficult it is to find answers in the certification world.

Please help me if you can - I would really appreciate it. Thanks,
 
W

w_grunfeld

The IEC define an ELV circuit as one in which the electrical potential of any conductor against earth (ground) is not more than either 25 volts RMS (35 volts peak) for alternating current, or ripple-free 60 volts for direct current under dry conditions.
A SELV circuit must have:
protective-separation (i.e., double insulation, reinforced insulation or protective screening) from all circuits other than SELV and PELV (i.e., all circuits that might carry higher voltages)
simple separation from other SELV systems, from PELV systems and from earth (ground).
For CE it is self-declaration but you need a third party accredited lab (not necessarily NLTR!) to perform type certification tests for compliance to 61010-1 and EMC, as part as your technical file, as well as a user manual complying with the standard's requirement.
Theoretically you could perform all the required tests in house, but it's doubtful you would have the required test equipment, know-how and procedures. Besides upon request, you should be able to present test reports that would be recognized by others
Hope this helps
 
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