Regulatory Complications with Spare Parts

In the world of Electrical and Electronic Equipment (EEE), regulatory requirements are complicated, confusing and seemingly ever changing. For this article, I will be explaining requirements for laboratory equipment, industrial control equipment and measurement equipment. To satisfy both the electromechanical safety (shock, Fire, mechanical hazards) and electromagnetic compatibility (incoming and outgoing magnetic radiation) requirements for most global markets, we must comply with EC61010-1 and IEC61326-1 respectfully.

It goes without saying that EEE products are made up of many subcomponents, specific modules and accessories. When the overall product is certified to the standards mentioned above, all of these parts are reviewed together in their fully operational function and intended use. These end product certifications verify that the product was designed in a proper manor to be safe and allow all parts to work in harmony.

When the product ships worldwide, the Authorities Having Jurisdiction (AHJ) will review the products Harmonized Shipping (HS) code to let them know what certifications should be present with said shipment. The HS code is a globally accepted shipping code that helps the authorities and other shipping agencies know “what’s in the box” without opening it. If the HS code says the product is a medical device, there are certain registrations and certifications necessary. If the HS code says the product is a personal computer, different registrations and certifications are needed. What we will discuss today is what happens when product modules, spare parts and accessories are shipped separately thus generating a different HS code and triggering the need for different certifications.

An issue that has been giving many manufacturers in this space some trouble is when the AHJ’s ask for registrations or certifications for spare parts and accessories shipped separately from their main unit. When this occurs, there are generally two options. The first option is when an accessory requires separate certification to be sold. If the accessory item can be connected to other equipment, whether the manufacturer part of not, said part will need its own certification and registrations. This is because the part could indeed be used in various other types of EEE and must be evaluated to its own low level compliance standards.

To explain this on a more technical level, when a finished EEE product that can complete an intended use function with the use of electrical power is evaluated against its associated compliance standard, the compliance engineer reviews things such as current draw, input voltages, shock and mechanical hazards. With that said, even during this type of evaluation the individual components or modules inside the EEE are not extensively tested because the overall product passes its requirements. These passing results seemingly prove that that the products design was done in a way that reduces most of the major hazards with things such as fuses, EMC filters, and other safety features which were constructed and assembled together.

When you remove one these modules to sell separately and/or as a spare part you are essentially removing them from their original design and other related components/modules. This means that the fuse or EMC filter or safety feature that was once in series with this module is no longer there. This is why said modules or spare parts are required to be reviewed separately and be subsequently certified or “recognized”; a term associated with the Nationally Recognized Testing Laboratories (NRTL’s) within North America.

Now that we understand why some spare parts and modules require their own registrations and certifications, we can talk about the easier second option. If a module or spare part is specifically “keyed” or designed in a way that it can only be used within a single manufacturers product, then the manufacturer should inform the AHJ of this and ask that the overall products certification cover said component or module seeing as though the module or spare part cannot operate on its own in any function without the larger system it plugs into. Now this is not a guaranteed solution, but most of the time, this is a reasonable enough technical conclusion that it should help streamline the issues at hand if and when they arise.

To take the above discussion into a real-world example, let’s look at the Eurasia Economic Union (EAEU) region and their requirements. This region requires a Eurasian Conformity (EAC) marking proving Electrical and Electronic Equipment (EEE), spare parts, accessories and consumables meet the applicable regulations for that region before commercial sale is allowed. 

Like most things related to regulatory, EAEU regulations have their complications as well. When shipping/selling spare parts for repair; meaning the same exact part replacing an existing broken part for the purpose of maintaining and restoring the full functionality of the EEE, the EAC conformity mark is not required. On the other hand, when accessories are distributed/imported for resale purposes to the end user the EAC marking does apply.

Components and spare parts that most always require their own certification or registrations are things like appliance power cords, external power supply “bricks” or “wall warts”, personal computers and their related accessories and various other items as well. This isn’t always a black and white topic but this article is meant to give you a basic idea of why things are the way they are. Always remember that language barriers, interpretation of the law and “grape vine effect” will always play a part when dealing with global importation and distribution as it relates to law and regulatory. The best thing to do in these type of situations would be to reach out to your internal Electrical and Electronic Equipment (EEE) regulatory expert or as a secondary option, a third party globally recognized certification house like Intertek, UL, CSA or TUV.

Author: Brett

Brett Gagnon is currently one of the global subject matter expert for electrical equipment and electrical medical devices at Merck KGaA Darmstadt Germany, otherwise known as Millipore Sigma within North America. He has an Electrical Engineering degree from Wentworth Institute of Technology and a Masters of Business from Southern New Hampshire University. Mr Gagnon has a background in the ATIC (Assurance Testing Inspection Certification) industry based on previous years working for Intertek Testing Services NA Inc out of the Boston Ma area. During his time at Intertek he became a CB certified engineer evaluating products to medical, laboratory, IT, and Industrial standards. He also has a knowledge base in laser, Ingress Protection testing and wireless radio registration. Additionally Mr. Gagnon was a Field label and Special Inspection agent reviewing large custom equipment for national safety approvals in North America.