For New Technologies – Like 3D Printers – What Product Safety Standard Applies?

Product safety compliance for equipment that falls into an established product category is straightforward.  But what about new technologies – how are these products evaluated? 

As a case example, let’s look at 3D printers.  3D printers aren’t new, but they are just now entering the mainstream, with many more manufacturers developing new small desktop versions for consumers or larger industrial versions for businesses.  Also called additive manufacturing or rapid prototyping, 3D printing is the process of using specialized equipment to build a physical object from a three-dimensional digital model, typically by layering many successive thin layers of a material, such as plastic polymers or powdered metal or even food ingredients.

This post contains guidelines for selecting the appropriate safety standards for equipment associated with 3D printing and additive manufacturing, and can serve as an example for other new technology products that can’t be easily categorized.

The intent is to associate 3D printing and additive manufacturing equipment with relevant, existing safety standards for the various current uses of this technology, including commercial, consumer, food processing and medical equipment.  Generally, existing standards that cover similar types of equipment used in similar operating environments may be used for equipment associated with additive manufacturing.

Here are the standards that cover 3D printing and additive manufacturing equipment for various potential uses:

Home/Commercial
International: IEC 60950-1 Safety of ITE or IEC 62368-1 Safety of AV & ICT Equipment
US: UL 60950-1 Safety of ITE or UL 62368-1 Safety of AV & ICT Equipment
EU: Low Voltage (LV), 2006/95/EC, 2014/35/EU

Food Preparation – Household
International: IEC 60335-2-14 Kitchen Machines
US: UL 982 Motor-Operated Household Food Preparing Machines
EU: Low Voltage (LV), 2006/95/EC, 2014/35/EU

Food Preparation – Commercial
International: IEC 60335-2-64 Safety of Commercial Electric Kitchen Machines
US: UL 763 Motor-Operated Commercial Food Preparing Machines
EU: Low Voltage (LV), 2006/95/EC, 2014/35/EU

Medical
International: IEC 60601-1 Medical Electrical Equipment
US: ANSI/AAMI ES60601-1 Medical Electrical Equipment
EU: Medical Devices (MDD), 93/42/EEC

When the equipment involves technologies, materials or methods of construction not specifically covered by the standard, the equipment should provide safeguards not less than that generally afforded by the applicable standard and the principles of hazard-based safety engineering, as found in standards like IEC 62368-1.

Of course, there are additional compliance requirements for electromagnetic compatibility (EMC) – FCC & Industry Canada in North America, the EMC Directive in the EU, and other EMC requirements around the world. 

Contact MET, a leading 3rd party test laboratory, to determine what requirements apply to your equipment.