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.

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

  1. As all FFF printers have heated nozzles and some have heated buildplatforms they do not comply with 2006/95/EC but must comply with 2006/42/CE.
    At this point we only know of 1 machine that does. nudge nudge wink wink.

    • MDW MDW

      This comment re the EU 2006/95/EC (Low Voltage Directive – LVD) and 2006/42/CE (Machinery Directive – MD) is not strictly correct. As is usual with compliance (and engineering in general) actually the correct stance is ‘it depends’. The ‘fused filament fabrication'(FFF) printer is usually marketed as a ‘desktop’ piece of equipment which would or could be intended for ‘household use’. Certain specific types of equipment which fit the definition of machinery but are also within the scope of the LVD are excluded from the MD on the grounds that the risks they present are mainly electrical in nature. These include “ordinary office machinery” and “household appliances for domestic use”.

      It is prudent to apply ‘state of the art’ and therefore adhere to the principles of BOTH the MD and LVD with regards the design and compliance of a 3D printer which may be used by both consumer and business. The appropriate product standards will list limits for temperature and exposure for end-users. IEC 62368-1 Safety of AV & ICT Equipment with its hazard based safety engineering 3 block model is also a better fit for these products.

      Which directive is listed in the Declaration of Conformity will then depend on the environment in which the unit will be used – i.e. it depends!

      HTH – MDW.

  2. All FFF type printers must comply to MD and may not comply to LVD because of annex1-2-(b) in the LVD

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