We will evaluate the aspects of 3D printers that we have started to see the impact in every sector by increasing the use area, developing design and manufacturing possibilities.
Is there any applicable EU legal framework for 3D printers?
3D printers, also known as “Additional Production” machines, are the production tools that can be used to produce many products in the ever increasing variety. We heard about the news that some products that are urgently needed during the pandemi period are produced with 3D printers. Based on 3D printers are among the “condiumized products” defined in the EU.
First, they enter the “machine” definition within the 2006/42/AT Machine Safety Regulation. For this reason, manufacturers must ensure compliance of the “Machine Safety Regulation of 3D Printers, create a technical file and to provide them with CE marking before presenting them to the EU market.
The CE mark shows that the product is designed and manufactured in accordance with the Machine Safety Regulation 2006/42/AT. These products can be freely circulated in the market and EU member states do not require additional requirements for the introduction of such products to the market.
Are there mandatory EU standards for 3D printers?
Regarding 3D printer, the machine manufacturer or authorized representative must ensure that a risk assessment is performed to determine the health and safety requirements applied to the machine.
The machines should then be designed and manufactured by considering the results of such risk assessment.
The Machine Safety Regulation 2006/42/AT reveals “amel requirements” for the health, safety and performance of the products they cover. However, this EU does not recommend any special mandatory technical solution for the design of legal frame products. Therefore, 3The manufacturers of D printers can be used in the technical solution they choose to meet “amel requirements”.
Manufacturers can find certain technical solutions, which are published in the Official Gazette of the European Union, in accordance with the European standards or in their parts, in detail. If the manufacturer chooses to adopt this kind of technical solution, it is assumed that the product is suitable for basic health, safety and performance requirements.
If the manufacturer prefers to adopt another technical solution, then in the technical file, this technical solution should give a detailed description of the EU legislation requirements.
Is there harmonized standards for 3D printers?
For laser-based 3D printers, some of the relevant harmonised standards specified in the European Union Official Gazette are:
- EN ISO 12100 (Machine safety – General principles for design – Risk assessment and risk reduction)
- EN 60204-1 (Machine safety – Electrical equipment of machinery)
- EN 13849-1 (Machine security – parts related to the security of control systems)
- EN 13850 (Machine safety – Emergency stop function – Design principles)
- EN ISO 11553-1 (Laser processing machines)
- EN 1127-1 (Patifying environments – Prevention and protection of the explosion)
- EN ISO 19353 (Machine safety – Fire protection and fire protection)
- Fire and explosion standards are also important for plastic printers. In addition, it is useful to consider some unmatched standards for laser products / safety;
- EN 60825-1 (Laser products safety – Part 1: Equipment classification and requirements)
- EN 60825-4 (Laser products safety – Section 4: Laser protections)