Certified materials are particularly important for the food industry and medical technology. These are for example EU10/2011, FDA approvals, ISO 10993, RoHS, REACH and UL94 certifications. Learn more about the certificates and the tested materials you can get at Jellypipe in this article.
In the food industry, 3D printing enables the production of components from food-safe polymers. Requirements such as a blue color, increased impact strength, temperature resistance precisely adapted to the respective requirement or optimized sliding and wear behavior are covered by the various materials.
Additive manufacturing is also increasingly being used in the demanding fields of medical technology. Great design freedom, maximum functional integration and individual designs open up completely new, innovative treatment approaches in the manufacture of dental prostheses, in orthopedic technology or in prosthetics.
The application safety of the materials used is defined by standards and regulations. Find out in this article which certified materials Jellypipe can provide for 3D printing in the food industry and medical technology.
Materials used in handling food must not have any harmful effects when in contact with food or beverages. All contamination - for example, through spalling or the introduction of germs - must be avoided as far as possible. The transfer of particles from the material to a food product must also be prevented.
The suitability of materials in the field of additive manufacturing for the food industry is often indicated by FDA approval. The Food and Drug Administration (FDA) is a U.S. agency that is responsible for monitoring the market for food, medical devices and drugs. The FDA decides whether and which materials may be used when handling food.
FDA approval is roughly equivalent to the European Regulation EU10/2011 on plastics for food contact, but with one major difference: FDA certification is not binding for products manufactured in Germany or Europe.
The situation is different, however, if products from Germany or Europe are to be exported to the USA. In this case, any product that is or may be in direct contact with food requires appropriate certification by the FDA. This applies to machines in food production as well as to tools or containers. Even the smallest accessories - which are now frequently produced via 3D printing - are subject to the strict requirements of the FDA. It is therefore clear that the FDA is also very relevant in the food industry sector in Germany and Europe.
At Jellypipe you will find a wide range of materials with FDA approval for 3D printing. We recommend the following materials for additive manufacturing components for the food industry:
Picture: PA11 blue through-feed component
In the food industry, materials are required that can be used safely even at the highest temperatures. The UL94 standard issued by Underwriters Laboratories, an independent testing organization, certifies materials that are designed to be flame retardant. At Jellypipe, the following materials are certified to UL94:
Image: Certified materials are required for hot temperatures in the food industry.
Medical products used on the human body must not have any negative effects on tissue, reproductive capacity or genetic material. All natural or synthetic substances that come into contact with the human organism as a medical product are therefore subjected to extensive testing. The focus is on biocompatibility on the one hand and biotoxicity on the other.
The term biocompatibility covers material characteristics that must be fulfilled for a very specific application. In the case of prostheses, for example, this can be high strength and durability, the possibility of sterilizability, or precisely defined pliability. The surface structure or density of a medical product are also defined in the area of biocompatibility.
Biotoxicity, on the other hand, deals with the materials in terms of possible damage to tissue or cells. Extensive testing and inspection procedures ensure that the materials used have no negative effects on cell metabolism or growth. The safety of materials for 3D printing of medical products is tested according to European norms (EN) or international standards (ISO) , suitable materials receive certification according to DIN EN ISO standards. The US counterpart - United States Pharmacopeia - works with similar standards, but here they are called USP Class.
Materials used in additive manufacturing for medical devices are tested using DIN EN ISO 10993. The catalog of standards consists of 20 sublabels, for example DIN EN ISO 10993-5, in which materials are tested for in vitro cytotoxicity. If a material meets the strict requirements of the standards catalog, it is certified and thus approved for use in medical technology.
The certification of materials in the USA works in a similar way to the European EN ISO standards catalog. However, the US system works with a division into classes. USP Class 1 is the loosest class, USP Class 6 the strictest. Plastics classified in USP Class 6 offer the best possible biocompatibility. The classification of materials according to USP Class is usually seen as a minimum requirement in the field of biocompatibility. Internationally, the much stricter ISO 10993 standard is increasingly gaining acceptance.
At Jellypipe, materials are available for 3D printing that are used in medical technology but are used outside the body. Approval according to DIN EN ISO 10993 is offered by the following materials:
In the field of additive manufacturing for medical technology or the food industry, products and their individual components are subject to further standards, compliance with which is intended to prevent the use of hazardous substances that are harmful to the environment or difficult to dispose of. The RoHS (Restriction of certain Hazardous Substances) certificate confirms that an electrical device or electronic component contains less than 0.1% of hazardous substances that are harmful to the environment or difficult to dispose of. Only products that have this certificate may be sold within the EU and bear the CE mark. At Jellypipe, the following materials have RoHS certificates:
With the REACH regulation, the European Union wants to improve the "protection of human health and the environment from the risks that can be caused by chemicals". In this context, REACH applies to all chemical substances - and therefore also to the materials used in 3D printing. At Jellypipe, the following materials comply with REACH:
Do you have any questions about our materials or would you like to discuss a specific project in the field of medical technology or food industry with us? Then please contact us right away!
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