All standard products from LINAK intended for use in electromedical equipment are certified according to EN IEC 60601-1, the international safety standard for medical electrical equipment.
At LINAK, we collaborate with one of the world’s largest and most recognised testing houses, UL International Demko in Denmark, ensuring that our products comply with the necessary medical standards. With our reports and certificates, we can document that the products have been thoroughly tested and meet the relevant requirements. John Kling, Regulatory Affairs Manager at LINAK A/S, explains:
“When customers submit a full application for approval, they can inform their testing house that they do not need to spend time testing LINAK components, as these are already certified. This reduces the customer’s effort and resources involved in certification processes.”
Benefits for customers
Our certified products allow you, as a customer, to focus on your core business without having to deal with the complex aspects of certifying electrical components. This supports product development and the introduction of new solutions to the market. Our customers appreciate this service. For instance, at Cobi Rehab, Tommy J. Fange-Larsen, Product Development & Mechanical Engineer, says:
“The approval process for medical certification of the final product is significantly streamlined when components are tested and approved in advance. For us at Cobi Rehab, this frees up resources so we can focus on optimising mechanical design and other development points. As a company in rehabilitation, we are highly dependent on approved components, as we have a large product catalogue that ends up in healthcare. Therefore, the choice of supplier directly depends on whether their components are pre-approved and tested according to medical standards for electrical equipment.”
This experience is echoed at Ropox, where Oliver W. Udholm has the role of Development Engineer & Responsible for Regulatory.
“If the components were not approved, we would hesitate to use them in our products, as this would create uncertainty about passing laboratory tests for complete products, which also limits the possibility of bidding on tenders, etc,” Oliver explains and elaborates:
“It means a lot to us that LINAK pre-tests the components. When we develop new products or open for redesigns, we consider the electrical components, and we often choose products from LINAK specifically because they are approved – but also because LINAK is an excellent partner as a supplier.”
Future standards
In addition to his role as Regulatory Affairs Manager at LINAK A/S, John Kling contributes to standardisation committees within DS, ISO, and IEC. Through this work, LINAK gains early insight into discussions about upcoming requirements for medical equipment with electrical components, often several years before they are implemented. John’s participation ensures that LINAK stays well informed and aligned with evolving international standards by sharing specialised technical knowledge where relevant and appropriate.
The development of a standard is a thorough process, ranging from proposals and multiple commenting rounds to final voting at the international level. As John Kling explains:
It is important to emphasise that the Medical Device Regulation applies in the EU, which means that all our customers in the EU receive a declaration of conformity. Our thorough and transparent approach to standards and certification ensures that our customers can have full confidence that our components meet the necessary regulatory requirements.
Our commitment to working with standardisation also supports that you, as a customer, are well prepared to meet future requirements and regulations. With LINAK as your partner, you can be assured that your products not only comply with current standards but are also aligned with future requirements. Our focus on quality and safety supports you in delivering reliable solutions to the healthcare sector.
If you would like to know more about our certifications, please feel free to contact us.
