As adjustable electric systems play a more significant role in healthcare today, to ensure the safety of patients and clinicians strictly defined standards and norms must be met. To help customers gain the necessary approvals for modern healthcare equipment, LINAK spends significant resources to meet these standards.
“Demonstrating safety is a big task when bringing medical equipment to market. By designing with LINAKs certified components, our medical customers see a faster and more direct path to approval - and to market,” says Andrew McGinnis, R&D Project Manager.
Safety: Designed In
For more than 20 years, LINAKs products have met standards and norms set forth by the healthcare industry. You can rest assured that working with LINAK makes it easier to comply with standards and gain approvals. From mechanical safety features, such as a safety nut, quick release, or ratchet spline function, to OpenBus™ solutions preventing unintended movement or providing performance status data – LINAK has a product to meet your needs.
“The more aspects that are considered under the topic of safety, the safer our products become for both the users and for the patient,” says Jørgen Sobol, LINAK Sales Director. “For us this is an everlasting journey.”
Quick release is an important functionality that ensures fast lowering of the application in emergency situations, e.g., if CPR is needed.To align with IEC 62366 requirements, LINAK has a well-defined risk management process including engineering processes focued on usability. We relate to product misuse or situations that can cause risks when the product is in use and we make recommendations and warnings to reduce the risk.
“Risk Management is more than paperwork; it actually helps LINAK make safer, more reliable products. The knowledge built by our Risk Management process guides every step of our product design, testing, and production” says McGinnis.
Additionally, LINAK is certified in accordance with the ISO14971 Risk Management standard and provides residual risk documentation for all components to help you in the risk analysis process.
Many healthcare applications must be able to withstand water and detergents when washed. LINAK® products for healthcare are at least IPX4 rated; however, when required, our systems can rate as high as IPX6 Washable DURA™.
