When working in the healthcare business safety is an omnipresent topic. Not only patients need to feel safe – healthcare professionals must also have a safe working environment to stay efficient and provide the optimal treatment and care. Even the adjustable applications used need to be safe, i.e. they must be extremely durable to be able to perform safely through a long service life. LINAK includes all concerns when developing actuator systems for modern healthcare equipment, and here is why.
Comply with set standards to get medical approval
Multiple strictly defined standards and norms need to be followed in order to get the approvals needed to provide healthcare equipment today. As adjustable systems play a central role in today’s healthcare, LINAK spends significant resources to meet these standards.
‘Anyone bringing a product onto the market today without paying close attention to safety will probably fail’, says Jørgen Sobol, LINAK Sales Director. ‘As a supplier of electrical components for healthcare, LINAK has a special duty here’.
LINAK products have been living up to standards and norms for many years. This has made it easier for manufacturers of healthcare equipment to comply with standards and get the approvals they need.
To be aligned with the requirements in IEC 62366, LINAK has a well-defined Risk Management process including usability engineering processes.
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.
LINAK is certified in accordance with the ISO14971 Risk Management standard. We provide residual risk documentation for all our components to help the application manufacturer in the risk analysis process.
Safety inside out in all products
From the mechanical safety features, such as a safety nut, quick release, or a ratchet spline function, to OpenBus™ solutions providing performance status data or preventing unintended movement – LINAK has it covered.
We even help, for example, hospitals fight bacteria by making more of our products easy to clean in an effective way. The LINAK standard of IPX6 Washable DURA™ is an example of this. We continuously seek ways to improve the current status quo, and in some respects, we help push standards even further, for you to have a market advantage.
‘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. ‘For us this is an everlasting journey’.
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™.