The collateral standard DIN EN 60601-1-6

Ergonomic aspects of medical products more and more become the focus of attention in the development process, which is verified by the collateral standard DIN EN 60601-1-6 and 62366.

DIN EN 60601-1-6

The standard DIN EN 60601-1-6 refers to the safety of electrical medical devices, such as dialysis machines or heart-lung machines. Therefore, it concerns all manufacturers who want to place a device on the market defined as such by the medical products directive 93/42/EEC.

The ending "-6" describes the amendment of the standard DIN EN 60601-1. The standard DIN EN 60601-1-6 defines the execution of the usability engineering process. A usability file for documentation purposes is also compulsory. Based on this document, the notifed bodies verify, whether a product has been developed in compliance with the standards and whether it meets the requirements of usability and safety.

Extension by standard DIN EN 62366

In March 2010, the transitional period of the standard DIN EN 62366 ended. Since that time, manufacturers of medical devices and in-vitro diagnostics must comply with the standard. The standards DIN EN 62366 and DIN EN 60601-1-6 While the collateral standard DIN EN 60601-1-6 refers to manufacturers of electrical medical devices, the DIN EN 62366 expands the scope of relevant products to all medical devices such as implants or medical software.