This standard specifies the characteristics of electrically generated signals intended for use with medical devices individually or as part of a central system. This standard is only valid if a particular device standard refers to it. The requirements for the implementation of signals specified in this standard are expected to be contained in certain standards for certain medical devices.
This standard does not specify:
Those who write a specific standard for a particular medical device must determine whether that device requires an alarm and, if so, which alarms should be provided. In some cases, their provision may be optional. The purpose of this standard is to specify the signals to be used when a particular standard indicates that an alarm will be provided.
The assignment of an alarm belonging to the category of urgency is at the discretion of the manufacturer or operator of the device. All or indeed any of the signals specified in this standard need not be incorporated into any medical device.
EUROLAB assists manufacturers with EN 475 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
