EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of IEC EN 60601-2-27 testing. This standard also applies to ECG telemetry systems used in the hospital environment.
This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-2-27 Electrical medical equipment - Part 2-27: Specific features for the basic safety and required performance of electrocardiography monitoring equipment.
This standard describes the criteria for electrocardiographic monitoring devices intended for use in uncontrolled and difficult environmental conditions, such as ambulances and air transport outside the hospital environment. In addition, if there are other standards for these usage environments, these criteria also apply. However, this standard does not apply to electrocardiographic monitoring devices designed for home use. Nevertheless, manufacturers should consider the relevant criteria of this standard in their production programs in accordance with their intended use.
Outpatient monitoring (holter), fetal heart rate monitoring, organ growth monitoring and other ECG recording devices are not covered by this standard.
The following standards referenced during the implementation of the IEC 60601-2-27 standard are indispensable: IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-8 (general requirements, tests and guidance for medical electrical equipment and alarm systems in medical electrical systems ), IEC 60601-2-2 (special requirements for basic safety and basic performance of high-frequency surgical equipment and high-frequency surgical accessories), IEC 60601-2-25 (special rules for basic safety and basic performance of electrocardiographs), and IEC 60601-2 -49 (special requirements for basic safety and basic performance of multifunctional patient monitoring equipment)
EUROLAB assists manufacturers with IEC EN 60601-2-27 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.
