IEC EN 61558-2-15 Procurement of Medical Locations - Testing for Medical IT Systems

Medical Device Tests

IEC EN 61558-2-15 Procurement of Medical Locations - Testing for Medical IT Systems

EUROLAB, together with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of IEC EN 61558-2-15 testing. This standard deals with the safety aspects of the isolation of transformers for the supply of medical locations.

IEC EN 61558-2-15 Procurement of Medical Locations - Testing for Medical IT Systems

Safety includes electrical, thermal and mechanical aspects. Unless otherwise specified, the term transformer hereinafter includes isolation transformers for medical IT systems for the supply of medical locations.

This document is applicable to single-phase or three-phase, air-cooled (natural or forced) dry-type transformers for supplying the medical IT system for group 2 medical locations, designed to be permanently connected to fixed wiring. and on the secondary side, it aimed to create a medical information system.

Windings can be encapsulated or unencapsulated. IT systems are defined in IEC 60364-1. Medical IT system installation rules for group 2 medical locations are covered by IEC 60364-7-710. Transformers covered in this document are intended for medical IT systems for the supply of medical locations. All other transformers or equipment connected downstream of the transformer are not covered by this document.

The rated supply voltage does not exceed 1 000 V AC. The rated supply frequency and internal operating frequency do not exceed 500 Hz. For group 2 medical locations, the rated output is not less than 0,5 kVA and not exceeding 10 kVA for single-phase and three-phase transformers for medical IT system.

This document is applicable to isolation transformers intended to supply other medical installations other than group 2 medical locations without limitation of rated output, subject to an agreement between the purchaser and the manufacturer.

Transformers intended to feed distribution networks other than medical IT systems are not covered. The no-load output voltage and the rated output voltage do not exceed 250 V AC for a single-phase or three-phase transformer (phase-to-phase voltage). This document does not cover power supply units and is not intended for use with IEC 61558-2-16 for switched mode power supply units.

This document does not apply to external circuits and their components intended to be connected to the input terminals and output terminals of transformers. Transformers within the scope of this document are used in applications where double or reinforced insulation between circuits is required by installation rules or device specification.

EUROLAB assists manufacturers with IEC EN 61558-2-15 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.

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