EN IEC 61558-2-15:2025 PDF
Safety of transformers, reactors, power supply units and combinations thereof - Part 2-15: Particular requirements and tests for isolating transformers for medical IT systems for the supply of medical locations
Safety of transformers, reactors, power supply units and combinations thereof - Part 2-15: Particular requirements and tests for isolating transformers for medical IT systems for the supply of medical locations
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 24
- Дата публикации:
- 14 марта 2025 г.
- Издание:
- CENELEC EN 61558 edition 2 version 1
- ICS:
- 29.180
This part of IEC 61558 deals with safety of isolating transformers for medical IT systems for the supply of medical locations. NOTE 1 Safety includes electrical, thermal and mechanical aspects. Unless otherwise specified, from here onward, the term transformer covers isolating transformers for medical IT systems for the supply of medical locations. This document is applicable to isolating transformers, single-phase or three-phase, air-cooled (natural or forced) dry-type transformers for the supply of medical IT system for group 2 medical locations, designed to be permanently connected to the fixed wiring and intended to form the medical IT system on the secondary side. The windings can be encapsulated or non encapsulated. NOTE 2 IT systems are defined in IEC 60364-1. The installation rules for medical IT system for group 2 medical locations are covered by IEC 60364-7-710. Transformers covered by this document are intended for medical IT systems for the supply of medical locations. All other transformers or equipments connected downstream from 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 operational frequency do not exceed 500 Hz. The rated output does not be less than 0,5 kVA and does not exceed 10 kVA for single-phase and three-phase transformers for medical IT system for group 2 medical locations. This document may be applicable to isolating transformers intended to supply other medical installations that are not group 2 medical locations without limitation of the rated output subject to an agreement between the purchaser and the manufacturer. NOTE 3 Transformers intended to supply distribution networks other than medical IT systems are not included in the scope. The no-load output voltage and the rated output voltage does not exceed 250 V AC for single-phase or three-phase transformer (phase-to-phase voltage). This document does not cover power supply units and is not intended to be used in conjunction with IEC 61558-2-16 for switch mode power supply units. This document is not applicable to external circuits and their components intended to be connected to the input terminals and output terminals of the transformers. Transformers covered by this document are used in applications where double or reinforced insulation between circuits is required by the installation rules or by the appliance specification. NOTE National installation rules of some countries have different or additional requirements listed in Annex C of IEC 60364-7-710:2021. Attention is drawn 193 to the following: - for transformers intended to be used in vehicles, on board ships, and aircraft, additional requirements (from other applicable standards, national rules, etc.); - measures to protect the enclosure and the components inside the enclosure against external influences such as fungus, vermin, termites, solar-radiation, and icing; - the different conditions for transportation, storage, and operation of the transformers; - additional requirements in accordance with other appropriate standards and national rules may be applicable to transformers intended for use in special environments. This GROUP SAFETY PUBLICATION focusing on SAFETY guidance is primarily intended to be used as a PRODUCT SAFETY STANDARD for the products mentioned in the scope, but is also intended to be used by TCs in the preparation of publications for products similar to those mentioned in the scope of this GROUP SAFETY PUBLICATION, in accordance with the principles laid down in IEC Guide 104 and lSO/lEC Guide 51. One of the RESPONSIBILITIES of a TC is, wherever applicable, to make use of BSPs and/or GSPs in the preparation of its publications.
Abstract
Overview
EN IEC 61558-2-15:2025 (CLC adoption of IEC 61558-2-15) is the product safety standard that specifies particular requirements and tests for isolating transformers used to form medical IT systems supplying medical locations. It focuses on electrical, thermal and mechanical safety for dry-type, air-cooled isolating transformers (single- or three-phase) permanently connected to fixed wiring and intended to form the secondary side of a medical IT system for group 2 medical locations (see IEC 60364-7-710 for definitions and installation rules).
Key topics and technical requirements
This standard supplements IEC 61558-1 and addresses transformer-specific safety and test requirements, including:
- Scope and ratings: rated supply voltage ≤ 1 000 V AC, frequency ≤ 500 Hz, rated outputs 0.5 kVA to 10 kVA (single- and three-phase); no-load/rated output ≤ 250 V AC (phase-to-phase).
- Construction and insulation: requirements for double or reinforced insulation between circuits; windings may be encapsulated or non-encapsulated.
- Protection against electric shock: earthing provisions, leakage current limits and measurement circuits.
- Dielectric and insulation tests: insulation resistance, dielectric strength (additional test voltages), and leakage current verification.
- Thermal and heating tests: temperature rise and thermal protection under normal and overload conditions.
- Short-circuit and overload protection: requirements for protective devices and short-circuit withstand.
- Mechanical and environmental tests: mechanical strength, ingress protection, resistance to rusting, and special environmental considerations (transport, storage, fungus, vermin, etc.).
- Marking, ratings and documentation: required labels, symbols (see Table 101), and user/manufacturer information.
- Excluded items: not applicable to downstream equipment, power supply units (including SMPS - see IEC 61558-2-16), or transformers for general distribution networks unless agreed between purchaser and manufacturer.
Practical applications
- Designing, manufacturing and testing isolating transformers for medical IT systems used to supply medical premises that require enhanced safety and controlled leakage currents.
- Selection and procurement of transformers for hospitals and medical facilities where compliance with electrical safety and installation rules (IEC 60364 series) is required.
- Type-testing and routine production testing in laboratories to demonstrate conformity with medical transformer safety requirements.
Who should use this standard
- Transformer manufacturers and design engineers
- Medical electrical infrastructure designers and hospital facility engineers
- Test labs, conformity assessors and certification bodies
- Procurement, compliance and safety officers in healthcare and medical device sectors
- Technical committees and standards developers
Related standards
- IEC 61558-1 (general requirements and tests)
- IEC 60364-7-710 (installation rules for medical locations)
- IEC 61557-8 (protective measures for IT systems)
- IEC 61558-2-16 (note: SMPS-specific requirements; this document is not intended for SMPS)
Keywords: EN IEC 61558-2-15:2025, isolating transformers, medical IT systems, transformer safety, leakage current, dielectric strength, dry-type transformers, medical locations.
Технические детали
- Технический комитет
- CLC/SR 96 - Small power transformers, reactors, power supply units and similar products
- SKU
- EN IEC 61558-2-15:2025
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