BS EN IEC 61558-2-15:2025

Safety of Transformers, Reactors, Power Supply Units and Combinations Thereof

Particular Requirements and Tests for Isolating Transformers for Medical IT Systems for the Supply of Medical Locations

Introducing the BS EN IEC 61558-2-15:2025, a comprehensive standard that sets the benchmark for safety in the design and testing of isolating transformers specifically tailored for medical IT systems. This standard is essential for ensuring the reliable and safe operation of transformers used in critical medical environments, where precision and safety are paramount.

Key Features:

• Standard Number: BS EN IEC 61558-2-15:2025
• Pages: 26
• Release Date: March 19, 2025
• ISBN: 978 0 539 17157 0
• Status: Standard

This standard is a critical resource for manufacturers, engineers, and safety professionals involved in the design, production, and maintenance of medical IT systems. It provides detailed requirements and testing procedures to ensure that isolating transformers meet the highest safety standards, thereby safeguarding both patients and medical personnel.

Why Choose BS EN IEC 61558-2-15:2025?

The BS EN IEC 61558-2-15:2025 standard is meticulously crafted to address the unique challenges faced in medical environments. It ensures that transformers used in these settings are capable of handling the specific demands of medical IT systems, which are often subject to stringent regulatory requirements.

By adhering to this standard, manufacturers can demonstrate their commitment to safety and quality, providing peace of mind to healthcare providers and patients alike. The standard outlines rigorous testing protocols that transformers must undergo to ensure they can operate safely under various conditions, including potential electrical faults and environmental stresses.

Comprehensive Coverage:

The standard covers a wide range of topics, including:

• Design specifications for isolating transformers used in medical IT systems.
• Testing procedures to verify compliance with safety requirements.
• Guidelines for installation and maintenance to ensure ongoing safety and performance.
• Requirements for materials and construction to withstand the demands of medical environments.

Benefits of Compliance:

Compliance with the BS EN IEC 61558-2-15:2025 standard offers numerous benefits, including:

• Enhanced Safety: Ensures that transformers are designed and tested to prevent electrical hazards, protecting both patients and medical staff.
• Regulatory Compliance: Helps manufacturers meet regulatory requirements, facilitating market access and reducing the risk of non-compliance penalties.
• Quality Assurance: Demonstrates a commitment to quality and safety, enhancing the reputation of manufacturers and instilling confidence in healthcare providers.
• Operational Reliability: Ensures that transformers can operate reliably under the demanding conditions of medical environments, minimizing downtime and maintenance costs.

Who Should Use This Standard?

The BS EN IEC 61558-2-15:2025 standard is an invaluable resource for a wide range of professionals, including:

• Manufacturers of transformers and power supply units for medical IT systems.
• Electrical engineers and designers involved in the development of medical equipment.
• Quality assurance and compliance officers in the medical device industry.
• Healthcare facility managers responsible for the safety and reliability of medical equipment.

Conclusion:

The BS EN IEC 61558-2-15:2025 standard is a vital tool for ensuring the safety and reliability of isolating transformers used in medical IT systems. By providing clear guidelines and rigorous testing procedures, it helps manufacturers produce high-quality transformers that meet the demanding requirements of medical environments. Adopting this standard not only enhances safety but also supports regulatory compliance and operational efficiency, making it an essential resource for anyone involved in the medical device industry.

BS EN IEC 61558-2-15:2025

This standard BS EN IEC 61558-2-15:2025 Safety of transformers, reactors, power supply units and combinations thereof is classified in these ICS categories:

• 29.180 Transformers. Reactors

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.