IEC 61558-2-15:2022

Overview

IEC 61558-2-15:2022 - third edition - is the international safety standard for isolating transformers for medical IT systems used to supply medical locations. This edition cancels and replaces the 2011 edition and constitutes a technical revision, aligning structure and normative references with IEC 61558-1:2017. It is published as a group safety publication (IEC Guide 104) and provides particular requirements and tests to ensure transformer safety in medical environments.

Key Topics

The standard covers functional and safety requirements, test methods and constructional rules specific to medical isolating transformers. Major technical topics include:

• Protection against electric shock and requirements for medical IT systems
• Insulation resistance, dielectric strength and leakage current measurement (including touch-current networks)
• Creepage distances, clearances and distances through insulation for safer designs in medical locations
• Heating, short‑circuit, overload and inrush current tests to verify thermal performance and protective devices
• Mechanical strength, ingress protection (IP) and resistance to dust/moisture relevant to hospital environments
• Marking, ratings, classification and user information required on equipment and documentation
• Construction, internal wiring, terminals, earthing provisions and components including thermal cut-outs and coated PCBs
• Special tests and methods such as glow-wire, tracking, vibration, routine (production) tests and examples for measurement points

These topics are supported by extensive annexes detailing measurement methods, test sequences and examples to aid conformity assessment.

Applications

IEC 61558-2-15:2022 is intended for designers, manufacturers and test laboratories involved with:

• Medical power supply design - isolating transformers that serve medical IT systems in hospitals, clinics and other medical locations
• Safety and compliance testing for medical transformer products prior to market entry
• Risk mitigation in biomedical engineering and facility power systems by ensuring safe insulation, leakage currents and protective measures
• Procurement and specification teams defining requirements for medical-grade transformers and power equipment

Using this standard helps demonstrate conformance with recognized electrical safety standards and reduce the risk of patient/operational hazards associated with transformer failures.

Who should use this standard

• Transformer and power supply manufacturers (medical grade)
• Safety and compliance engineers, test laboratories and certification bodies
• Biomedical engineers, hospital facilities and procurement specialists
• Regulatory and standards professionals responsible for medical electrical safety

Related standards

• IEC 61558-1:2017 (general requirements referenced and incorporated)
• Normative references cited within the document such as IEC 61032 and IEC 60664-1

Keywords: IEC 61558-2-15:2022, isolating transformers, medical IT systems, medical locations, transformer safety, dielectric strength, leakage current, creepage distances, clearances, electrical safety standard.