IEC 60601-2-37:2024

Overview

IEC 60601-2-37:2024 is the third edition (Edition 3.0, 2024) of the particular standard for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. It applies to ultrasonic diagnostic ME EQUIPMENT and ME SYSTEMS (as defined in the standard) and supersedes IEC 60601-2-37:2007 and Amendment 1:2015. The document focuses on safety and performance requirements for diagnostic imaging and monitoring by ultrasound, explicitly excluding ultrasonic therapeutic equipment. It also covers equipment used for imaging in conjunction with other medical procedures.

Key topics and requirements

• Scope and applicability - clarifies when clauses apply to ME EQUIPMENT, ME SYSTEMS, or both; excludes physiological-function hazards except where noted.
• Basic safety & essential performance - requirements supplementing the general IEC 60601-1 series to address ultrasonic-specific risks.
• Protection against hazards - measures for electrical, mechanical, thermal and radiation hazards (notably Clause 201.11 on protection against excessive temperatures and other hazards has been fully revised).
• Acoustic output and reporting - requirements and an acoustic output reporting table for consistent third‑party reporting and communication of ultrasound exposure indices.
• Testing and measurement - test methods for surface temperature of transducers, acoustic and thermal properties, and distributed essential performance tests.
• Electromagnetic compatibility (EMC) - EMC requirements and disturbance tests for safe operation in clinical environments.
• Programmable systems (PEMS) - guidance and requirements for programmable electrical medical systems used in diagnostic ultrasound.
• Identification, marking and documentation - operator information (TI/MI), labeling, and technical documentation requirements to support safe clinical use.
• Annexes with guidance - informative annexes (AA, BB, CC, DD, EE) providing rationale, CISPR 11 classification guidance, operator information interpretation, test setups, and example output tables.

Applications and who uses this standard

• Manufacturers of diagnostic ultrasound systems and transducer assemblies - for design, risk management, and conformity.
• Test laboratories and certification bodies - to develop test procedures and assess compliance.
• Regulatory authorities and notified bodies - to evaluate safety/performance claims during market approval.
• Clinical engineers and procurement teams - to interpret device labeling, acoustic output, and safe‑use guidance.
• R&D and quality teams - to align product development with updated IEC 60601-1 amendments and TC 87 Ultrasonics developments.

Related standards

• IEC 60601-1 (general medical electrical safety) and its amendments (AMD1:2012, AMD2:2020)
• Collateral IEC 60601-1-xx standards and relevant TC 87 Ultrasonics documents

Keywords: IEC 60601-2-37:2024, ultrasonic medical diagnostic equipment, medical electrical equipment, acoustic output, transducer temperature, EMC, PEMS, basic safety, essential performance.