IEC 60601-2-37:2007
Collections
International IEC standards
Publication date
August 2007
Number of pages
82 p.
Reference
IEC 60601-2-37:2007
IEC 60601-2-37:2007
August 2007
International standard
Cancelled
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Applies to the basic safety and essential performance of ultrasonic diagnostic equipment. The approach and philosophy used in drafting this particular standard for safety of ultrasonic diagnostic equipment are consistent with those in standards of the IEC 60601 2 xx series that apply to other diagnostic modalities, such as X-ray equipment and magnetic resonance systems. In each case, the safety standard is intended to require increasing sophistication of output display indicators and/or controls with increasing energy levels in the interrogating field of diagnosis. Thus, for all such diagnostic modalities, it is the responsibility of the operator to understand the risk of the output of the ultrasonic diagnostic equipment, and to act appropriately in order to obtain the needed diagnostic information with the minimum risk to the patient. This second edition cancels and replaces the first edition published in 2001 and its Amendment 1 (2004) and Amendment 2 (2005). This edition combines the previous edition and its amendments into a form compatible with the parent IEC 60601-1:2005.
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Sumary
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Applies to the basic safety and essential performance of ultrasonic diagnostic equipment. The approach and philosophy used in drafting this particular standard for safety of ultrasonic diagnostic equipment are consistent with those in standards of the IEC 60601 2 xx series that apply to other diagnostic modalities, such as X-ray equipment and magnetic resonance systems. In each case, the safety standard is intended to require increasing sophistication of output display indicators and/or controls with increasing energy levels in the interrogating field of diagnosis. Thus, for all such diagnostic modalities, it is the responsibility of the operator to understand the risk of the output of the ultrasonic diagnostic equipment, and to act appropriately in order to obtain the needed diagnostic information with the minimum risk to the patient. This second edition cancels and replaces the first edition published in 2001 and its Amendment 1 (2004) and Amendment 2 (2005). This edition combines the previous edition and its amendments into a form compatible with the parent IEC 60601-1:2005.
Applies to the basic safety and essential performance of ultrasonic diagnostic equipment. The approach and philosophy used in drafting this particular standard for safety of ultrasonic diagnostic equipment are consistent with those in standards of the IEC 60601 2 xx series that apply to other diagnostic modalities, such as X-ray equipment and magnetic resonance systems. In each case, the safety standard is intended to require increasing sophistication of output display indicators and/or controls with increasing energy levels in the interrogating field of diagnosis. Thus, for all such diagnostic modalities, it is the responsibility of the operator to understand the risk of the output of the ultrasonic diagnostic equipment, and to act appropriately in order to obtain the needed diagnostic information with the minimum risk to the patient. This second edition cancels and replaces the first edition published in 2001 and its Amendment 1 (2004) and Amendment 2 (2005). This edition combines the previous edition and its amendments into a form compatible with the parent IEC 60601-1:2005.
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Replaced standards
(3)
IEC 60601-2-37:2001/AMD1:2004
August 2004
International standard
Cancelled
Amendment 1 - Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
IEC 60601-2-37:2001
July 2001
International standard
Cancelled
Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
Establishes particular requirements for the safety of ultrasonic diagnostic equipment and those aspects thereof which are directly related to safety. Does not cover ultrasonic therapeutic equipment; however, equipment used for the imaging of body structures by ultrasound in conjunction with therapeutic modalities is covered.
IEC 60601-2-37:2001/AMD2:2005
November 2005
International standard
Cancelled
Amendment 2 - Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
Standard replaced by
(1)
IEC 60601-2-37:2024
July 2024
International standard
Current
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 60601-2-37:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.7.2.13. This document does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered. IEC 60601-2-37:2024 cancels and replaces the second edition published in 2007 and Amendment 1:2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) technical and editorial changes resulting from the amended general standard IEC 60601 1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and its collateral standards IEC 60601-1-xx, b) technical and editorial changes as a result of maintenance to normative references; c) technical and editorial changes resulting from relevant developments in TC 87 Ultrasonics standards. In particular, Clause 201.11 about protection against excessive temperatures and other hazards has been fully revised.
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