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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Entry 07/09/2014 
FR Recognition Number 12-281
Standard(Included in ASCA)
IEC  60601-2-62 Edition 1.0 2013-07
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
IEC 60601-2-62:2013 applies to the basic safety and essential performance of HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT. This International Standard adds or replaces clauses listed in the IEC 60601-1 that are specific for HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT. If a clause or subclause is specifically intended to be applicable to such equipment only, or to related 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 individual equipment and to systems, as relevant. Hazards inherent in the intended physiological function of the equipment or systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. This standard can also be applied to
- therapeutic equipment for thrombolysis through exposure to high-intensity therapeutic ultrasound;
- therapeutic equipment for the treatment of occluding feeding vessels through exposure to high-intensity focused ultrasound;
- and equipment intended to be used for relieving cancer pain due to bone metastases.
This particular standard does not apply to
- Ultrasound Equipment intended to be used for physiotherapy (use IEC 60601-2-5 and IEC 61689);
- Ultrasound Equipment intended to be used for lithotripsy (use IEC 60601-2-36);
- Ultrasound Equipment intended to be used for dedicated hyperthermia devices; and
- Ultrasound Equipment intended to be used for phacoemulsification.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§878.4400 System, Ablation, Ultrasound And Accessories Class 2 NTB
§878.4590 Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption Class 2 OHV
N/A Applicator, Hyperthermia, Deep Heating, Ultrasound Class 3 LNB
N/A Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided Class 3 NRZ
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Keith Wear
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.