Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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031
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Date of Entry 08/06/2013
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FR Recognition Number
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12-205
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Standard | (Included in ASCA) |
IEC 60601-2-5: Edition 3.0 2009-07 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
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Scope/AbstractThis Particular Standard specifies the requirements for safety of ULTRASONIC PHYSIOTHERAPY EQUIPMENT used in medical practice, as defined in 2.1.101.
This Particular Standard does not apply to:
- EQUIPMENT in which a tool is driven by ULTRASOUND (for example EQUIPMENT used in surgery or dentistry);
- EQUIPMENT in which focused ULTRASOUND pulse waves are used to destroy conglomerates such as stones in the kidneys or the bladder (lithotrites) (for information refer to IEC 60601-2-36);
- ULTRASONIC PHYSIOTHERAPY EQUIPMENT in which focused ULTRASOUND pulse waves are used. |
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Public Law, CFR Citation(s) and Procode(s)*
CFR 1050.10 Performance Standards for Sonic, Infrasonic and Ultrasonic Radiation-Emitting Products. Ultrasonic Therapy Products |
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |