Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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050
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Date of Entry 09/17/2018
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FR Recognition Number
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9-119
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Standard | (Included in ASCA) |
IEC 60601-2-36 Edition 2.0 2014-04 Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy |
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Scope/AbstractThis particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment for EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 201.3.206 including equipment for other medical applications of therapeutic extracorporeally induced focused PRESSURE PULSES,hereafter referred to as ME EQUIPMENT. The applicability of this particular standard is limited to components directly involved in the LITHOTRIPSY treatment, such as, but not limited to, the generator of the PRESSURE PULSE, PATIENT support device, and their interactions with imaging and monitoring devices. Other devices, such as PATIENT treatment planning computers, X-ray and ultrasonic devices, are excluded from this standard, because they are treated in other applicable IEC standards. |
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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)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§876.5990 |
Lithotriptor, Extracorporeal Shock-Wave, Urological
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Class 2
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LNS
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Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
2. Guidance for Industry and for FDA Reviewers-Guidance for the Content of Premarket Notification [510(k)s] for Extracoporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi, Issued August 2000.
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)
ObGyn/Gastroenterology/Urology |
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*These are provided as examples and others may be applicable. |