| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
050
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Date of Entry 09/17/2018
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|
FR Recognition Number
|
12-320
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| Standard | |
IEC 62667 Edition 1.0 2017-08
Medical electrical equipment - Medical light ion beam equipment - Performance characteristics |
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Scope/AbstractThis document applies to LIGHT ION BEAM ME EQUIPMENT when used, for therapy purposes, in human medical practice. This document applies to LIGHT ION BEAM ME EQUIPMENT which delivers LIGHT ION BEAMS with an ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n. This document describes measurements and test procedures to be performed by the MANUFACTURER of LIGHT ION BEAM ME EQUIPMENT but does not specify ACCEPTANCE TESTS.
This document specifies test procedures for the determination and disclosure of performance characteristics, knowledge of which is necessary for proper selection, application, and use of LIGHT ION BEAM ME EQUIPMENT and which are to be declared in the ACCOMPANYING DOCUMENTATION together with the greatest deviation or variation to be expected under specific conditions in NORMAL USE. A format for presentation of performance values is given in Annex A. |
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| Extent of Recognition
|
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 |
| §892.5050 |
System, Radiation Therapy, Charged-Particle, Medical
|
Class 2
|
LHN
|
|
Relevant FDA Guidance and/or Supportive Publications*
| 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 Contacts
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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. |
