| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
050
|
Date of Entry 09/17/2018
|
|
FR Recognition Number
|
12-319
|
| Standard | (Included in ASCA) |
IEC 60601-2-68 Edition 1.0 2014-09
Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
|
Scope/Abstract| This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE). This particular standard covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging devices in a known geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EXTERNAL BEAM EQUIPMENT and X-ray imaging devices, attached or not directly attached to, but in the same RADIATION shielded area as, and dedicated for use only with, the EXTERNAL BEAM EQUIPMENT. This particular standard deals with equipment for REAL-TIME X-IGRT, ONLINE X-IGRT and OFFLINE X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EXTERNAL BEAM SYSTEM (X-IGRT EBS). For example the manufacturer will provide an interactive interface for user interaction with the correction suggested by the system. |
|
| 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. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §892.5050 |
Accelerator, Linear, Medical
|
Class 2
|
IYE
|
| §892.5050 |
System, Radiation Therapy, Charged-Particle, Medical
|
Class 2
|
LHN
|
| §892.5750 |
System, Radiation Therapy, Radionuclide
|
Class 2
|
IWB
|
|
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 Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
