Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
026
|
Date of Entry 03/14/2011
|
FR Recognition Number
|
12-217
|
Standard | |
IEC 62083 Edition 2.0 2009-09 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
|
Scope/AbstractThis International Standard applies to the design, manufacture and some installation aspects of a radiotherapy treatment planning systems(RTPS)
- for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice;
- that imports data either through input by the OPERATOR or directly from other devices;
- that outputs data either in printed form for review or directly to other devices;
- and which is intended to be
- for NORMAL USE, under the authority of appropriately licensed or QUALIFIED PERSONS, by OPERATORS having the required skills and training;
- maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and
- used within the environmental and electrical supply conditions SPECIFIED in the technical description. |
|
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 |
Accessory - Film Dosimetry System |
Class 2 |
MWW |
§892.5050 |
Betatron, Medical |
Class 2 |
IYG |
§892.5050 |
Cyclotron, Medical |
Class 2 |
IWK |
§892.5050 |
Dosimeter, Ionizing Radiation, Implanted |
Class 2 |
NZT |
§892.5050 |
Microtron, Medical |
Class 2 |
JAE |
§892.5050 |
Synchrotron, Medical |
Class 2 |
IWM |
§892.5050 |
System, Planning, Radiation Therapy Treatment |
Class 2 |
MUJ |
§892.5050 |
System, Radiation Therapy, Charged-Particle, Medical |
Class 2 |
LHN |
§892.5900 |
Collimator, Dermatological, Therapeutic X-Ray |
Class 2 |
IYL |
§892.5900 |
Collimator, High Voltage, Therapeutic X-Ray |
Class 2 |
IYK |
§892.5900 |
Collimator, Low Voltage, Therapeutic X-Ray |
Class 2 |
IYJ |
§892.5900 |
Collimator, Orthovoltage, Therapeutic X-Ray |
Class 2 |
IYI |
§892.5900 |
Device, Beam Limiting, X-Ray, Therapeutic |
Class 2 |
KQA |
§892.5900 |
Generator, Dermatological (Grenz Ray), Therapeutic X-Ray |
Class 2 |
IYH |
§892.5900 |
Generator, High Voltage, X-Ray, Therapeutic |
Class 2 |
KPZ |
§892.5900 |
Generator, Low Voltage, Therapeutic X-Ray |
Class 2 |
IYD |
§892.5900 |
Generator, Orthovoltage, Therapeutic X-Ray |
Class 2 |
IYC |
§892.5900 |
System, Therapeutic, X-Ray |
Class 2 |
JAD |
§892.5750 |
Device, Beam Limiting, Teletherapy, Radionuclide |
Class 2 |
IWD |
§892.5750 |
System, Radiation Therapy, Radionuclide |
Class 2 |
IWB |
|
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. |
|
FDA Technical Contact
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
|
|
*These are provided as examples and others may be applicable. |
|
|