| 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 |
Cyclotron, Medical
|
Class 2
|
IWK
|
| §892.5050 |
Synchrotron, Medical
|
Class 2
|
IWM
|
| §892.5050 |
Accelerator, Linear, Medical
|
Class 2
|
IYE
|
| §892.5050 |
Betatron, Medical
|
Class 2
|
IYG
|
| §892.5050 |
Microtron, Medical
|
Class 2
|
JAE
|
| §892.5050 |
System, Radiation Therapy, Charged-Particle, Medical
|
Class 2
|
LHN
|
| §892.5050 |
System, Planning, Radiation Therapy Treatment
|
Class 2
|
MUJ
|
| §892.5050 |
Accessory - Film Dosimetry System
|
Class 2
|
MWW
|
| §892.5050 |
Dosimeter, Ionizing Radiation, Implanted
|
Class 2
|
NZT
|
| §892.5750 |
System, Radiation Therapy, Radionuclide
|
Class 2
|
IWB
|
| §892.5750 |
Device, Beam Limiting, Teletherapy, Radionuclide
|
Class 2
|
IWD
|
| §892.5900 |
Generator, Orthovoltage, Therapeutic X-Ray
|
Class 2
|
IYC
|
| §892.5900 |
Generator, Low Voltage, Therapeutic X-Ray
|
Class 2
|
IYD
|
| §892.5900 |
Generator, Dermatological (Grenz Ray), Therapeutic X-Ray
|
Class 2
|
IYH
|
| §892.5900 |
Collimator, Orthovoltage, Therapeutic X-Ray
|
Class 2
|
IYI
|
| §892.5900 |
Collimator, Low Voltage, Therapeutic X-Ray
|
Class 2
|
IYJ
|
| §892.5900 |
Collimator, High Voltage, Therapeutic X-Ray
|
Class 2
|
IYK
|
| §892.5900 |
Collimator, Dermatological, Therapeutic X-Ray
|
Class 2
|
IYL
|
| §892.5900 |
System, Therapeutic, X-Ray
|
Class 2
|
JAD
|
| §892.5900 |
Generator, High Voltage, X-Ray, Therapeutic
|
Class 2
|
KPZ
|
| §892.5900 |
Device, Beam Limiting, X-Ray, Therapeutic
|
Class 2
|
KQA
|
|
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. |
|
|
