Recognition List Number: 017 Publication Date: 05/21/2007
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-152: IEC 60601-2-1 (1998) Amendment 1: 2002, Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV. (Radiology)
Date of Standard: 1998. |
| Address of Standards Organization: |
| International Electrotechnical Commission (IEC) |
| 3, Rue de Varembe' |
| PO Box 131 |
| CH-1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
| Complete standard and any annexes with specific national alterations |
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| Related CFR Citations and Product Codes: |
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, Radiation Therapy, Charged-Particle, Medical |
Class 2 |
LHN |
| §892.5050 |
System,Planning,Radiation Therapy Treatment |
Class 2 |
MUJ |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| John Chen |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room G302 |
| Silver Spring MD 20993 |
| 301/796-6540 |
| Email: john.chen@fda.hhs.gov |
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| * In the United States, copies of this standard can be obtained from: |
| American National Standards Institute (ANSI)* |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
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