Recognition List Number: 024 Publication Date: 06/10/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-206: IEC 60601-2-1 Edition 3.0 2009-10, Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV. (Radiology)
Date of Standard: 2009. |
| Address of Standards Organization: |
| International Electrotechnical Commission (IEC) |
| 3, Rue de Varembe' |
| PO Box 131 |
| CH-1211 Geneva 20, 0 |
|
SWITZERLAND
|
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) | | |
|
|
| Devices Affected: |
|
| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input |
|
| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
Complete standard and any annexes with specific national alterations.
Transitions:
FDA recognition of Amendment 1:2002 of IEC 60601-2-1 is hereby superseded by recognition of IEC 60601-2-1 Edition 3.0 2009-10 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV. FDA will accept declarations of conformity, in support of premarket submissions, to IEC 60601-2-1 (1998) Amendment 1:2002 until June 30, 2013. After this transition period, declarations of conformity to Amendment 1:2002 of the standard will not be accepted. |
|
| 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 |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| 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 |
|
|
|
| * 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 |
|
|
