Recognition List Number: 024 Publication Date: 06/10/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-207: IEC 60601-2-33 Edition 3.0 2010-03, Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic. (Radiology)
Date of Standard: 2010. |
| 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: |
| Magnetic Resonance Imaging Systems, Magnetic Resonance Spectroscopic Systems, Magnetic Resonance Specialty Coils |
|
| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE |
|
| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
Complete standard and any annexes with specific national alterations, except section 51.101.2.
Transition:
FDA recognition of Consolidated Edition 2.2:2008 of IEC 60601-2-33 is hereby superseded by recognition of IEC 60601-2-33 Edition 3.0 2010-03 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis. FDA will accept declarations of conformity, in support of premarket submissions, to IEC 60601-2-33:2008 until June 20, 2013. After this transition period, declarations of conformity to Consolidated Edition 2.2:2008 of the standard will not be accepted. |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1000 |
Coil, Magnetic Resonance, Specialty |
Class 2 |
MOS |
| §892.1000 |
Magnetic Resonance Imaging Disposable Kit |
Class 2 |
OIM |
| §892.1000 |
System, Nuclear Magnetic Resonance Imaging |
Class 2 |
LNH |
| §892.1000 |
System, Nuclear Magnetic Resonance Spectroscopic |
Class 2 |
LNI |
| |
|
| Relevant Guidance: |
Guidance for Industry
Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices. Document issued on: November 14, 1998
Guidance for Industry and FDA Staff Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices. Document issued on: July 14, 2003 |
|
| FDA Technical Contact: |
| Wolfgang Kainz |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 1132 |
| Silver Spring MD 20993 |
| 301/796-2484 |
| Email: wolfgang.kainz@fda.hhs.gov |
|
|
