Recognition List Number: 024 Publication Date: 06/10/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-209: IEC 60601-2-37 Edition 2.0 2007-08, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. (Radiology)
Date of Standard: 2007. |
| 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 IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) | | |
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| Devices Affected: |
| Establishes particular requirements for the safety of ultrasonic equipment and those aspects there of which are directly related to safety. Does not cover ultrasonic therapeutic equipment; however, equipment used for the imaging of body structures by ultrasound in conjunction with therapeutic modalities is covered. |
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| Processes Affected: |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
Complete standard and any annexes.
Transition:
FDA recognition of IEC 60601-2-37:2004 & 2005 is hereby superseded by recognition of IEC 60601-2-37 Edition 2.0 2007-08 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. FDA will accept declarations of conformity, in support of premarket submissions, to IEC 60601-2-37:2004 & 2005 until June 30 2013. After this transition period, declarations of conformity to IEC 60601-2-37:2004 & 2005 of the standard will not be accepted. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1570 |
Transducer, Ultrasonic, Diagnostic |
Class 2 |
ITX |
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| Relevant Guidance: |
| Guidance for Industry and FDA Staff Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Documents issued on: September 9, 2008 |
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| FDA Technical Contact: |
| Bruce Herman |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 2214 |
| Silver Spring MD 20903 |
| 301/796-2521 |
| Email: bruce.herman@fda.hhs.gov |
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