Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-236: IEC 60601-2-45 Edition 3.0 2011-02, Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. (Radiology)
Date of Standard: 2011. |
| 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: |
| ALL OFFICES AND DIVISIONS IN CDRH |
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| Devices Affected: |
| Mammographic X-ray Equipment |
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| Processes Affected: |
| 510(k), PMA, IDE, HDE, MQSA |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
Complete standard
Transition:
FDA recognition of IEC 60601-2-45 Ed. 2.0 (2001) is hereby superseded by recognition of IEC 60601-2-45 Edition 3.0 2011-02 Medical electrical equipment ? Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. FDA will accept declarations of conformity, in support of premarket submissions, to IEC 60601-2-45 Ed. 2.0 (2001) until June 30, 2013. After this transitional period, declarations of conformity to Ed. 2.0 (2001) 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 |
| §892.1710 |
System, X-Ray, Mammographic |
Class 2 |
IZH |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Kish Chakrabarti |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room G308 |
| Silver Spring MD 20993 |
| 301/796-6539 |
| Email: kish.chakrabarti@fda.hhs.gov |
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