Recognition List Number: 024 Publication Date: 06/10/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-211: IEC 60601-2-29 Edition 3.0 2008-06, Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators. (Radiology)
Date of Standard: 2008. |
| 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: |
| Radiation Therapy Simulation Systems |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
Complete Standard and any annexes with specific national alterations for areas not covered by 21 CFR Subchapter J (1000, et. al.).
Transition:
FDA recognition of Second Edition IEC 60601-2-29:1999 is hereby superseded by recognition of IEC 60601-2-29 Edition 3.0 2008-06 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators. FDA will accept declaration of conformity, in support of premarket submissions, to Second Edition IEC 60601-2-29 until June 30, 2013. After this transitional period, declaration of conformity to Second Edition: 1999 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 |
| §892.5840 |
System, Simulation, Radiation Therapy |
Class 2 |
KPQ |
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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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