| IEC 60601-2-17 Edition 3.0 2013-11 Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment |
| Recognition Date | 2014-07-09 |
| Recognition List | 036 |
| Recognition Number | 12-272 |
| Extent | Complete standard |
| Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
| STG | Radiology |
| FDA Tech | John Chen FDA/OMPT/CDRH/OIR/DRH/NMRT/ 301-796-6540 john.chen@fda.hhs.gov |
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IEC 60601-2-17:2013 applies to the basic safety and essential performance of automatically-controlled Brachytherapy Afterloading Medical Equipment. This standard does not specify requirements for sealed radioactive sources. This third edition cancels and replaces the second edition, published in 2004. Consideration has been given to new IEC standards, amendments to existing IEC standards, developments in technology and clinical usage, and various hazards encountered and envisaged since the preparation of the first and second editions. This edition constitutes a technical revision which brings this standard in line with IEC 60601-1:2005+A1:2012 and its collateral standards.
| Regulation Number | Device Name | Device Class | Product Code |
| §892.5700 | System, Applicator, Radionuclide, Remote-Controlled | Class 2 | JAQ |
| There is no relevant guidance developed at this time. |