| IEC 60601-2-34 Edition 3.0 2011-05 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment |
| Recognition Date | 2013-08-06 |
| Recognition List | 031 |
| Recognition Number | 3-115 |
| Extent | Complete standard |
| Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
| STG | Cardiovascular |
| FDA Tech | Charles Ho FDA/OMPT/CDRH/ODE/DCD/CDDB/ 301-796-6320 charles.ho@fda.hhs.gov |
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IEC 60601-2-34:2011 concerns the basic safety and essential performance of invasive blood pressure monitoring equipment. It amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The third edition of IEC 60601-2-34 cancels and replaces the second edition published in 2001 and constitutes a technical revision in order to align structurally with the 2005 edition of IEC 60601-1. IEC 60601-2-34 applies to basic safety and essential performance of invasive blood pressure monitoring equipment. It does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables connected. It does not apply to non-invasive blood pressure monitoring equipment.
| Regulation Number | Device Name | Device Class | Product Code |
| §870.2870 | Transducer, Pressure, Catheter Tip | Class 2 | DXO |
| §870.2850 | Transducer, Blood-Pressure, Extravascular | Class 2 | DRS |
| §870.2060 | Amplifier And Signal Conditioner, Transducer Signal | Class 2 | DRQ |
| §870.1110 | Computer, Blood-Pressure | Class 2 | DSK |
| There is no relevant guidance developed at this time. |