EN 60601-2-2
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DIN EN 60601-2-2 |
|---|---|
| Area | Medical technology |
| title | Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment and HF surgical accessories |
| Brief description: | Requirements and test instructions to ensure the safety of HF surgical devices and accessories |
| Latest edition | 2010-01 |
| ISO | IEC 60601-2-2 |
The EN 60601-2-2 with the title "Medical electrical devices - Part 2-2: Special provisions for the safety of high-frequency surgical devices " is part of the EN 60601 series of standards .
The German Institute for Standardization is the publisher of the DIN standard DIN EN 60601-2-2 .
The standard is based on the international version IEC 60601-2-2. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-2 , see DIN-VDE standards part 7 .
This supplementary standard regulates general requirements for safety, tests and guidelines for high-frequency surgical devices.
Valid in Germany
- The current version (2010-01) is only to be used together with the 3rd edition of DIN EN 60601-1 from 2007.
- The previous standard 2007-09 is only to be used together with the 2nd edition of DIN EN 60601-1.
- DIN EN 60601-2-2 (VDE 0750-2-2): 2007-09 can still be used until April 2012.
scope of application
The standard specifies special requirements for the safety of HF surgical devices and HF surgical accessories for medical use. It is to be used together with EN 60601-1 (3rd edition). EN 60601-2-18 (in parts) must also be used for endoscopic accessories .
Devices with an output power of less than 50 watts are excluded from certain requirements.
extra information
English is often referred to as RF surgery . RF stands for "radio frequency".