Electrosurgical Accessory Testing | IEC 60601-2-2:2006
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Description
DDL can test electrosurgical accessories against either IEC 60601-2-2 or ANSI/AAMI HF18:2001. Our testing is used to support 510(k) submissions and to justify CE marking. Most of our clients now opt for the IEC testing. Clients who are developing a new product and do not know what rating to specify can take advantage of a test protocol that establishes an appropriate voltage rating.
DDL tests electrosurgical (monopolar and bipolar) active accessories and cables. Our testing is used to support 510(k) submissions and to justify CE marking.
1-1 and 60601-2-2, and these will be mandatory soon for CE marking.
Dielectric withstand testing
The biggest change in dielectric withstand testing, between HF18-2001 and the 2 current editions of 60601-2-2, was the reduction in the test voltage from 150% of the rated voltage of the accessory to 120% of that voltage. To justify this reduction in safety factor, IEC 60601-2-2:2006 places certain restrictions on the test waveform. DDL testing meets the new restrictions. In addition, the IEC standard requires that the high-frequency test be done first, followed immediately by the mains-frequency (e.g., 60 Hz) testing. There is also a significant change in the mains-frequency test voltage. In HF18 and prior editions of 60601-2-2, the voltage was fixed. Now, it depends on the high-frequency voltage rating.
DDL tests electrosurgical (monopolar and bipolar) active accessories and cables. Our testing is used to support 510(k) submissions and to justify CE marking.
1-1 and 60601-2-2, and these will be mandatory soon for CE marking.
Dielectric withstand testing
The biggest change in dielectric withstand testing, between HF18-2001 and the 2 current editions of 60601-2-2, was the reduction in the test voltage from 150% of the rated voltage of the accessory to 120% of that voltage. To justify this reduction in safety factor, IEC 60601-2-2:2006 places certain restrictions on the test waveform. DDL testing meets the new restrictions. In addition, the IEC standard requires that the high-frequency test be done first, followed immediately by the mains-frequency (e.g., 60 Hz) testing. There is also a significant change in the mains-frequency test voltage. In HF18 and prior editions of 60601-2-2, the voltage was fixed. Now, it depends on the high-frequency voltage rating.
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Electrosurgical Accessory Testing | IEC 60601-2-2:2006
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