IEC 60601-2-2 | Electrosurgical Accessory Testing
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 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 also tests electrosurgical (monopolar and bipolar) active accessories and cables.
Test Standards for Electrosurgical Accessories
Until a few years ago, ANSI/AAMI HF18 was the most widely used standard for electrosurgical accessories in the United States. Its requirements evolved since its first edition in 1986, and it had long been recognized by the U.S. Food and Drug Administration (FDA). The international standard, IEC 60601-2-2, was developed more recently, but its third edition (1998) suffered from a number of shortcomings when compared with HF18, and it was largely ignored, especially in the United States.
A new, fourth, edition of IEC 60601-2-2 was issued in 2006, with heavy participation from the U.S. delegation (which had also served on the HF18 committee). The changes from the IEC third edition reflect much of the philosophy of AAMI HF18. Accordingly, in early 2007, AAMI officially withdrew HF18:2001 as a standard and removed it from sale. FDA has officially recognized IEC 60601-2-2:2006 and withdrawn its recognition of ANSI/AAMI HF18:2001. Therefore, 510(k) submissions for electrosurgical devices should include testing to the IEC standard, rather than the AAMI standard.
IEC standards for specific electromedical devices (such as IEC 60601-2-2) are “keyed” to the general standard for electromedical devices, IEC 60601-1. The first 4 editions of IEC 60601-2-2 were keyed to the 2nd (1988) edition of 60601-1. But a 3rd edition of IEC 60601-1 was issued in 2005; it is totally reorganized to focus on risk management. This reorganization required revision of all subsidiary standards, such as IEC 60601-2-2.
The 5th edition of IEC 60601-2-2, which is linked to IEC 60601-1:2005, was issued in 2009. DDL has compared the 4th and 5th editions of 60601-2-2 carefully. While the clause numbers are very different and there are small differences in language, there are NO DIFFERENCES in the testing requirements for electrosurgical active accessories or return electrodes. Our test reports can refer to either edition of 60601-2-2, as the client prefers. The FDA has recently recognized the new editions of both 60601-1 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 two 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 the rated voltage. To justify this reduction in safety factor, IEC 60601-2-2:2006 places certain restrictions on the test waveform. DDL's testing meets the new restrictions. In addition, the IEC standard requires that the high-frequency test be performed 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, the mains-frequency test voltage depends on the high-frequency voltage rating.
The bottom line
DDL can test electrosurgical accessories against either IEC 60601-2-2 or ANSI/AAMI HF18:2001. Most of our clients now opt for the IEC testing. The main advantage is that the high-frequency dielectric withstand test is done at a much lower voltage. Clients who are developing a new product and do not know what rating to specify can take advantage of a test protocol developed by CITECH that establishes an appropriate voltage rating. Contact us for more details.