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Hi,
We are developing a patient monitoring equipment(ECG, NIBP) which we intend to use along with Electrosurgery equipment. As per 60601-2-27 (ECG) and 60601-2-30 (NIBP) standards, we need to meet a couple of testsfor Electr-surgery compatibility. And we are complying with these tests. These standards also have 60601-2-2 (HF surgical equipment) as normative reference. In 60601-2-2 standard, some tests are given as guidance tests in annexure (Anex-BB) which manufacturer can use to check compatibility with the emissions from Electrosurgical equipments.
I was told that, we have to mandatorily qualify these tests also in order to comply with Electr-surgery compatibility. Can anybody provide information on whether these tests are mandatory or voluntary for complaince.
Thanks
We are developing a patient monitoring equipment(ECG, NIBP) which we intend to use along with Electrosurgery equipment. As per 60601-2-27 (ECG) and 60601-2-30 (NIBP) standards, we need to meet a couple of testsfor Electr-surgery compatibility. And we are complying with these tests. These standards also have 60601-2-2 (HF surgical equipment) as normative reference. In 60601-2-2 standard, some tests are given as guidance tests in annexure (Anex-BB) which manufacturer can use to check compatibility with the emissions from Electrosurgical equipments.
I was told that, we have to mandatorily qualify these tests also in order to comply with Electr-surgery compatibility. Can anybody provide information on whether these tests are mandatory or voluntary for complaince.
Thanks