Good day to all!
Recently we've reproduced our medical device into medical system (due to new registration process for another zone). It could be defined as a one, because of having several parts (devices) with power and functional connections between them. So we needed do assess these parts, which of them are medical devices, and should comply to IEC 60601, which are non-medical and should comply to appropriate IEC / ISO etc. standards.
According to section 16 of IEC 60601-1, we need to test non-medical devices in patient environment against IEC 60601-1 requirements. And it is fine by me. But for non-medical devices which aren't in this environment, we need to define standards or regulation requirements (which is possible due to most of them having some certification already) and provide different tests. I'd like to test these devices against 60601-1 without these troubles with other standards (We've done that earlier, when we considered our system as a "device") , but I can't find any permission to apply it in section 16 or any other parts of IEC 60601-1.
Usually requirements for medical devices are a lot more strict, than for basic low voltage equipment or industrial electronics, so I guess, that my path to test the system should be fine. But If the CB reviewer would go to strictly about IEC 60601-1 compliance, He could easily rise NC for this.
I was thinking of writing justification by providing gap analysis between IEC 60601 requirements and other applicable Standards requirements for these non-medical devices, but it will take much time and effort, epspecially as I am not very much proficient in some low voltage and industrial standards.
So, have anyone here get into alike sitaution? Do you have any experience about conformity approval of such systems? I'd like to get any clarification about similar situations.
Recently we've reproduced our medical device into medical system (due to new registration process for another zone). It could be defined as a one, because of having several parts (devices) with power and functional connections between them. So we needed do assess these parts, which of them are medical devices, and should comply to IEC 60601, which are non-medical and should comply to appropriate IEC / ISO etc. standards.
According to section 16 of IEC 60601-1, we need to test non-medical devices in patient environment against IEC 60601-1 requirements. And it is fine by me. But for non-medical devices which aren't in this environment, we need to define standards or regulation requirements (which is possible due to most of them having some certification already) and provide different tests. I'd like to test these devices against 60601-1 without these troubles with other standards (We've done that earlier, when we considered our system as a "device") , but I can't find any permission to apply it in section 16 or any other parts of IEC 60601-1.
Usually requirements for medical devices are a lot more strict, than for basic low voltage equipment or industrial electronics, so I guess, that my path to test the system should be fine. But If the CB reviewer would go to strictly about IEC 60601-1 compliance, He could easily rise NC for this.
I was thinking of writing justification by providing gap analysis between IEC 60601 requirements and other applicable Standards requirements for these non-medical devices, but it will take much time and effort, epspecially as I am not very much proficient in some low voltage and industrial standards.
So, have anyone here get into alike sitaution? Do you have any experience about conformity approval of such systems? I'd like to get any clarification about similar situations.
