IEC 61010-1 and IEC 60601 - Borderline Medical Device

spectra123 · Feb 14, 2012

Hi,

Our device a medical device based on borderline criteria and has been tested using standards 61010-1-2001 and 60601 2nd edition. We are currently in the process of obtaining an EC certificate. Should we retest to 61010-1-2010? Also, 61010-1 is not listed as a harmonized standard in EU. Any thoughts? Thanks for everyone's help and input.

Best.

Hershal · Feb 14, 2012

Re: 61010-1 and 60601 - borderline medical device

Check with the certification body doing the product certification and get their recommendation. After all, the certification by a Guide 65 accredited organization may have some weight in the EC decision, especially as 61010 comes in under the CB Scheme.

Pads38 · Feb 15, 2012

If your device is a electrical medical device then the harmonized standard to use to show compliance with the Medical Device Directive is 60601-1. As the cut-of date for the use of the 2nd edition (1990) is the 1st of June this year you really need to use edition 3 (2005/6).

If your device is NOT a medical device (perhaps it is medical laboratory equipment) then the harmonized standard to use to show compliance with the Low Voltage Directive is 61010.

So different standards for different directives, depending upon what your device is.

spectra123 · Feb 15, 2012

Pads38 said:
If your device is a electrical medical device then the harmonized standard to use to show compliance with the Medical Device Directive is 60601-1. As the cut-of date for the use of the 2nd edition (1990) is the 1st of June this year you really need to use edition 3 (2005/6).

If your device is NOT a medical device (perhaps it is medical laboratory equipment) then the harmonized standard to use to show compliance with the Low Voltage Directive is 61010.

So different standards for different directives, depending upon what your device is.

Thank you very much Pads38 and Hershal for the info. Since our device is a Class IIa medical device under EU borderline classification, should we show compliance to 60101? Our device has no patient contact. How much is 61010 different from 60601? Also, I am finding that 61010-1 is not a harmonized standard for FDA medical devices or MDD. We currently has testing certificates for both 61010-1/2001 and 60601-1/2003. Any help will be greatly appreciated.

Thanks.

Marcelo · Feb 15, 2012

If your device is NOT a medical device (perhaps it is medical laboratory equipment)

Please note that medical laboratory equipment is considered a medical device. But it may be under the IVD Directive.

Marcelo · Feb 15, 2012

Thank you very much Pads38 and Hershal for the info. Since our device is a Class IIa medical device under EU borderline classification, should we show compliance to 60101? Our device has no patient contact. How much is 61010 different from 60601? Also, I am finding that 61010-1 is not a harmonized standard for FDA medical devices or MDD. We currently has testing certificates for both 61010-1/2001 and 60601-1/2003. Any help will be greatly appreciated.

What does you medical device do? There's no way both 60601 and 61010 applies to it because they exclude one another.

The problem is that some NBs, not knowing what to do, asks for both. Weird.

spectra123 · Feb 15, 2012

Marcelo Antunes said:
What does you medical device do? There's no way both 60601 and 61010 applies to it because they exclude one another.

The problem is that some NBs, not knowing what to do, asks for both. Weird.

Our device is a laser used during IVF. It is classified as Class IIa under MDD (borderline classification) and we have it approved as a 510k approved Class II device. The FDA special controls guidance document lists both standards 60601-1 and 61010-1 for electrical safety. Could you please elaborate on how the two standards exclude one another? Thanks for your help.

Marcelo · Feb 15, 2012

Could you please elaborate on how the two standards exclude one another? Thanks for your help.

From IEC 61010

1.1.2 Equipment excluded from scope

This standard does not apply to equipment within the scope of:

f) IEC 60601 (Medical electrical equipment);

So an equipment is a medical electrical equipment under 60601 or an electrical medical device under 61010.

The FDA special controls guidance document lists both standards 60601-1 and 61010-1 for electrical safety

The guide say:

8. Electrical Equipment Safety
We recommend that you address the electrical equipment safety, e.g., electrical and mechanical safety, of your device by following one or more of the standards identified next or by equivalent methods:

- International Electrotechnical Commission (IEC) 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety

- IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements

- Underwriters Laboratory (UL) 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety

- American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ES-1 Safe current limits for electromedical apparatus (electrical safety only).

The features and design of your device will determine which of the above standards you should use and whether other standards or methods are appropriate in addition to or in place of these standards. The Obstetrics and Gynecology Devices Branch is available to answer any question you may have about which standards are appropriate for your device’s features and design.

Meaning, depending on your design and features, it can be a medical electrical equipment (60601) or a electrical medical device (61010).

Again, using the principles of the standards themselves, if's one is applicable, the other isn't.

IF FDA want you to use both, they surely can override this, but this seems unlikely to me.

spectra123 · Feb 17, 2012

Thank you very much for clarifying and answering my query. I still have a few questions. What is the difference between a medical electrical equipment and a electrical medical device? Is it mainly patient contact? 61010-1 is not a harmonized standard for EU or a consensus standard for FDA, even though FDA lists it in their guidance document. Is is okay to test our device against that standard?

Thanks.

Marcelo · Feb 22, 2012

What is the difference between a medical electrical equipment and a electrical medical device? Is it mainly patient contact?

No. Form the definition, a MEE can have an APPLIED PART or transfer energy to or from the PATIENT or detect such energy transfer to or from the PATIENT.

The applied part is the usual "patient contact" )although, for the new edition, even parts which do not always contact the patient can, in some cases, be applied parts, based on risk management).

61010-1 is not a harmonized standard for EU or a consensus standard for FDA, even though FDA lists it in their guidance document. Is is okay to test our device against that standard?

It´s always ok to test your device against anything, for example, any standard you want to.

Using an harmonized standard in the EU, for example, gives you presumption of conformity with the related essential requirements. If you do not use an harmonized standard, you have to show - justify, thru your risk management, that the level of safety you obtained is the same as if using an harmonized standard.So yes, you can use a non-harmonized standard, but you need to justify why.

IEC 61010-1 and IEC 60601 - Borderline Medical Device

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