How to select appropriate standards for Multi-Functional Physical Therapy Equipment

[Roland chung]

Hello folks,

There is a multi-functional physical therapy equipment with ultrasound, laser and electric stimulation functions. In principle, IEC 60601-2-5 for ultrasound physiotherapy, IEC 60601-2-22 for laser function and IEC 60601-2-10 for electric stimulation shall be applied. However, the new publication (compatible with the IEC 60601-1: 2005) of above mentioned particular standards are not in the same step. From IEC webstore, the stage of IEC 60601-2-10 Ed.2 is CCDV.

I was told the philosophy is that it is not possible to mix standards referring to different versions of IEC 60601 series. In my case, some functions of the equipment are suitable for 3rd edition, but other function is not. Could someone tell me how to deal with this situation?

Thanks and regards,
Roland

 

[Marc]

Re: How to select appropriate standards for Multi-Functional Physical Therapy Equipme

A quick "Bump". My Thanks in advance to anyone who can help with this one.

 

[Peter Selvey]

Re: How to select appropriate standards for Multi-Functional Physical Therapy Equipme

TUV SUD mentions in one of their documents that for Europe, you can wait until the set has all been updated and harmonized. This situation applies to several types of equipment such as patient monitors and diagnostic ultrasounds (e.g. with endoscopic applications).

In practice there will be some complications, for example equipment placed on the market with and without options, and the options trigger different particulars, which in turn trigger different "sets" of standards. Result is the same device may have to be tested for both new and old standards.

Also different regulations (FDA, Canada, Japan etc) might have different timing for recognition.

Also there are some standards like -2-30 (NIBP) where the scope is changed, and others like -2-56 (Temp) that never existed in the 601 series before. And finally there may be some cases where one particular is extremely delayed (like -2-10).

Finally there is some doubt about the legality of TUV SUD's advice in the context of the presumption of conformity. In the case where only one particular applies, there is a possible legal argument that the particular drives the transition date, since the particular standard makes a specific reference to the edition of the general standard. Thus, even though the general standard is withdrawn, it can still provide a presumption of conformity through this back door via the particular.

However, in the case of two or more particulars, this rationale does not work. For example the particular -2-10 makes no reference to -2-22. So there is no back door to allow withdrawn particular standards to still be applied.

Upshot is that I expect some flexibility and common sense to be applied. As long as you apply common sense, and opt towards the more strict approach (e.g. applying new standards earlier), I don't think any auditors will complain too much.

 

[Roland chung]

Re: How to select appropriate standards for Multi-Functional Physical Therapy Equipme

Many thanks for your input.

It makes sense to apply new standards earlier. BUT it will be very strange to use all new standards except for the 60601-2-10. I have no idea at all.

In your post, you mentioned 80601-2-30 (NIBP) has changed their scope. Did you mean that the blood pressure meter (this can be home use unit) with a single button to trigger the measurement every time (button--> inflation --> deflation --> reading) has also been included?

 

[Peter Selvey]

Re: How to select appropriate standards for Multi-Functional Physical Therapy Equipme

Yes, the scope for -2-30 has changed so that all types of NIBP are covered, not just the type that is used for automated cycling as in patient monitoring.

That situation results in a question about non-patient monitoring types of NIBP. Using the TUV SUD rule, you get a strange result: you would have to follow the deadline of the 3rd edition on June 2012 without 80601-2-30, and then later add -2-30 when it is harmonized and the deadline expires.