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  • 1.  Definition of 'clinical function' in context with IEC 60601-1 3rd

    Posted 11-Jan-2013 04:24
    Revision 3.1 of IEC 60601-1 (Aug 2012) defines 'essential performance' as follows: performance of a clinical function, other than that related to BASIC SAFETY, where loss or degradation beyond the limits specified by the MANUFACTURER results in an unacceptable RISK.

    However there is no definition of the term 'clinical function' given in that standard.

    Is anyone aware of a definition of 'clinical function'?

    How do you understand this term and differentiate this updated understanding of 'essential performance' from 'functional safety' ?

    I would be interested also in how you put this into practice.

    Thanks in advance

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    Alexander Schwiersch
    Brainlab AG
    Feldkirchen
    Germany
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  • 2.  RE:Definition of 'clinical function' in context with IEC 60601-1 3rd

    Posted 12-Jan-2013 06:47
    I am not aware of a formal definition, but I believe I understand the distinction which is being made between the concepts of "clinical function" and "basic safety."

    Consider the case of a medical electrical device intended to provide therapy by imparting energy into a patient which has been damaged. If the device fails to deliver the energy owing to damage but does not present a safety hazard, (for example because a fuse has blown, when powered up nothing happens) it is no longer capable of the 'essential performance.' If it is capable of delivering the energy but is unsafe to use (for example if circuitry has become wet and the electronics throws sparks) then even it it may be capable of delivering the energy to the patient and capable of 'essential performance' it does not satisfy basic safety.

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    Jean Bigoney PHD
    Managing Member
    Nu Device Consulting LLC
    Newport NH
    United States
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  • 3.  RE:Definition of 'clinical function' in context with IEC 60601-1 3rd

    Posted 13-Jan-2013 04:32
    IEC has a great site with a glossary and defintion of terms used in IEC standards:
    http://std.iec.ch/glossary

    I did not find "clinical function" listed at this site.
    In any event, keep in mind that according to the 3rd edition, the loss or degredation will  result in an "unacceptable risk" as defined by the manufacturer as per ISO 14971.

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    Asher Kassel
    Lifewatch Technologies Ltd.
    Rehovot
    Israel
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  • 4.  RE:Definition of 'clinical function' in context with IEC 60601-1 3rd

    Posted 13-Jan-2013 10:57
    I got this in my inbox today and it may be helpful in resolving the question:

    http://www.aami.org/publications/AAMINews/Jan2013/60601-1_Amendment.html?goback=%2Egmp_2070960%2Egde_2070960_member_203299081

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    Jean Bigoney PHD
    Managing Member
    Nu Device Consulting LLC
    Newport NH
    United States
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  • 5.  RE:Definition of 'clinical function' in context with IEC 60601-1 3rd

    Posted 13-Jan-2013 11:46
    Regarding the question "How do you understand this term and differentiate this updated understanding of 'essential performance' from 'functional safety' ?" may I suggest reading through IEC/TR 60930 Edition 2.0, 2008-09?  The title of this Technical Report is "Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems".

    Though term "clinical function" did not appear in a word search, this standard may help in understanding this term and provide the differentiation you are seeking.

    I hope this helps.


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    John Beasley RAC
    Founder and Senior Consultant
    Medtech Review, LLC
    Henderson NV
    United States
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  • 6.  RE:Definition of 'clinical function' in context with IEC 60601-1 3rd

    Posted 13-Jan-2013 12:52
    As for compliance to IEC 60601-1 3rd Ed, Amended

    Manufacturer's essential performance requirements differ based on the intended use of the device.  

    Essential Performance should be interpreted as "performance functions leading to unacceptable risks based on your risk analysis as part of your Risk Management."  

    Clinical Function should be interpreted as "those features or functions suitable/necessary for the intended use of the device.  In other words, those features or functions required to render clinical benefits/utility/meaningfulness.  Collectively speaking, "effectiveness of the device."

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    Regulatory Doctor, Coach, Mentor, and Consultant
    www.GlobalComplianceSeminar.Com
    Riner VA
    United States



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