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  • 1.  Harmonized Standard

    Posted 18-Aug-2017 03:26
    Hi All,

    When the IEC/ISO standard is not harmonized, is that mandatory to be tested as per that standard requirement?

    For example, ISO 80601-2-61 (Pulse oximeter), is not harmonized as per EN Official Journal. When the product (PMS or similar) include SpO2 module, should I test the product to meet this ISO 80601-2-61 requirement for getting CE Mark?

    Or Internal verification and validation report of SpO2 module will be sufficient for CE mark?

    Please provide your suggestions.

    Thanks in advance.



    ------------------------------
    Silambarasan Subramanian
    Senior Engineer - Quality & Regulatory Affairs
    Schiller Healthcare
    India
    ------------------------------


  • 2.  RE: Harmonized Standard

    Posted 21-Aug-2017 03:09
    Edited by Heikki Pitkanen 21-Aug-2017 03:09
    Dear Silambarasan,

    The priority here is to discuss the issue with your Notified Body.

    As a general advice, not all international standards are harmonized and the harmonization of many standards (e.g. in the IEC 60601-series) has been delayed by years for several reasons. However, the Essential Requirements of the Medical Device Directive (Annex I, Clause 2) state that "The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art." It is the IEC 60601-series of standards, and their newest editions, that are generally considered 'state of the art', what comes to safety of electromedical devices. The use of standards, harmonized or not, is not mandatory, but if you choose an alternative path for conformity, you need to present a solid rationale for your Notified Body that the methods you've used fulfill at least the same level of safety as the state of the art standard. Furthermore, using an accredited laboratory for safety testing reduces the risk of having an unsafe and nonconforming device. Your Notified Body may not accept any lower level of proof than accredited testing.

    What you lack, when leaning to an IEC or ISO standard instead of a harmonized EN version of the same standard, is the support provided by Annexes Z of the EN standards. These annexes provide a hint on what parts of the Essential Requirements the standard is considered to cover and, therefore, also provides a more unified approach for the various Notified Bodies to look into device safety. In the lack of an EN standard, it comes down to discussing with your Notified Body. 
    EN standards have also brought clarity on the date of "coming into effect" of a standard. Now that you don't have that support, again, talk to the Notified Body. They follow closely on the development of the international standards that fall within their scope of designation.

    Hopefully any of this information helps you further!

    ------------------------------
    Heikki Pitkänen
    Lean Entries, Ltd.
    Finland
    +358(44)2380006
    heikki.pitkanen@leanentries.com
    www.leanentries.com
    ------------------------------

    Original Message


  • 3.  RE: Harmonized Standard

    Posted 22-Aug-2017 01:54

    Thanks Mr. Heikki Pitkänen for the valuable information. This is really helpful. 

    Thanks,



    ------------------------------
    Silambarasan Subramanian
    Senior Engineer - Quality & Regulatory Affairs
    Schiller Healthcare
    India
    ------------------------------

    Original Message


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