New IEC 60601-1-11 Standard Addresses Home Healthcare Environment

September 12, 2012 – 10:30 am

IEC 60601-1-11, which became mandatory in the European Union on 1 June 2012, outlines new requirements for the design and verification of a range of home use and point-of-care medical devices, notes SGS Medical Devices Services. The new standard differs from the general IEC 60601-1 in relation to requirements for construction and testing of the device, adds the inspection, verification, testing and certification company.

The IEC 60601-1-11 standard defines the Home Healthcare Environment as the “dwelling place in which a patient lives or other places where patients are present, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present.” (The definition of the US national version differs slightly and its implementation date is 30 June 2013.)

Medical devices typically mandated to use the new standard include oxygen concentrators, body-worn nerve and muscle stimulators, beds, sleep apnea monitors and battery chargers prescribed for use at home, according to SGS.

For devices intended for home use, the new standard requires the use of a two-prong (unearthed) plug and water-resistant casings. Also, parts that are applied to a patient must be isolated from other parts of the device. The devices also must be tested to withstand mechanical shock, vibration, impact from dropping and a range of environmental conditions. These requirements go beyond the general 60601-1 standard, and a design review is recommended to ensure compliance across the entire range of new requirements. Simply addressing the general risk concerns of ISO 14971 is no longer adequate to comply with the specific hardware-related aspects of IEC 60601, says SGS.

IEC 60601 3rd edition series has, and still is, undergoing changes with a recent amendment to the general requirements standard IEC 60601-1, which modifies and clarifies some of the existing requirements. SGS recommends that manufacturers perform a thorough review of any new, or existing, devices intended for the European or North American markets.

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  1. 2 Responses to “New IEC 60601-1-11 Standard Addresses Home Healthcare Environment”

  2. Could you explain what you meant under “mandatory”, it seems to me to contrast with what reported on the document “Frequently asked Questions related to the Implementation of EN 60601-1:2006 with respect to MDD 93/42/EEC” V1.1 – 2012-02-06 by NB-MED, which I believe is widely accepted. Thank you.

    Question 3.4.2:
    What about Collateral standards without an edition relating to the 2nd edition?
    For a specific group of MEE and MES a first edition of a collateral standard relates to EN 60601-1:2006 and is work in progress or has recently been published. For these collaterals, there are no editions available relating to the 2nd edition
    [...]
    - EN 60601-1-11: collateral standard for MEE and MES used in the home healthcare environment (published in the OJ list since 18. January 2011)
    [...]
    Is there any guidance beyond the general advice to discuss specific problems related to the application of these new collateral standards with the NB and using Risk Management?
    What transition period can be expected for the application of those collaterals?
    Answer 3.4.2:
    If a totally new collateral standard, a part 1, is published and listed in the OJ, there is no indication of a transition period. However, where there is no part 2, it is recommended that the NB accommodates an adoption period of 3 years after the date of ratification of the EN. This date of ratification can be found at the CENELEC website (www.cenelec.eu).

    By pm on Sep 13, 2012

  3. PM: I have asked SGS to respond to your request, as it issued the press release, but have yet to hear back. I will keep trying. Thanks for your interest!

    By Norbert Sparrow on Sep 18, 2012

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