Earlier this year, the IEC finalized and published the latest edition of IEC 60601-1-11:2015, the Collateral standard for medical devices used in the Home Healthcare environments. Manufacturers of applicable devices need to consider the additional risks posed as more devices move to support patients and health outside of the clinical environment, including ease of use, software compatibility and additional environmental hazards.

Many of the changes reflected in the new edition are based on updates to either the part 1 document and amendment 1 or updates to other collaterals such as 60601-1-2, 4th edition.

High level additions to the collateral standard that may impact manufacturers of medical devices to be used in the home healthcare environment are:

  • General requirements (section 4) now includes requirements  a rated range for both 12 V dc and 24 Vdc supply mains.  12 Vdc and 24 Vdc supply mains connected equipment shall maintain BASIC SAFETY and ESSENTIAL PERFORMANCE during and following a specified voltage dip.
  •  The standard has been updated to allow symbols related to temperature and humidity ranges.
  •  Section 8.5 requires indication of state of internal power source
  • Clarifies that Table 28 (Mechanical Strength test applicability) of the Part 1 Standard is applied in  addition to Tables 1 and 2 of the IEC 60601-1-11:2-15

 

The changes will impact manufacturers of products employing Internal Power Sources, that will need to consider the additions in the General requirements to ensure their device maintain BASIC SAFETY and ESSENTIAL PERFORMANCE during voltage dips.

For this and other new standards that apply to medical devices, the acceptance of each edition is determined by the applicable regulatory body in the markets where the products are being sold.

UL technical experts participate on the international standards committees and are in the best position to help you with your specific device questions.  UL provides full services to support testing, certification, regulatory strategy, human factors engineering (usability) and validation of devices intended for use in the home environment.  For more information, please contact us at:  Medical.Inquiry@ul.com or find your local contact at:  https://industries.ul.com/blog/directory-of-contacts-for-ul-health-sciences-division


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