Results 3 found
March 20th, 2015
Home Healthcare Environment – IEC 60601-1-11

IEC 60601-1-11 “Requirements for medical electrical equipment and medical electrical systems used in home care applications” is used to demonstrate conformity for medical equipment intended to be used in the home environment. This collateral standard is aligned with the 3rd edition of IEC 60601-1. Why home healthcare? As the average age of life expectancy rises, the… read more

October 23rd, 2014
FDA Considerations for Home Use Devices

On August 5, 2014 the FDA published design considerations for devices intended to be used in the home.  This document calls to the medical device manufacturer’s attention areas that, due to the differences between use in a clinical environment and a home environment, should be considered in the design of the medical device.  These considerations… read more

March 16th, 2014
UL Experts Provide Insights into HFE and Medical Device Design

Medical devices manufactured today require significant attention to safety and human factors engineering that has not always been exercised in medical device design. IEC safety standards mandated by the general standard, IEC 60601-1, updated to the 3rd edition, and now Amendment No. 1 to that standard, require testing and verification of devices and essential performance,… read more