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Medical Industry Brief: IEC 60601-1-11 Home Healthcare Environment

Posted by TUV Rheinland on Mar 15, 2016 10:00:00 AM
TUV Rheinland

Home Healthcare

The near-universal adoption of high-speed broadband internet and telephone networks, smartphones and the tsunami of apps both entertaining and practical, as well as affordable electronic devices have all opened the doors for moving healthcare from the hospitals to home.

As populations continue to age and life expectancy increases, more and more patients need affordable, reliable and convenient professional medical services at home.

Those who benefit from home health care most are patients recovering from a hospital stay who would prefer to recuperate at home (for comfort and to reduce medical bills), those who are disabled, or patients with complex treatments or chronic diseases that require use of medical equipment and/or medication monitoring.

Historically, healthcare environments included hospitals and nursing homes and are considered "professional" healthcare environments. For patients requiring home care, these non-healthcare facility environments have different regulatory needs that are covered by Collateral Standard IEC 60601-1-11:

  • Environmental considerations (environmental conditions in a clinical setting are controlled vs products used in a home environment do not have such assurance: Additional requirements related to sterilization, excessive temperatures, or ingress of water must be assessed)
  • Use Considerations (home users are not assumed to be trained in a way professional users in a clinical environment are)
  • Design Considerations (mains supply fluctuations and non-reliable PE-grounding in a home environment, additional requirements for mechanical strength, alarm systems/signals)
  • Human Factors (FDA guidance for Risk Management related to human factors and usability)

To read more on this topic or to learn about the services TÜV Rheinland can offer, visit our website or contact us to speak to one of our experts today.

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Topics: medical, healthcare