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Home Medical Monitoring Device

IEC 60601-1-11 Home Healthcare Medical Electrical (ME) Equipment Testing

This international standard applies to the basic safety and essential performance of medical electrical equipment in the home healthcare environment. The home healthcare and tele-medical revolution is in full swing as hospitals struggle to keep up with a growing number of patients. 

The use of home diagnostic and therapy equipment is a necessary evolution to keep up with growing demand. As an IEC 60601 test lab, we know the importance of this shift to the market and offer support in planning and execution of the home healthcare specification.

Meeting the IEC testing requirements can be difficult. We understand the challenges and guide companies through the process. From preliminary design reviews to performance testing on our state of the art shock and vibration testers, we help customers get ahead and stay ahead in the home healthcare space. 

Request a quote to receive testing services customized to your specific needs. Have a question about medical and home healthcare testing? Contact us and we will determine the best course of action.

Summary of IEC 60601-1-11 Home Healthcare Testing

Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

IEC 60601-1-11 Introduction:

Medical practice increasingly uses medical electrical equipment and medical electrical (ME) systems for monitoring, treatment, or diagnosis of patients in the home healthcare environment. The safety of medical electrical equipment in this uncontrolled environment concerning the electrical installation and its related safety and protection means is a cause for concern.

IEC 60601-1-11 and EN 60601-1-11 testing procedures give special guidance on how this should be addressed in the instructions for use.

Within the two main categories are several sub-categories. These include mobile, portable, hand-held, and body-worn. The IEC 60601-11-1 transportation testing standard includes the following chart that displays the qualitative assessment of home healthcare medical equipment subjected to shock and vibration:

Non-Transit-Operable Use
 MobilePortableHand-HeldBody-Worn
Vibration1111
Shock1111
Drop1132

 

Transit-Operable Use
 MobilePortableHand-HeldBody-Worn
Vibration2221
Shock2232
Drop2233

Even the normal use of medical equipment in the home healthcare environment can be hazardous. Patients and their families, especially children, can be rough when handling equipment.

The Medical Electrical (ME) equipment collateral standard, IEC 60601-1-11, was developed with contributions from clinicians, engineers, and regulators.

The terminology, requirements, general recommendations, and guidance of EN 60601-1-11 are intended to be useful for manufacturers of medical electrical equipment and medical electrical systems and technical committees responsible for the development of particular standards.

Expert IEC 60601-1 Medical Equipment Laboratory Testing

Here at Keystone, we have experience with a variety of products. Our walk-in chambers can accommodate any size of equipment. We perform atmospheric conditioning and shock & vibration in house, limiting external testing and improving turnaround time.

Request a quote and find out first hand about our competitive pricing, timely process, and outstanding reputation. Contact us to receive more information on IEC medical equipment package testing.