Developing and introducing a new clinical diagnostic instrument or medical device is a challenging accomplishment that often takes years. One of the final steps in bringing life-saving, life-improving equipment to the public is US FDA listing and CE marking processes that ensure the safety of these devices as well as their compliance to well-established global standards. Trouble at this stage of the project can lead to frustrating and costly delays for medical device manufacturers. Examples of complications that may be found at this stage are electrical emissions or immunity issues that might only become apparent when all the pieces come together for final testing.
This blog explores standards required for the safety and performance of medical electrical equipment and discusses the benefits of choosing components, such as pumps, that are IEC-60601 compliant.
The International Electrotechnical Commission (IEC) is an organization that publishes international standards for all electrical, electronic, and other related technologies. In 1977, IEC published the IEC 60601 and it is continually updated as technology develops and improvements are made. Today, IEC 60601 is the international standard for the safety and performance of medical electrical equipment in most major countries. This standard is very important in that it provides compliance with US-FDA, Canada-Health Canada, and EEU Medical Device Directive 2007/47/EC regulations. IEC 60601 is currently in its 3rd revision (60601-1-11:2015) and certification can be obtained through an OSHA-approved testing laboratory.
Across the globe, medical regulating bodies, such as the FDA, EEU, and Canada-Health Canada, are responsible for ensuring the efficacy of the devices being designed and manufactured by OEMs. These regulating bodies have widely accepted the IEC-60601 standard as a benchmark for the basic safety and essential performance of medical electrical equipment for commercialization.
The 60601-1-11:2015 acts as risk management for the product design, manufacture, and intended use by requiring safety by design with protective measures in the medical device and calling for instructions or safety labeling. This standard provides customers with the assurance that the product is safe and reliable.
There are two types of products that fall under IEC-60601: Medical electrical equipment and medical electrical systems. Medical electrical equipment is defined as:
“Equipment, provided with not more than one connection to a particular supply main and intended to diagnose, treat, or monitor the patient under medical supervision and which makes physical or electrical contact with the patient and/or transfers energy to or from the patient and/or detects such energy transfer to or from the patient”.
— IEC 60601-1 subclause 2.2.15
A medical electrical system is defined as:
“Combination, as specified by its manufacturer, of items of equipment, at least one of which is Medical Equipment to be inter-connected by functional connection by use of a Multiple Socket-Outlet”.
— Nicholas Abbondante, chief engineer, EMC Testing for medical devices, Intertek Group, plc.
When selecting a component for your device, it is important to research the required standards. The IEC-60601-1-2 is the standard mandating that EMC testing is performed on any electronic medical device, which ensures that a device meets necessary emissions and immunity standards by the FDA to sell the device.
For medical device manufacturers, partnering with a supplier that offers compliant components, improves efficiency and reduces costs. Requesting a component manufacturer to obtain the specific compliance standards can result in expensive delays in the project scheduling process.
Miniature pumps, for example, are critical electromechanical components frequently used in medical devices. Pumps needed in today’s medical equipment range from simple on/off devices that are used for a very short time frame to dynamic control devices that need to last several years of continuous operation.
The new BTX-Connect diaphragm pump from Parker Precision Fluidics has been tested to IEC-60601-1-2 standards to provide a seamless approval process for the completed device.
Specifically, the BTX-Connect miniature diaphragm pump was tested and passed the following standards and tests:
The BTX pump uses brushless DC motor technology for maximum reliability and control. The controller offers the most dynamic control range and communication capability available. This electrical component of the pump is subject to electromagnetic emissions and immunity, the very same as the medical equipment system of which it becomes a part. Other features include: