Medical Equipment and Medical Systems Industry Testing
Medical Devices must adhere to strict certification testing standards to ensure proper product operation and interaction with other devices both medical and non-medical. Various testing types include EMC/EMI, shielding effectiveness, ingress protection, climatic, dynamic, and package integrity testing.
In the United States, medical devices must meet Food and Drug Administration (FDA) standards. In Europe, the requirements include the Medical Devices Directive and IEC 60601-1-2, which are the recognized standards for testing the electromagnetic compatibility of medical devices.
A medical device is any instrument, apparatus, appliance, material, or another article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of or compensation for any injury or handicap;
- investigation, replacement or modification of the anatomy or of a physiological process;
- control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
EMC Testing of Medical Devices Includes the Following Tests Under IEC 60601-1-2:
- Electro-static Discharge (ESD)
- Radiated Immunity/Radiated Emissions
- Conducted Immunity/Conducted Emissions
- Electrical Fast Transient
- Lightning and Surge
- Harmonics and Flicker
- Power Frequency Magnetic Fields (voltage dips, interruptions, and variations)
It is important to note that in addition to EN 60601, there are dozens of additional standards that address unique features and characteristics of medical devices.
Product Safety Testing of Medical Devices:
- EN 60601-1-2 Medical Electrical Equipment – Part 1-2: EMC Testing of Medical Electronic Equipment
- IEC 60601-1-3 Medical Electrical Equipment – Part 1-3: Testing of Diagnostic X-Ray Equipment
- IEC 60601-1-6 Medical Electrical Equipment – Part 1-6: Collateral Standard: Usability
- IEC 60601-1-8 Medical Electrical Equipment – Part 1-8: Alarm Systems
- IEC 60601-1-9 Medical Electrical Equipment – Part 1-9: Environmental Testing
- IEC 60601-1-10 Medical Electrical Equipment – Part 1-10: Physiologic Closed-loop Controllers
- IEC 60601-1-11 Medical Electrical Equipment – Part 1-11: Home Healthcare Environment
- IEC 60601-1-12 Medical Electrical Equipment – Part 1-12: Emergency Medical Services Environment
- IEC 60601-2-10 Medical Electrical Equipment – Part 2-10: Nerve and Muscle Stimulators
- IEC 60601-2-18 Medical Electrical Equipment – Part 2-18: Endoscopic Equipment
- IEC 60601-2-25 Medical Electrical Equipment – Part 2-25: Electrocardiographs
- IEC 60601-2-27 Medical Electrical Equipment – Part 2-27: Electrocardiographic Monitoring Equipment
- IEC 60601-2-46 Medical Electrical Equipment – Part 2-46: Operating Tables
- IEC 60601-2-47 Medical Electrical Equipment – Part 2-47: Ambulatory Electrocardiographic Systems
- IEC 60601-2-60 Medical Electrical Equipment – Part 2-60: Dental Equipment
Environmental Testing of Medical Devices Includes the Following Tests:
Package Integrity Testing of Medical Devices
In assessing the environmental and EMC test requirements of a medical device, it is important to understand the definitions of medical device and accessory.
An accessory is defined as an article that while not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.
Expert Regulatory Compliance Testing
Keystone Compliance assists medical device manufacturers with EMC and environmental compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your needs. In addition to electromagnetic and environmental testing, Keystone has an extensive scope of medical device-related package testing standards to meet any distribution testing needs.