What is ISO 14117 - Active implantable medical devices about?
ISO 14117 discusses active implantable medical devices. Active implantable medical devices are manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure. ISO 14117 specifies test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia, tachycardia, and cardiac resynchronization in conjunction with transvenous lead systems. ISO 14117 specifies the performance limits of these devices, which are subject to interactions with EM emitters operating across the EM spectrum in the two following ranges:
- 0 Hz ≤ ƒ < 385 MHz
- 385 MHz ≤ ƒ ≤ 3 000 MHz
ISO 14117 also specifies requirements for the protection of these devices from EM fields encountered in a therapeutic environment and defines their required accompanying documentation, providing manufacturers of EM emitters with information about their expected level of immunity.
Who is ISO 14117 - Active implantable medical devices for?
ISO 14117 on the active implantable medical devices is useful for:
- Implantable medical device manufacturers
- Medical device test laboratories
- Quality control personnel
- Medical institutes
- Design engineers
- Research and development facilities
Why should you use ISO 14117 - Active implantable medical devices?
Medical implants are man-made devices, in contrast to a transplant, which is a transplanted biomedical tissue. The number and the types of electromagnetic (EM) emitters to which patients with active implantable cardiovascular devices are exposed in their day-to-day activities have proliferated over the past two decades. This trend is expected to continue. The interaction between these emitters and active implantable cardiovascular devices is an ongoing concern of patients, industry, and regulators, given the potential life-sustaining nature of these devices. The risks associated with such interactions include device inhibition or delivery of inappropriate therapy that, in the worst case, could result in serious injury or patient death. ISO 14117 introduces active implantable cardiovascular devices, most notably devices that perform the function of improving cardiac output by optimizing ventricular synchrony, in addition to performing pacemaker or ICD functions.
Although these devices can deliver an additional therapy with respect to pacemakers and ICD devices, most of their requirements concerning EM compatibility are similar so that, in most cases, the concepts that apply to pacemakers also apply to CRT-P devices, and the appropriate way to test a CRT-P device is similar to the way pacemakers are tested. Similarly, the concepts that apply to ICD devices mostly apply to CRT-D devices as well, so the appropriate way to test a CRT-D device is similar to the way ICD devices are tested. ISO 14117 allow manufacturers to evaluate the EM compatibility performance of a product and demonstrate that the product achieves an appropriate level of EM compatibility in uncontrolled EM environments that patients might encounter. Using ISO 14117 you can specify test methodologies for the evaluation of the electromagnetic compatibility of active implantable cardiovascular devices.
What’s changed since the last update?
BS ISO 14117:2019 supersedes BS ISO 14117:2012. BS ISO 14117:2019 includes some technical changes with respect to BS ISO 14117:2012. These include:
- New definitions added for interference mode and transient exposure
- The breakpoint between injected voltage testing and radiated testing reduced from 450 MHz to 385 MHz to account for new wireless services
- Modification and clarification of 4.4, temporary exposure to CW sources
- New 4.10 concerning transient exposure to low-frequency magnetic field sources
- Recognition of multiple electrode leads such as those with is-4 and df-4 connectors