Journal of SMT Article
RELIABILITY CONSIDERATIONS FOR IMPLANTED MEDICAL ELECTRONICS
Company: Guidant Corporation
Date Published: 10/1/2005 Volume: 18-4
Therefore, the products must work consistently for long periods of time (in many cases > 10 years) without the benefit of downtime, battery recharging, or repair. In addition, the products should not cause patients adverse effects under any circumstances. While the implantable electronics device enjoys one of the most benign end use environments (37C +/- 2 degrees), the overall reliability concerns are extremely high.
Patients expect and deserve to lead a healthy and active life after receiving an implanted device. To further complicate matters, each patient provides a unique set of needs and requirements. Examples of unique needs include product therapy, patient age, weight, activity level, living environment, and regional/country regulatory requirements.
In an attempt to ensure a robust product, extreme reliability and process testing is required to prove long-term reliability. This paper discusses reliability requirements and approaches to assess long-term robustness of implantable medical devices.
Key words: medical, implantable, reliability.
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