- 1. Scope of application: The stability study of passive implanted medical devices and the preparation of relevant registration application materials. The stability study generally includes shelf life, service stability and transport stability.
- 2. Definition
- 2.1 Shelf life: The verification test of shelf life of medical devices can usually be divided into two categories: Accelerated stability tests and real-time stability tests.
Accelerated stability test:
AAT: accelerated aging time.
RT: real-time aging time.
Q10: Aging coefficient increases or decreases by 10℃; Q10 is generally set to 2, but can also be conservatively set to 1.8.
TAA: accelerated aging temperature. Generally, the accelerated aging temperature should not exceed 60℃.
TRT: preset actual storage temperature. The relative humidity is generally recommended to be 60%±10%, and it is recommended to verify the performance of the product under the most adverse conditions.
2.2 Stability of use: To maintain its safety and effectiveness through the life cycle of normal use, maintenance (if applicable).
2.3 Transportation stability: Transportation stability is usually carried out through simulated transportation tests. By simulating changes in the environment (temperature, humidity, air pressure, etc.), drop, collision, vibration, acceleration, during transportation, the product will not change in performance and function, and the packaging system has the ability to protect the product.
Guidelines for Stability Studies of Passive Implantable Medical Devices (Revised Edition 2022)