1. What is the shelf life of medical devices?
Refers to the period of time during which a medical device can play its intended role after it has formed a final product. The end point of the shelf life is the product expiration date. After this period, the medical device may no longer have the expected performance parameters and functions.
2. What are the factors that affect the validity period of medical device shelves?
External factors mainly include: storage conditions, transportation conditions, production methods, production environment, packaging, the impact of changes in raw and auxiliary materials, and other influencing factors.
Internal factors mainly include:
the properties of each raw material component in a medical device;
possible interactions between raw material components in medical devices;
possible interactions between raw materials and components in medical devices and packaging materials (including preservation media, such as contact lens preservation solutions, etc.);
the impact of the production process on the raw materials, components and packaging materials in the medical device;
the effects of radioactive substances contained in medical devices and their by-products after radioactive decay on raw materials, components, and packaging materials in medical devices;
Ability to maintain microbial barriers in aseptic packaging products.
Both internal and external factors can affect the technical performance indicators of medical device products to varying degrees, and when the tolerance is exceeded, it can cause device failure.
It is important to emphasize that not all medical devices need to have a definite shelf life. When the raw material properties and packaging material properties of a medical device do not change significantly over time, it may not be necessary to determine a strict shelf life, and when a medical device is less stable or the risk of clinical use is too high, its shelf life needs to be rigorously verified.
3. What are the types of verification tests for the expiration date of medical device shelves?
The types of verification tests for the shelf life of medical devices can usually be divided into two categories: accelerated stability tests and real-time stability tests.
(1) Accelerated stability test
The accelerated stability test refers to the test in which a product is placed in an external stress state, and the material degradation under the stress state is investigated, and the material degradation of the product under normal storage conditions is inferred by using the relationship between the known acceleration factor and the degradation rate.
It should be noted that when the raw material components of medical devices are prone to degradation and damage at high temperatures, accelerated stability tests should not be used to verify their shelf life.
(2) Real-time stability test
Real-time stability testing refers to the placement of a product under predetermined storage conditions until its performance indicators are monitored to meet the specified requirements.
In the real-time stability test, the registration applicant shall determine the appropriate temperature, humidity, light and other conditions according to the actual production, transportation and storage of the product, and test the product within the set time interval. Due to the climate of most parts of China, the recommended temperature and humidity conditions set in the verification test are: 25 2, 60%RH 10%RH.
Real-time stability testing and accelerated stability testing of passive implantable medical devices should be performed simultaneously. The results of the real-time stability test are direct evidence to verify the shelf life of the product. When the results of the accelerated stability test are inconsistent with the results, the real-time stability test results shall prevail.
4. Which medical devices need to be approved for clinical trials?
The medical devices specified in the Notice on the Issuance of the Catalogue of Class III Medical Devices Subject to Clinical Trial Approval (formerly Circular No. 14 of 2014 of the State Food and Drug Administration) are subject to clinical trial approval.
5. What are the types of verification tests, testing and evaluation items for the validity period of medical device shelves? The testing items include the performance testing of the product itself and the performance testing of the packaging system.
The physical and chemical testing items closely related to the validity period of the medical device shelf need to be selected for the performance testing of the product itself, and the biological evaluation of medical devices involving medical devices whose biocompatibility may be changed is required. If applicable, package closure integrity testing can be used as an alternative to sterility testing.
Systematic packaging testing includes testing items such as package integrity, package strength, and microbial barrier performance.
6. What are the reference standards for verification tests for the validity period of medical device shelves?
1) Basic requirements and quality system standards.
ISO 11607-1 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems, and packaging systems;
ISO 11607-2 Packaging for terminally sterilized medical devices Part 2: Requirements for the qualification of forming, sealing, and assembly processes.
2) Standards for test methods for packaging systems.
1.YY T 0681 Test Methods for Packaging of Sterile Medical Devices Part 1-5;
2.ASTM D 4169 "Performance Testing of Transport Containers and Systems";
3.ASTM F 1608 Test for Microbial Penetration Levels of Breathable Packaging Materials.
4.YY T 0698 "Packaging Materials for Terminally Sterilized Medical Devices" Part 2-10.
7. How to extend the shelf life of medical device products?
See GB T 114178-2012 "Ophthalmic Optics Contact Lenses Part 8: Determination of Expiration Date" to carry out shelf life research. A complete real-time aging study report is required at the time of declaration.
8. If the validity period of medical device products is shortened, is it not necessary to submit technical documents in the application for change of license items?
Although the risk of quality changes during the storage cycle is reduced after the shelf life of the product is shortened, the registrant is advised to provide reasonable explanations and necessary supporting materials when applying for changes in licensing matters, such as finding that the shelf life of the product should be shortened after completing the real-time stability test, and it is recommended to provide the verification data of the real-time stability test.
If you have the sterilization, disinfection, and testing needs of the above medical devices, please leave a comment or contact by private message.