Medical devices, particularly those that directly or indirectly come into contact with a patient's blood, sterile tissues, or mucous membranes, such as surgical knives, catheters, and implants, must be sterile. If the packaging is damaged or improperly sealed during transportation and storage, microorganisms (bacteria, fungi, etc.) can infiltrate, leading to contamination of the devices. Using contaminated devices may cause infections and even pose a threat to patients' lives. CIRS Testing offers a comprehensive suite of solutions for sterile packaging of medical devices, including microbiological, chemical, accelerated aging, physical and mechanical property, and transportation testing. This ensures patient safety and helps your products comply with regulations to enter global markets!

Main Aspects Covered by Sterile Packaging Testing:

1. Microbiological Testing

The purpose of microbiological testing for sterile packaging of medical devices is to verify the sterility and microbial barrier performance of the packaging. The main tests include:

• Sterility Testing: To confirm whether the sterilized product is sterile. Testing methods include ISO 11737-2 and USP 71, among others.
• Microbial Barrier Testing: To evaluate the packaging material's ability to block bacteria/fungi. Testing methods include ISO 11607-1 and ASTM F1608, etc.
• Microbial Load Testing: To detect the level of microbial contamination before sterilization, ensuring the effectiveness of the sterilization process. Testing methods include ISO 11737-1, etc.

2. Chemical Testing

The purpose of chemical testing for sterile packaging of medical devices is to ensure that the packaging materials are non-toxic and free from the risk of chemical substance migration. The main tests include:

Ethylene Oxide and Chloroethanol Residue Testing (ISO 10993-7): Applicable to packaging materials sterilized with ethylene oxide, this test confirms whether the residual amounts of ethylene oxide and chloroethanol in the sterilized packaging materials meet standard requirements.

Hazardous Chemical Substance Testing: To assess the content of hazardous substances in the packaging materials, such as lead, cadmium, mercury, phthalates, and REACH SVHC (Substances of Very High Concern).

3. Accelerated Aging Verification

Accelerated Aging Test (ASTM F1980): By subjecting the packaging to high temperatures for accelerated aging, this test verifies the packaging's performance after its nominal shelf life (e.g., 3 years, 5 years).

4. Physical and Mechanical Property Testing

Seal Strength - ASTM F88: To evaluate whether the seals on the packaging are uniform and secure.

Burst Testing - ASTM F1140: To detect the overall pressure-bearing capacity of the packaging.

Tear Resistance - ISO 1974: To assess the packaging material's resistance to tearing.

Dye Penetration - ASTM F1929: To detect the presence of minute leaks at the seals of porous material packaging.

5. Transportation Simulation Verification

ASTM D4169: This standard comprehensively simulates the hazards that may be encountered throughout the entire logistics chain from the factory to the end-user, including drops, vibrations, stacking pressures, concentrated impacts, and temperature and humidity changes. It offers different assurance levels and test intensities. Laboratories can customize the most suitable testing plan based on the product's characteristics, weight, and expected distribution environment. After testing, an integrity check is conducted again to ensure that the packaging remains intact throughout the entire supply chain.

If you need any assistance or have any questions, please get in touch with us via test@cirs-group.com.