In the field of medical device packaging, ensuring the quality and safety of packaging bags is of paramount importance. Below are the comprehensive quality and technical requirements for medical device packaging bags, aimed at safeguarding the sterility, integrity, and traceability of medical products.

1. Microbial Barrier Performance

• Material Standards: Materials must effectively block microorganisms/bacteria, complying with ASTM F-1608 standards, to ensure the cleanliness and safety of the internal packaging environment.

2. Sterilization Compatibility

• Sterilization Method Adaptability: Packaging bags must be fully compatible with promised sterilization methods such as ISO 11134 (ethylene oxide sterilization), ISO 11135 (radiation sterilization), and ISO 11137 (steam sterilization), ensuring that the sterilization process does not compromise packaging integrity.

3. Sterility Maintenance Capability

• Protectiveness: Packaging must maintain the sterility of the product, preventing air contamination, fiber damage, dust, and other foreign matter as well as microbial invasion, in accordance with ASTM D-2019 standards.

• Packaging Integrity:

• Materials must be free from damage, ensuring the physical integrity of the packaging.

• Seals must be complete, with appropriate peel strength (complying with ASTM F88), no permeation (according to ASTM standard: 1998), no bursting (ASTM F-1150 / ASTM F-2054), and a clean peel process (EN868-5).

4. Processing Friendliness

• Material Handling: The manufacturing process of materials should minimize particle shedding, such as fibers, flakes, ink detachment, and dust, to ensure the purity of packaging materials (ASTM D-2019).

5. Tamper-Evident Design

• Opening Indication: After opening, packaging should leave a clear and irreversible trace, indicating that the packaging has been opened, to prevent contamination risks from illegal re-sealing.

• Non-Resealability: The design of the opening seal should ensure that once opened, it cannot be easily resealed, maintaining product safety and sterility.

6. Ease of Opening

• Clear Identification: The opening position and direction should be clearly marked, facilitating quick identification and correct opening of the packaging by users (EN980).

• Easy-to-Open Design: The opening process should be simple and straightforward, with the opening position conveniently located for user operation, enhancing the user experience.

7. Product Identifiability

• Printing Standards: Printed markings must comply with relevant medical device laws and regulations, ensuring accurate and readable information.

• Transparency Requirements: At least one side of the material should be transparent, allowing for direct viewing of the internal product, enhancing product traceability and identifiability (EN980).