What is the ISO 11607-1 Packaging Validation Test?

The development and design of sterile medical packaging is a complex and lengthy process. At the early design stage, careful consideration must be given to different sterilization methods, shelf life, transportation, and storage to ensure that the combination of the medical device and sterile packaging performs safely and effectively in the hands of healthcare professionals.

ISO 11607-1 establishes clear standards regarding user needs and usage environments, product characteristics, and packaging design. It outlines several key factors that must be taken into account, including:

- Quality and structure of the product

- Presence of sharp edges or protrusions

- Specific risk sensitivities of the product (e.g., radiation, moisture, mechanical vibration, static electricity)

- Sterilization compatibility and residuals

The selection of materials for sterile medical packaging must also be comprehensively evaluated in relation to the medical devices contained within. ISO 11607-1 summarizes these requirements into the following five characteristics:

1. Microbial Barrier Properties

Packaging materials must be capable of acting as a barrier against microorganisms to maintain the sterility of the medical device.

2. Biocompatibility and Toxicological Properties

Since packaging materials directly or indirectly come into contact with medical devices—and medical devices in turn may come into direct or indirect contact with the human body—biocompatibility must be evaluated to ensure safety for human contact and use.

3. Physical and Chemical Performance Requirements

Materials must meet minimum physical properties such as tensile strength, thickness variation, and tear resistance. They should also meet chemical property specifications, such as pH value and the content of chlorine and sulfur, to ensure no adverse reactions occur with the medical device.

4. Adaptability to Forming and Sealing Processes

Materials must be suitable for sealing or closure requirements, such as seal width and strength, seal integrity, and whether delamination or paper fiber residue occurs during opening.

5. Compatibility with Intended Sterilization Processes

Materials should possess good permeability to air and sterilizing agents to achieve sterilization conditions, and must allow for easy release of the sterilizing agents post-sterilization.

Medical packaging companies should adhere to the ISO 11607-1 requirements to develop and design high-standard medical products. This ensures that sterile packaging systems can maintain their performance and quality up to the point of use, meeting the strict infection control demands of medical environments.

JJR Laboratory in China offers medical device packaging validation and accelerated aging tests in accordance with ISO 11607-1. Feel free to contact us for more information.