Introduction

The packaging of terminally sterilized medical devices plays a critical role in maintaining sterility until the point of use. 

ISO 11607-1, titled "Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile 

barrier systems, and packaging systems," provides comprehensive guidelines to ensure the safety and efficacy of

 medical device packaging. This international standard is essential for manufacturers, regulatory bodies, and healthcare 

providers to guarantee that sterile barrier systems (SBS) maintain integrity throughout distribution and storage.

Scope of ISO 11607-1

ISO 11607-1 specifies the requirements for materials, sterile barrier systems, and packaging systems used for medical 

devices that undergo terminal sterilization. The standard covers:

Material Requirements – Ensures compatibility with sterilization methods (e.g., steam, ethylene oxide, gamma radiation).

Sterile Barrier System (SBS) Design – Defines the minimum criteria for maintaining sterility.

Packaging System Performance – Evaluates durability, seal strength, and microbial barrier properties.

Key Requirements of ISO 11607-1

1. Material Selection and Compatibility

Packaging materials must:

Be compatible with the intended sterilization method.

Maintain integrity after exposure to sterilization conditions (e.g., heat, moisture, radiation).

Not release harmful substances that could compromise patient safety.

2. Sterile Barrier System (SBS) Requirements

The SBS must:

Provide an effective microbial barrier to prevent contamination.

Maintain seal integrity under expected handling and transportation conditions.

Allow for aseptic presentation (easy opening without compromising sterility).

3. Packaging System Validation

Manufacturers must validate packaging systems through:

Physical Testing – Seal strength, burst resistance, and tensile testing.

Testing instrument：LT-02P Leak Tester

ETT-A Multipurpose Tester

Microbiological Testing – Assessing microbial barrier properties.

Testing instrument：LT-PNP Positive &Negative Pressure Sealing Tester

Aging Studies – Evaluating shelf-life stability under real-world conditions.

4. Labeling and Documentation

Packaging must include:

Sterilization method compatibility.

Expiration date based on validated stability studies.

Instructions for use and handling precautions.

Importance of Compliance with ISO 11607-1

Adherence to ISO 11607-1 ensures:

Patient Safety – Minimizes infection risks by maintaining sterility.

Regulatory Compliance – Meets FDA, EU MDR, and other global regulatory requirements.

Supply Chain Reliability – Reduces packaging failures during transportation and storage.

Conclusion

ISO 11607-1 is a critical standard for the medical device industry, ensuring that sterile barrier systems effectively 

protect terminally sterilized devices. By following its requirements, manufacturers can enhance product safety, 

meet regulatory expectations, and improve overall healthcare outcomes. Continuous advancements in packaging

technology further reinforce the importance of compliance with this essential standard.

For manufacturers and stakeholders, staying updated with revisions and best practices in ISO 11607-1 is key to 

maintaining excellence in medical device packaging.