ISO 11607-1:2019

What ISO 11607 means for medical device packaging

ISO 11607 is the international standard for packaging terminally sterilized medical devices. It defines how packaging systems must be designed, validated, and maintained so that sterility is preserved from sterilization through transport, storage, and point of use.

It ensures patient safety, regulatory compliance, and consistent packaging quality across manufacturers and supply chains.

Standardized approach vs inconsistent packaging quality

1. Before ISO 11607: packaging materials, sealing processes, and validation methods varied widely, creating a high risk of barrier failures and non-compliance.
2. With ISO 11607-1 and ISO 11607-2: sterile barrier systems, packaging materials, sealing processes, and validation activities follow a harmonized, globally accepted framework.

Video credit: Nelson Labs on YouTube.

Core building blocks of ISO 11607

1. Packaging system design: definition of the sterile barrier system (SBS) and protective packaging that must withstand sterilization, handling, transport, and storage.
2. Material requirements: packaging materials must provide an effective microbial barrier, be compatible with the chosen sterilization method, and remain stable over the intended shelf life.
3. Seal quality and integrity: sealing processes must be controlled and validated to achieve consistent seal strength and integrity.
4. Performance testing: burst, peel, leak, and dye penetration tests verify the strength and integrity of the sterile barrier.
5. Distribution and transport simulation: vibration, drop, compression, and climatic tests simulate shipping and handling stresses.
6. Process validation (ISO 11607-2): installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for forming, sealing, and assembly processes.
7. Documentation and traceability: procedures, records, and change control required to demonstrate ongoing compliance.

High-value use cases of ISO 11607

1. Medical device manufacturing: pouches, trays, and system packaging for implants, instruments, and disposables.
2. Hospital sterilization departments: sterile packaging and reprocessing of reusable devices.
3. Pharmaceutical and combination products: device–drug systems requiring validated sterile packaging.
4. OEM and contract manufacturers: standardized validation and documentation for global customers.
5. Long-distance distribution: packaging systems that must withstand international shipping and storage conditions.

Video credit: Westpak, Inc. on YouTube.

Integration with related standards

1. Sterilization standards: works alongside standards for ethylene oxide, steam, radiation, and other sterilization methods.
2. Test method standards: relies on specific ASTM and ISO test methods for seal strength, integrity, and distribution simulation.
3. Quality management: complements ISO 13485 quality systems for medical device manufacturers.
4. Regional requirements: supports compliance with EU MDR, U.S. FDA, and other global regulatory frameworks.

How to choose the right packaging system under ISO 11607

1. Define the device, sterilization method, and intended shelf life.
2. Select packaging materials that are compatible with sterilization and provide an effective microbial and physical barrier.
3. Design an SBS plus protective packaging that can withstand handling, transport, and storage.
4. Develop sealing processes and parameters that can be validated and controlled in production.
5. Plan performance and distribution testing, including worst-case configurations and aging if shelf life is claimed.

Video credit: Quality HUB India on YouTube.

Deployment timeline and cost benchmarks

1. Week 1: define packaging requirements, risk analysis, and sterilization methods.
2. Weeks 2–4: select and prototype materials, design the SBS and protective packaging, and conduct initial seal and integrity tests.
3. Weeks 5–8: perform full IQ/OQ/PQ for sealing and packaging processes.
4. Weeks 8–16: complete transport simulation, integrity testing, and accelerated or real-time aging studies if shelf life is required.
5. Ongoing: maintain change control, periodic re-validation, and continuous monitoring of packaging performance.

Video credit: Westpak, Inc. on YouTube.

Common pitfalls and how to avoid them

1. Weak or inconsistent seals: optimize sealing parameters and verify with routine seal strength and integrity testing.
2. Incompatible materials and sterilization: verify that materials do not degrade, delaminate, or lose barrier properties during sterilization.
3. Skipping distribution or aging tests: always validate that packaging maintains integrity through shipping and over the claimed shelf life.
4. Poor documentation: maintain clear records for IQ/OQ/PQ, test results, deviations, and changes.
5. Underestimating worst-case configurations: include maximum load, largest/smallest packs, and most challenging layouts in validation.

Case study: defect rate reduced by 30%

A medical device manufacturer aligned its packaging development and validation fully with ISO 11607.

1. Redesigned pouches and trays to better protect sterile barriers during shipping.
2. Validated sealing parameters and introduced routine seal integrity checks.
3. Result: leaker and damaged-package complaints fell by about 30%, and regulatory submissions moved more smoothly due to robust validation files.

Next steps and additional resources

1. Obtain ISO 11607-1 and ISO 11607-2 for your packaging and quality teams.
2. Map your current packaging processes against the standard and identify gaps.
3. Plan or update your packaging validation master plan, including test methods and sample sizes.
4. Train cross-functional teams (R&D, quality, manufacturing, and regulatory) on ISO 11607 expectations.

Frequently Asked Questions

1. What does ISO 11607 cover?
It covers requirements and validation for packaging systems that enclose terminally sterilized medical devices, ensuring sterility is maintained until point of use.

2. Why is packaging validation required?
Validation proves that the packaging system and sealing processes consistently produce sterile, intact packages under real-world conditions.

3. What tests are typically used?
Common tests include seal strength, burst, peel, dye penetration, bubble leak, distribution simulation, and aging studies.

4. How does ISO 11607 relate to ISO 13485?
ISO 11607 provides detailed packaging requirements that fit within the broader quality management framework of ISO 13485.

5. Where can I access ISO 11607?
Through national standards bodies, ISO, or a standards subscription platform such as BSB Edge.

Need ISO 11607-compliant packaging for your devices?

Start a BSB Edge subscription today and access ISO 11607, related test standards, and sterilization standards in one place so your team can design, validate, and maintain robust sterile packaging systems.