A single compromised seal on a sterile surgical kit can mean the difference between a routine procedure and a hospital-acquired infection. For quality assurance managers at medical device companies, that reality shapes every decision about packaging validation. ISO 11607 exists because the stakes are that high, and because regulators learned decades ago that sterile packaging failures don’t announce themselves until patients are harmed.
The standard governs how terminally sterilized medical devices get packaged, tested, and validated before reaching healthcare providers. If your company manufactures surgical instruments, implants, wound care products, or any device that must remain sterile until the moment of use, ISO 11607 compliance isn’t optional. It’s the baseline expectation from the FDA, European regulators under the EU MDR, and every hospital procurement team evaluating your products.
This guide breaks down what the standard actually requires in plain terms, explains the testing methods that support compliance, and walks through the mistakes that cause companies to fail audits. Whether you’re launching a new sterile device or reevaluating an existing packaging system, understanding ISO 11607 gives you the foundation to protect both patients and your company’s reputation.
What Is ISO 11607?
ISO 11607 is the international standard that specifies requirements for packaging systems used with terminally sterilized medical devices. The term “terminally sterilized” refers to devices that undergo sterilization while already sealed in their final packaging, as opposed to aseptic processing where components are sterilized separately and assembled in a clean environment.
The standard answers a fundamental question: how do you prove that packaging will keep a medical device sterile from the moment it leaves the sterilization chamber until a clinician opens it months or years later?
Published by the International Organization for Standardization, the current version dates to 2019. ISO 11607-1 received Amendment 1 in 2023 for further EU MDR alignment, while ISO 11607-2 was reviewed and confirmed current in 2024. The FDA recognizes ISO 11607 as a consensus standard, meaning manufacturers can use conformance to demonstrate they meet relevant regulatory requirements. In Europe, the standard is harmonized under the Medical Device Regulation, making it effectively mandatory for market access.
ISO 11607 applies to medical device manufacturers, healthcare facilities that repackage or sterilize devices, and any organization involved in creating sterile barrier systems. The requirements cover everything from raw material selection through process validation, with the goal of ensuring packaging performs its protective function throughout the device’s claimed shelf life.
The standard uses “shall” to indicate mandatory requirements and “should” to indicate recommendations. There are over 115 “shall” statements across both parts of the standard, and auditors will verify compliance with each one relevant to your packaging system.
ISO 11607-1 vs ISO 11607-2: What Each Part Covers
The ISO 11607 standard splits into two distinct parts that address different phases of the packaging lifecycle. Understanding this division helps you assign responsibilities correctly and ensures nothing falls through the cracks during validation.
Part 1 covers requirements for materials, sterile barrier systems, and packaging systems. Think of it as the design and testing phase. This section specifies what your packaging must be able to do: maintain a microbial barrier, allow sterilization, withstand distribution hazards, and permit aseptic presentation when opened. Part 1 also lists acceptable test methods for verifying these capabilities and requires manufacturers to demonstrate packaging performance through documented evidence.
Key requirements under Part 1 include microbial barrier testing, seal strength validation, compatibility with sterilization processes, and stability testing to support shelf-life claims. The 2019 revision added explicit requirements for usability evaluation, meaning you must demonstrate that end users can open the package and present the device without compromising sterility. New annexes also provide guidance on environmental considerations and differentiating sterile barrier systems from protective packaging, addressing a common source of confusion during audits.
Part 2 focuses on validation requirements for forming, sealing, and assembly processes. This section addresses how you manufacture the packaging consistently. Once you’ve designed a sterile barrier system that meets Part 1 requirements, Part 2 ensures your production processes can replicate that performance day after day, batch after batch.
Process validation under Part 2 follows the standard IQ/OQ/PQ framework: Installation Qualification confirms equipment is properly installed, Operational Qualification verifies the equipment operates within specified parameters, and Performance Qualification demonstrates the process produces conforming product under actual production conditions.
| Aspect | ISO 11607-1 | ISO 11607-2 |
| Focus | Design and testing | Process validation |
| Scope | Materials, sterile barrier systems, packaging systems | Forming, sealing, assembly |
| Key Activities | Material qualification, package testing, shelf-life studies | Equipment qualification, process parameters, production consistency |
| Output | Documented evidence of package performance | Validated manufacturing processes |
| Who’s Responsible | Package design engineers, testing labs | Manufacturing engineers, quality teams |
Both parts work together. You cannot validate a sealing process (Part 2) without first establishing the seal strength requirements your process must achieve (Part 1). Similarly, a perfectly designed package means nothing if your production line can’t form and seal it consistently.
Key Requirements for Sterile Barrier System Validation
Validating a sterile barrier system under ISO 11607 requires documented evidence across multiple performance categories. The standard doesn’t prescribe exact pass/fail criteria for most tests because acceptable limits depend on your specific device, materials, and distribution conditions. Your job is to establish specifications, justify them scientifically, and prove your packaging meets them.
Microbial Barrier Properties form the foundation of sterile barrier system performance. For non-porous materials like films and foils, you must demonstrate the material prevents microbial penetration. For porous materials like Tyvek or medical-grade paper, testing confirms the material filters microorganisms while allowing sterilant penetration. Standard test methods include ASTM F1608 for microbial ranking and various bacterial filtration efficiency tests.
Seal Integrity proves your packaging has no holes, channels, or weak points that could allow contamination. This isn’t just about seal strength, its about verifying the entire sterile barrier system is intact. Methods include bubble leak testing per ASTM F2096 or ASTM D3078, dye penetration tests, and visual inspection under magnification. Seal integrity testing applies to 100% of production or uses validated sampling plans with statistical justification.
Seal Strength measures the force required to separate sealed materials and indicates process consistency. Testing per ASTM F88 provides quantitative data on seal performance. While seal strength doesn’t directly measure package integrity, tracking seal strength over time helps detect process drift before it creates defects.
Package Integrity After Distribution requires testing that simulates the hazards your packaging will encounter during shipping and storage. ASTM D4169 and ISTA test protocols subject packages to drops, vibrations, compression, and atmospheric pressure changes. Your packaging must maintain sterile barrier integrity after completing these simulations.
Stability and Shelf Life validation demonstrates packaging performance over time. Accelerated aging studies per ASTM F1980 use elevated temperatures to simulate years of storage in compressed timeframes. Real-time aging studies, where packages sit under normal storage conditions for the actual claimed shelf life, provide the definitive evidence. Most regulatory strategies use accelerated aging to support initial market launch, followed by real-time data to confirm results.
Aseptic Presentation testing is a 2019 addition that many companies overlook. You must demonstrate that end users can open the package and remove the device without touching sterile surfaces or allowing contamination. This typically involves observational studies with representative users like surgical nurses or technicians, documented feedback, and sometimes design modifications based on findings.
The validation process generates substantial documentation. You’ll need protocols that define test methods, acceptance criteria, and sampling plans. You’ll need reports showing actual results compared against specifications. And you’ll need traceability connecting raw materials through finished packages to specific test results. Auditors will follow these documentation trails, so gaps create findings.
Testing Methods That Support ISO 11607 Compliance
ISO 11607 references Annex B, which lists over 100 test methods from organizations including ASTM, ISO, CEN, and TAPPI. You don’t need to run all of them, but you do need to select appropriate methods for your packaging system and justify your choices.
ASTM F88 measures seal strength for flexible barrier materials. The test uses a tensile tester to pull apart a cut strip of sealed material at a controlled rate, typically 200-300 mm per minute. Results include maximum seal strength and average seal strength, plus documentation of how the seal failed. A “clean peel” where materials separate at the seal interface is generally preferred over material tears or delamination.
ASTM F2096 detects gross leaks in packaging through internal pressurization. The method submerges a package in water, introduces air pressure through a needle, and observes for bubbles escaping from the sterile barrier system. A steady stream of bubbles indicates a breach. Sensitivity reaches approximately 250 microns for detecting defects. This test works for both porous materials like Tyvek and non-porous films. FlexPak’s Internal Pressurization Assembly (FPIPA) performs ASTM F2096 testing with a transparent acrylic chamber that allows 360-degree observation without rotating the package.
ASTM D3078 is the bubble emission test for flexible packages. Similar in principle to F2096, this method places packages in a vacuum chamber filled with water. The vacuum expands any air inside the package, and bubbles indicate leak locations. Detection sensitivity also reaches 250 microns. This test has been a workhorse for package integrity verification across medical device, pharmaceutical, and food industries for decades.
ASTM F1140 and ASTM F2054 cover burst testing, which applies increasing internal pressure until the package fails. Burst testing indicates the ultimate strength of seals and materials but doesn’t directly measure integrity at normal conditions.
Dye Penetration Testing uses colored solutions to reveal leak paths too small for bubble testing to detect. The package is exposed to dye under pressure or vacuum, then examined for dye ingress. While more sensitive than bubble testing, dye tests are destructive and time-consuming, making them better suited for validation studies than routine quality control.
For pharmaceutical applications subject to USP <1207>, container closure integrity testing may require deterministic methods like helium leak detection or laser headspace analysis. These methods detect smaller defects than bubble testing, down to 50 microns or less with some technologies. USP guidance increasingly favors deterministic methods over probabilistic approaches like dye penetration.
Choosing the right test method depends on your package format, materials, and acceptable quality levels. Pouch packages often use a combination of seal strength testing and bubble leak testing. Rigid tray systems may add burst testing and dye penetration. The key is documenting your rationale and demonstrating the selected methods have appropriate sensitivity for the defects you need to detect.
Common ISO 11607 Compliance Mistakes to Avoid
After working with hundreds of medical device companies on packaging validation, certain failure patterns emerge repeatedly. These mistakes don’t stem from ignorance of the standard but from underestimating specific requirements or misallocating resources during the validation process.
Confusing sterile barrier systems with protective packaging creates problems during audits. The sterile barrier system is the minimum packaging that maintains the microbial barrier: typically the sealed pouch or tray that directly contacts the device. Protective packaging, like cartons and shippers, shields the sterile barrier system from damage but isn’t validated to maintain sterility. Companies sometimes test only the outer packaging or fail to clearly label which layer constitutes the actual sterile barrier. The 2019 revision added guidance specifically addressing this confusion.
Inadequate distribution simulation testing causes more validation failures than any other single issue. Industry data suggests over one-third of package validations fail at the transit testing stage. Companies underestimate the stresses of air freight, the vibration profiles of truck transport, or the pressure changes when shipments cross mountain passes. Understanding your actual distribution routes and selecting appropriate ISTA or ASTM D4169 test profiles prevents expensive surprises.
Skipping usability evaluation for aseptic presentation increasingly triggers regulatory findings. The 2019 revision made this explicit: you must demonstrate that healthcare workers can open your package and present the device without contamination risk. Observational studies with representative users don’t require elaborate clinical trials, but they do require documentation. Most companies still haven’t incorporated this testing into their validation protocols.
Treating stability testing as an afterthought extends timelines and creates gaps. Accelerated aging must start early enough that you have results before planned market launch. Real-time aging must continue for the full claimed shelf life. Companies that don’t plan these studies into their development timeline face choices between delaying launch or launching with limited shelf-life claims.
Insufficient documentation of sampling rationale raises auditor questions even when test results look good. ISO 11607 requires statistically valid sampling, which means you need documented justification for sample sizes based on confidence levels, reliability targets, and attribute or variable data type. Simply testing five samples because that’s what you’ve always done won’t satisfy a rigorous auditor.
Not revalidating after changes to materials, equipment, or processes is a compliance gap hiding in plain sight. ISO 11607-2 requires documented evaluation of any change that could affect package quality. A new film supplier, a sealing equipment adjustment, even a different shift schedule could trigger revalidation requirements. Companies without robust change control procedures accumulate compliance debt until an audit uncovers it.
Avoiding these mistakes requires cross-functional awareness. Package engineers understand material science, but may not appreciate regulatory documentation requirements. Quality teams know documentation, but may not grasp which process changes actually affect seal integrity. Building a validation approach that bridges these perspectives prevents the most common failures.
How to Prepare for an ISO 11607 Audit
Audit preparation begins long before an auditor arrives. The documentation you create during design and validation forms the evidence base auditors will examine. If you treat documentation as a post-hoc exercise, gaps and inconsistencies will multiply.
Start with your Design History File and verify it contains complete records of packaging development decisions. Auditors trace requirements from user needs through design inputs, design outputs, verification, and validation. Missing links in that chain generate findings. Your DHF should show how you selected materials, how you established seal parameters, how you determined which tests to run, and how results supported your decisions.
Compile your validation master plan and protocols into an organized package. Each validation activity, whether IQ, OQ, PQ, or specific performance tests, should have a protocol defining what you’ll do, acceptance criteria, and sampling approach. Executed protocols with actual results, signed and dated, demonstrate you followed the plan. Deviations should be documented with justification for why they don’t affect validity.
Assemble material specifications and supplier qualifications. ISO 11607 requires traceability of materials and evidence that suppliers consistently provide conforming product. Certificates of analysis, incoming inspection records, and supplier audit reports all support this requirement. If you use preformed sterile barrier systems like pouches from a supplier, you need evidence the supplier validated their product per ISO 11607.
Review your process validation documentation for completeness. Sealing equipment should have documented IQ showing proper installation, OQ showing it operates across the qualified range, and PQ demonstrating consistent production output. Process parameters like temperature, pressure, and dwell time should be specified with tolerances, and records should show actual values stay within tolerance during production.
Prepare your stability data, both accelerated and real-time. Auditors often examine whether your shelf-life claims have adequate support. If you’re relying on accelerated aging alone, have the protocol and results ready along with the temperature-time calculations per ASTM F1980. If real-time data exists, show the ongoing monitoring results.
Organize change control records showing how you evaluate and document changes. Auditors frequently sample change records to verify proper evaluation occurred. A change that should have triggered revalidation but didn’t creates a significant finding.
Brief your team on common auditor questions. Production operators should understand why they follow specific procedures. Quality technicians should be able to explain test methods and acceptance criteria. Engineers should articulate validation rationale. When auditors interview staff and get confident, consistent answers, it reinforces that your system works.
During the audit itself, respond to requests promptly and directly. If you don’t have a document, say so rather than stalling. If you realize a gap exists, acknowledge it and explain how you’ll address it. Auditors distinguish between companies that have genuine systems with minor gaps and companies that have paper systems without substance.
Your Next Step Toward ISO 11607 Compliance
ISO 11607 compliance protects patients by ensuring medical device packaging maintains sterility from manufacturing through end use. The standard demands rigorous attention to materials, design, testing, and process validation, with documentation that proves every requirement was met.
The testing methods that support compliance, including seal strength testing per ASTM F88 and integrity testing per ASTM F2096 and ASTM D3078, provide the quantitative evidence auditors and regulators require. Getting these tests right means having the proper equipment, validated procedures, and trained personnel to generate defensible data.
If your quality team needs support establishing package integrity testing capabilities, FlexPak offers leak detection equipment designed specifically for ISO 11607 compliance. Our Internal Pressurization Assembly enables ASTM F2096 testing with 250 micron sensitivity, and our bubble emission systems support ASTM D3078 testing across medical, pharmaceutical, and food packaging applications. With over 25 years of experience in package integrity testing, we help companies build testing programs that satisfy auditors and protect patients.
Ready to strengthen your ISO 11607 compliance testing? Contact FlexPak for guidance on selecting the right equipment for your packaging formats and testing requirements. Our team responds within 24 hours to help you find the solution that fits your validation needs.
Frequently Asked Questions
What is ISO 11607? ISO 11607 is the international standard specifying requirements for packaging systems used with terminally sterilized medical devices. It covers material selection, sterile barrier system design, performance testing, and process validation to ensure packaging maintains device sterility until point of use.
Is ISO 11607 required by the FDA? The FDA recognizes ISO 11607 as a consensus standard. While not explicitly mandated by regulation, conformance to ISO 11607 is the expected method for demonstrating sterile medical device packaging meets safety and performance requirements. Most FDA submissions reference ISO 11607 compliance.
What is the difference between ISO 11607-1 and ISO 11607-2? ISO 11607-1 addresses packaging design, materials, and testing requirements. It specifies what the packaging must do. ISO 11607-2 covers validation of manufacturing processes for forming, sealing, and assembly. It specifies how to prove production consistently meets design requirements.
What tests are required for ISO 11607 compliance? Required tests depend on your specific packaging system but typically include seal strength testing (ASTM F88), package integrity testing (ASTM F2096, ASTM D3078, or equivalent), distribution simulation testing (ASTM D4169 or ISTA protocols), and stability testing (accelerated aging per ASTM F1980 plus real-time aging).
How often must ISO 11607 validation be repeated? Initial validation establishes baseline compliance. Revalidation is required when changes occur to materials, equipment, processes, or suppliers that could affect package quality. Ongoing process monitoring should detect drift before revalidation becomes necessary. The standard also requires periodic review of validation status.