ISO 11607 — Packaging for Terminally Sterilized Medical Devices
The global consensus standard for sterile barrier validation
What It Is
ISO 11607 is the international standard for packaging of terminally sterilized medical devices. It consists of two parts: Part 1 covers requirements for materials, sterile barrier systems, and packaging systems, while Part 2 covers validation requirements for forming, sealing, and assembly processes. Together, they define the framework that medical device manufacturers must follow to demonstrate that their packaging maintains sterile barrier integrity through sterilization, distribution, storage, and use. A typical ISO 11607 validation program references multiple ASTM and ISTA test methods to demonstrate compliance.
When You Need It
You need ISO 11607 validation when launching a new terminally sterilized medical device, when making changes to packaging materials, sealing processes, or sterilization methods, when extending shelf-life claims, when responding to regulatory submissions (510(k), CE marking, MDR), or when your quality system requires periodic revalidation of packaging processes.
What We Do
Boulder Package Testing designs and executes complete ISO 11607-1 and ISO 11607-2 validation programs. We work with your engineering and quality teams to define the validation protocol, then execute the full test battery: package conditioning (ASTM D4332), distribution simulation (ISTA 3A or ASTM D4169), accelerated and real-time aging (ASTM F1980), seal strength (ASTM F88), burst testing (ASTM F1140), dye penetration (ASTM F1929), bubble leak (ASTM F2096), and visual inspection (ASTM F1886). All testing is performed under one chain of custody, one quality system, and — when sterilization is needed — on the same campus as Boulder Sterilization.
Equipment & Methodology
Full suite of package testing equipment for all referenced ASTM and ISTA test methods, housed in our Boulder, Colorado facility.
How It Fits Into ISO 11607
ISO 11607 is the parent standard. All test methods offered by Boulder Package Testing are referenced within ISO 11607 validation programs.
Learn more about ISO 11607 validation programs →Frequently Asked Questions
What is ISO 11607 and what testing does it require?
ISO 11607 is the global consensus validation standard for terminally sterilized medical device packaging. Part 1 covers requirements for materials, sterile barrier systems, and packaging systems. Part 2 covers validation of forming, sealing, and assembly processes. A typical ISO 11607 program includes package conditioning (ASTM D4332), distribution simulation (ASTM D4169 or an ISTA profile such as 3A), accelerated aging (ASTM F1980), seal strength (ASTM F88), visual inspection of seals (ASTM F1886), dye penetration (ASTM F1929), and bubble or gross leak testing (ASTM F2096).
How long does a complete ISO 11607 validation take?
For a standard one-year shelf life claim using ASTM F1980 accelerated aging at 55 degrees C, end-to-end turnaround is typically 8 to 12 weeks. Each additional year of shelf life adds roughly four weeks to the overall project.
Can I use ISO 11607 validation data for FDA and EU submissions?
Yes. ISO 11607 is recognized globally and referenced by FDA guidance documents and the EU Medical Device Regulation (MDR). A well-executed ISO 11607 validation program provides the packaging evidence needed for 510(k), PMA, CE marking, and other regulatory submissions.
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