Resources
ISO 11607, with the arithmetic shown and the source named.
Written for the engineer who already knows the terms and has to defend a decision to a reviewer: a sampling rationale, an aging basis, a declaration of conformity with a date on it. These are the pages we went looking for and could not find, so we wrote them.
In short
Four ISO 11607 resources, free to read in full
Probity Sciences publishes four pieces on ISO 11607 packaging validation: the December 2026 FDA recognition transition, an ASTM F1980 accelerated aging calculator with the arithmetic written out, sample size justification worked through in public, and a glossary of the terms this work uses precisely. Every page is free to read in full, and nothing has to be filled in first.
Using these pages
Written to be read cold, and forwarded.
The whole of every page is on the page. Read it, print it, quote it in an internal document, or send the link to whoever else has to look at it. Nothing has to be filled in first and nothing needs permission or signing.
Often the person who reads a page is not the person who signs it. So each one is built to survive being pasted into an email whole and read cold: the reasoning runs top to bottom, the arithmetic is shown rather than asserted, and the source of every claim travels with the sentence that makes it.
Where to start
Five questions your file turns on, and where each is answered.
These are the five questions the work turns on, and four of them are documented verbatim on the open quality forums. You get the short answer to each one here. The long answer is the page linked beside it, and where that page is still being written, the link tells you exactly what it gives you instead.
- 01Does ISO 11607 apply to us?
If your device is terminally sterilized and its packaging has to maintain sterility until the point of use, yes.
The title of the standard is most of the answer: "Packaging for terminally sterilized medical devices". Where the device is not terminally sterilized, the packaging can be validated against requirements you state instead, and the standard sits outside the question. Conformity to a recognized consensus standard is voluntary in any case. What a reviewer examines is whether the evidence supports the claim being made, and a declaration of conformity is one route to that rather than the only one.
Until the applicability page lands, the link below gives you the vocabulary the question turns on rather than the answer itself. For your device, thirty minutes on a call settles it.
- 02How many samples?
There is no number in the standard, and no sample size is correct on its own. What is accepted is a stated basis.
The basis is the risk being protected against, whether the data is attribute or variable, the confidence and reliability being claimed, and the arithmetic that connects those to a number. The number without the reasoning is the finding. A poster on the Elsmar Cove quality forum, writing from the regulator side, put it as plainly as it can be put: "If I see a company that has a clear rationale regarding sampling size, I don't look too much further." That is a forum post rather than guidance, and it is quoted here as one practitioner's view.
- 03In what sequence?
No order is mandated. Performance and stability are separate branches off the sterilized product, not a chain.
ASTM F1980 section 1.5 puts distribution, handling and shipping events outside the scope of the aging guide, so the two branches are asking different questions of the same package. Whether to run the branches separately or combine them as a worst case is a risk-based decision, and combining them costs you the ability to tell an event-related failure from a time-related one. Any order can be right for the right reason, which is why the artifact you defend is the rationale rather than the sequence. The competence is choosing which branches the product's risk profile justifies, and writing down why.
- 04Who validates the test method?
The laboratory performing the test.
The validation record normally sits with the laboratory performing the test, because publication of a method by a standards body does not by itself make it validated there: a test report naming a method is not on its own evidence that the method was validated for your material and your seal configuration. So ask for the test method validation position on every method before samples ship, and put the answer in the file: that question is cheap at quotation and expensive in an Additional Information response.
- 05What goes in the submission?
A reasoned case, with the test reports as its evidence. Not the test reports on their own.
The packaging system described in the terms the standard uses. The standards and editions declared with their FDA recognition numbers. The linkage from packaging decisions to the risk management file that Amendment 1:2023 asks for. The sampling rationale. Protocols whose acceptance criteria were set before the results existed. The test method validation position. The aging basis with its pull points. The distribution profile, and why it matches how the product actually ships. Then a conclusion that returns to the claim it started from. Our reading, labeled as ours: a packaging section is questioned more often on what fails to join up than on a test that is missing.
Published
The four pieces, and what each one gives you.
Four pieces at launch. Each exists because the question behind it is documented on the open quality forums, where the answers easiest to find are written by whoever sells the test.
- R-01The 2026 transition: 14-530, 14-594 and your declaration of conformity
Guide
What actually changes for a premarket submission made after 20 December 2026, and the much longer list of things that carry on exactly as they are.
- What an FDA recognition number is, and what a declaration of conformity is actually pointing at when it cites one.
- Recognition 14-530 covers ISO 11607-1:2019 without Amendment 1. Declarations to it are accepted in premarket submissions until 20 December 2026. Recognition 14-594 covers the amended edition.
- Why this is a documentation gap rather than a testing gap: Amendment 1:2023 applies a defined risk management process to packaging, and our reading, labeled as ours, is that a packaging file assembled before 2024 had no particular reason to show that linkage, because the edition it was written against did not ask for it.
- How far the date actually reaches, stated precisely: it lands on premarket submissions filed after 20 December 2026, and devices already on the market sit outside it, which is the opposite of what the word recall implies.
- How to verify the whole thing yourself in the FDA Recognized Consensus Standards database, with the search that gets you there.
Every date in the guide comes from an FDA recognition entry read at source and checkable from the page in a couple of minutes, for Part 1 and Part 2 alike. What those entries settle is which edition is recognized and until when. What they settle nothing about is what either part of the standard requires, and the guide says so rather than filling the gap.
Anyone whose premarket submission will be filed after 20 December 2026, and anyone who has been told there is a December cliff for a product already on the market. The guide shows where that idea comes from and what the record says instead.
- R-02ASTM F1980 accelerated aging calculator
Calculator
Enter the shelf life you are claiming, the aging temperature, the ambient temperature you are aging against and the Q10 you are prepared to defend. It returns the aging duration and the pull point schedule.
- The Arrhenius arithmetic written out in text, not hidden in the script, so you can check it and so it can be read by anything that reads pages.
- A worked example carried all the way through: a three year claim, aging at 60 degrees Celsius against a 23 degree Celsius ambient, with a Q10 of 2. The acceleration factor is 12.996, 1095 days becomes 84.26, and the schedule is 85 days. It rounds up because rounding down under-ages the samples.
- A printable protocol appendix with the inputs, the working and the pull point dates, which is the part that has to survive into your file.
- Why the Q10 you enter is, on our reading, the assumption on the page most exposed to question, and what documenting it looks like.
The calculator does the arithmetic and shows it. The Q10 is yours to defend for your materials, and the page shows what defending it looks like in writing. Real-time aging runs alongside, confirms the claim later and keeps running after the submission has gone in, which is what the accelerated schedule buys you: a filing date that does not wait three years. Aging duration itself is set by physics, so anyone quoting a shorter oven schedule for the same claim has changed an assumption. Ask which one.
Whoever has to turn a shelf life claim into an oven schedule and a set of pull dates that line up with a submission date.
- R-03Sample size justification
Worked example
One of the most asked and least answered questions on the open quality forums, worked through in public: not what number to use, but how to arrive at one you would defend in writing.
- Why the standard gives no number, and why looking for one based on batch size is a search that never terminates.
- Attribute data and variable data, and how much the choice changes what you have to run.
- Where confidence and reliability claims come from, what they cost in samples, and how to state them so the arithmetic is reproducible by the person reading it.
- Why a small sample size can be perfectly defensible with a written basis, and why a large one is still a finding without it.
- What to do when the laboratory's justification for a number is that it is common practice, which is the answer one poster on Elsmar Cove reported getting.
The page gives you the route to a number you would defend rather than a number to copy. The rationale is the deliverable, it has to be yours and about your device, and a rationale lifted from a stranger's website is likely to read to a reviewer the same way as no rationale at all.
The engineer who has to put a number in a protocol this week and knows it will be the first thing questioned.
- R-04Glossary
Reference
The terms this work uses precisely, with the distinction each one carries and why it matters in a submission.
- Sterile barrier system, packaging system and protective packaging: three different things, and which requirements attach to which.
- Terminally sterilized, aseptic presentation, seal channel and pull point, in the sense the standard uses them rather than the sense a supplier catalog uses them.
- Seal integrity and package integrity, which are not the same claim and are not shown by the same test.
- Real time aging, accelerated aging, design history file, Additional Information letter and notified body, defined for the person who has to write them into a document.
Every entry says why the distinction matters, not just what the word means. A document that uses Part 1 where it means Part 2, or that calls a sterile barrier system "the packaging", is likely to tell a reviewer something about who wrote it.
Anyone writing the packaging section for the first time, and anyone reviewing one written by somebody else.
One more page
Where the testing physically happens.
If you searched for package testing near Seattle, there is a page that answers it straight. We work nationally and deliver remotely, and your samples go to the laboratory that fits the method, the accreditation scope and the schedule, wherever that laboratory is, because on a deadline chamber availability matters more than travel.
Package testing near SeattleAlso on the site
A readiness check you can run now, and a note for funded teams.
- ISO 11607 packaging readiness assessment
Tool
Fifteen questions across six areas. In about four minutes you see how much of your packaging evidence is written down, how much is still in people's heads, and where the open items are.
- Using SBIR or STTR funds for packaging validation
Guide
How packaging validation gets funded from an SBIR or STTR award, including the TABA route, what the two fees look like against the budget, and how your application names the provider you choose.
How these are written
Written to be checked, not skimmed.
- Named byline and a date
Every resource page linked from this hub says who wrote it and when. The author is the specialist who did the work.
- Cited to the clause
Where a claim rests on a standard, the clause is named and its wording is quoted. Where it rests on a regulator's record, the record is named so you can pull it up yourself. Where a statement comes from a vendor or a practitioner forum rather than a regulator, the page says so, and where we have not read the source ourselves we say that too.
- Corrections on the page, with the date
When something published here turns out to be wrong, it is corrected in place, dated and explained. The policy has already been used twice, both on claims we had made in our own internal material. One was a sequencing claim that traced back to a vendor article with no clause behind it and was contradicted by the scope of the aging guide it relied on; it was cut rather than softened. The other traveled in the same sentence, could not be sourced, and was withdrawn rather than kept on the balance of probability. Both are in the corrections log, dated.
- Printable
Each resource page prints with its title, byline, date and URL, so a printed copy still says where it came from.
- Published when finished
Pieces appear when they are done and checked, which is a slower list than a publishing calendar produces and a more useful one. To be told when a specific piece lands, email and ask, and a person will answer.
Next
Bring the question that brought you here.
Thirty minutes, no slides. Bring the device description, the sterilization method and your submission date, and you will leave the call knowing which of the five questions above is actually your problem, what evidence closes it, and roughly what that costs. If your file already covers it, you will hear that plainly, and that is a normal outcome of the call.
Or email directly, and get a personal reply the same business day, from the specialist who would do the work.
Book a 30-minute call