Comparison · Packaging and distribution · 19 min read
ISTA 2 Series vs 3 Series: What FDA Accepts for Shipping Tests
Both are ISTA transit tests, and both use drops and vibration. But FDA recognizes three procedures from the 3 series and has formally declined to recognize the 2 series procedure 2A. Here's what separates them, why FDA draws the line where it does, and which standard fits which kind of shipment.
ISTA 2 Series
Partial simulation
Basic integrity tests plus at least one simulation element
2A not recognized by FDA
ISTA 3 Series
General simulation
A lab recreation of a defined distribution environment
3A, 3B and 3E recognized by FDA
Why distribution testing matters
A device that leaves the factory in perfect condition still has to survive forklifts, conveyor drops, truck vibration, stacked pallets, cold cargo holds and, for sterile products, all of that without a single breach in the sterile barrier. Distribution testing is how you show it will.
The requirement comes from several directions at once:
- US: under the QMSR, design validation follows ISO 13485 clause 7.3.7, and clause 7.5.11 requires you to protect product from damage during storage, handling and distribution.[1][2]
- EU: MDR Annex I Section 7 requires that transport and storage, including temperature and humidity swings, don't harm a device's characteristics and performance. Section 11.4 requires sterile devices to stay sterile under the transport and storage conditions the manufacturer specifies.[3]
- Sterile packaging: ISO 11607-1 has a dedicated clause on packaging system performance and stability testing, so the sterile barrier has to be shown to survive both distribution and time.[4]
The conditions you test should also match what your label says. The MDR requires the label to show any special storage or handling conditions, so a "store at 2–8 °C" or "keep dry" claim needs distribution and storage evidence behind it.[3] Transport damage is a hazard in its own right too, so the risks belong in your ISO 14971 risk analysis, with the transit test as one of the controls that address them.[5]
None of these names a specific transit test. That choice is yours, and it's where the ISTA 2 versus 3 question comes in.
The ISTA test series on one page
The International Safe Transit Association groups its procedures into numbered series. Each step up the ladder gets closer to real-world distribution.[6]
- 1Non-simulation integrity
Checks whether product and package hold up as a unit, without trying to mimic any real route. Simple and fast. Example: 1A.
- 2Partial simulation
Starts from the 1 Series checks and adds a piece of real-world simulation, for example a temperature and humidity step or a shaped vibration profile. Examples: 2A, 2B, 2C.
- 3General simulation
Recreates in the lab the handling, vibration and climate a package meets on a known type of route, such as parcel, LTL or full truckload. Examples: 3A, 3B, 3E, 3F, 3H.
- 4Enhanced simulation
Custom test plans tailored to your own distribution pattern, using ISTA's library of hazard data. Example: 4AB.
- 6Member performance tests
Written for a specific company's supply chain, such as a retailer or carrier. Examples include Amazon, FedEx and Sam's Club procedures.
- 7Development tests
Tools for package designers, including thermal testing such as 7E. ISTA Standard 20 covers the design and qualification of insulated shipping containers.[7]
2A and 3A compared
The clearest comparison is between the two procedures most device teams consider for individual packages: 2A and 3A.[8][9]
| ISTA 2A | ISTA 3A | |
|---|---|---|
| Type | Partial simulation | General simulation |
| Scope | Individual packaged products up to 150 lb (68 kg) | Individual packages up to 70 kg (150 lb) shipped by parcel carrier, by air or ground |
| Package types | Not broken out | Standard, small, flat and elongated, each with its own sequence |
| Conditioning | Ambient preconditioning, then controlled temperature and humidity (both required) | Ambient preconditioning required; controlled temperature and humidity optional |
| Compression | Yes, a compression test | No separate test; top load is applied during vibration |
| Vibration | Fixed displacement or random, run before and after shock | Random vibration with and without top load, based on parcel delivery profiles; optional vibration under low pressure (simulated altitude), with levels for truck-only or truck-and-air shipment |
| Shock | One of drop, incline impact or horizontal impact; drop height or impact speed varies with weight | Two drop sequences (17 drops for a standard package), plus rotational edge, flat, concentrated or bridge impacts depending on package type |
| Liquids | Not specifically addressed | 8-hour leak test for liquid products |
| Samples | One required; ISTA recommends five or more | One required; two or more for fragile or liquid products; ISTA recommends five or more |
| FDA recognition | Not recognized 2A:2011 is on FDA's list of non-recognized standards | Recognized 3A 2018, recognition number 5-126 |
| Best used for | Early screening and comparing package designs | Design validation evidence for parcel-shipped devices |
The rest of the 3 Series covers other ways goods move. FDA also recognizes 3B (2017 edition, less-than-truckload shipments, number 5-127) and 3E (2017 edition, unitized loads of similar products shipped by full truckload, number 5-128).[10] Other 3 Series procedures, such as 3F (distribution center to retail) and 3H (mechanically handled bulk containers), are not on FDA's list.
What FDA actually says
FDA doesn't leave this to interpretation. Its standards database has a table of standards it reviewed and decided not to recognize, and ISTA 2A:2011 is on it, with a written rationale.[11] The reasoning comes down to three points:
- It's only part of a simulation. FDA treats 2A as a screening test that predicts real-world results less reliably than the 3 Series.
- It misses higher-risk cases. It leaves out checks FDA considers essential for sterile barriers, sensitive electronics, liquids and parts known to be fragile in transit.
- So it can't carry a declaration of conformity. FDA calls the method
not robust enough
to support one.[11]
Only 2A is on the non-recognized list. FDA's rationale itself notes that 2A is one of three tests ISTA offers in the 2 Series, yet 2B (packages over 150 lb) and 2C don't appear in either the recognized or the non-recognized table. That leaves them available only as general use, and FDA's reasoning about partial simulation applies to them just as it does to 2A.[11][10][6]
Recognition is also edition-specific. FDA recognizes ISTA 3A 2018, 3B 2017 and 3E 2017, ASTM D4169-22 and ASTM D7386-16.[10] ASTM has since published D4169-23e1 and D7386-25, and as of November 2026 FDA still lists only the older editions.[13][14] If you test to a newer edition, check the database first; an edition that isn't listed is treated as general use too.
What the EU expects
There is no harmonised transit test standard under the EU MDR. The packaging standards that are harmonised are EN ISO 11607-1 and EN ISO 11607-2 (2020 editions with Amendment 1 of 2023), which cover sterile barrier and packaging systems, including performance testing.[15][4] They don't mandate ISTA or ASTM by name.
In practice, notified bodies look for a distribution simulation that matches how the device actually ships, justified in the technical documentation against Annex I Sections 7 and 11.4. A 3 Series procedure or ASTM D4169 is the usual answer for the same reasons FDA gives, and a partial simulation like 2A will invite the same questions.[3]
Which standard for which job
Pick by how the product really moves, not by habit. Filter by shipping situation, or scan the full list.
Single packages by parcel carrier, up to 70 kg
ISTA 3A FDA 5-126
The common choice for parcel-shipped devices. Fixed sequences by package type.
Read more
What it tests: Parcel handling as a fixed sequence: ambient conditioning (controlled temperature and humidity optional), two rounds of drops (17 in total for a standard package), random vibration with and without a top load, optional vibration under low pressure (simulated altitude) for truck-only or truck-and-air routes, extra impacts for flat and elongated packages, and an 8-hour leak check for liquids.[9]
Use it when: your device ships on its own, or a few to a box, through a parcel network, up to 70 kg.
Watch out for: choosing the right package type, because the sequence changes with it. Base the conditioning on the climates you really ship through, and test the worst-case configuration: heaviest, most fragile, or largest box.
Status: FDA recognized (2018 edition, 5-126). Not harmonised in the EU, so justify the choice in your technical documentation.[10]
Single parcel delivery, up to 68 kg
ASTM D7386 FDA 5-113 (2016 ed.)
ASTM's parcel practice. ASTM D4169 itself points to D7386 for single parcel shipments.[13]
Read more
What it tests: A sequence of hazards representative of single parcel delivery, for shipping units up to 150 lb (68 kg).[14]
Use it when: you prefer an ASTM framework for parcel shipments, or your test lab and customers work in ASTM.
Watch out for: the edition. FDA recognizes D7386-16, while ASTM's current edition is D7386-25. Testing to the 2025 edition counts as general use until FDA recognizes it.[10][14]
Status: FDA recognized (2016 edition, 5-113).
Multi-step or mixed distribution you want to define yourself
ASTM D4169 FDA 14-576 (2022 ed.)
Builds a test from distribution cycles and assurance levels, run in sequence on the same samples.[13]
Read more
What it tests: You pick a distribution cycle, a defined sequence of hazard elements such as handling, vehicle stacking, vibration and low pressure, plus an assurance level that sets how hard each test is. The tests run in order on the same samples.[13]
Use it when: the route is complex or mixed, such as truck, then air, then local delivery, or when you need to tailor test intensity to the product's risk.
Watch out for: justifying the cycle and assurance level from your real distribution. For single parcel shipments, D4169 itself points to D7386. FDA recognizes D4169-22; ASTM's current edition is D4169-23e1.[13][10]
Status: FDA recognized (2022 edition, 14-576).
Palletized, less-than-truckload shipments mixed with other freight
ISTA 3B FDA 5-127
For loads that share a truck with other shippers' goods.
Read more
What it tests: The handling, stacking and vibration a packaged product meets when it shares a truck with other shippers' freight and is rehandled at terminals along the way.
Use it when: palletized or crated equipment, such as instruments and capital equipment, moves less than truckload.
Watch out for: handling impacts at cross-docks, which drive most damage in this mode. Test the shipping configuration you actually use, crate or pallet.
Status: FDA recognized (2017 edition, 5-127).[10]
Full truckloads of unitized, similar products to one destination
ISTA 3E FDA 5-128
Typical for factory to distribution center moves.
Read more
What it tests: Whole unit loads of the same product, typically pallets, against the compression, vibration and handling of full truckload shipment to a single destination.
Use it when: product moves in full truckloads from the factory to a distribution center or distributor.
Watch out for: what happens next. 3E tests the unit load, not single cartons. If cartons later travel on by parcel, test that leg too, with 3A or D7386.
Status: FDA recognized (2017 edition, 5-128).[10]
Extreme heat, cold or humidity during parcel transit
ASTM F2825 FDA 14-513 (2018 ed.)
Climatic stressing of packaging systems for single parcel delivery.
Read more
What it tests: How packaging systems for single parcel delivery cope with climatic extremes of temperature and humidity.
Use it when: you ship into hot or cold regions, by air without climate control, or your adhesives, seals or foams are temperature-sensitive.
Watch out for: its scope. It covers climate only, so pair it with a mechanical test such as 3A or D7386.
Status: FDA recognized (2018 edition, 14-513).[10]
Requirements for sterile barrier and packaging systems
ISO 11607-1 and -2 FDA 14-594, 14-595
Performance and stability testing, plus forming, sealing and assembly validation. Harmonised in the EU.[4][15]
Read more
What it covers: Part 1 sets requirements for materials, sterile barrier systems and packaging systems, including performance testing (surviving distribution) and stability testing (surviving time). Part 2 covers validation of the forming, sealing and assembly processes.[4]
Use it when: your device is terminally sterilized.
Watch out for: what it doesn't do. ISO 11607 says what you must demonstrate, not which transit test to use, so you still pick an ISTA or ASTM method. Part 1 also asks for a usability evaluation of aseptic presentation. ISO/TS 16775, which FDA also recognizes (14-585), is the companion guidance on applying both parts.[16]
Status: FDA recognized (2019 editions with Amendment 1, 14-594 and 14-595). EN ISO 11607-1 and -2 are harmonised under the MDR.[10][15]
Checking the sterile barrier after transit or aging
ASTM F88, F1929, F2096, F2338 FDA recognized
Seal strength, dye penetration, bubble leak and vacuum decay tests. Pick based on package type and the sensitivity you need.
Read more
What they test: F88 measures seal strength, the force needed to peel a seal apart. F1929 uses dye to find channel leaks in the seals of porous packaging. F2096 finds gross leaks by pressurizing the package under water. F2338 detects leaks without destroying the package, using vacuum decay.
Use them when: you need to show the sterile barrier is intact after sterilization, transit and aging.
Watch out for: the difference between strength and integrity. A strong seal can still leak, so most teams use one of each. Validate the method's sensitivity for your package, as ISO 11607-1 requires.[4]
Status: FDA recognized editions: F88/F88M-23 (14-596), F1929-23 (14-600), F2096-11 reapproved 2019 (14-359) and F2338-09 reapproved 2020 (14-282).[10]
Supporting a shelf life claim before real-time data
ASTM F1980 FDA 14-575 (2021 ed.)
Accelerated aging of sterile barrier systems, run alongside real-time aging.
Read more
What it tests: Accelerated aging: storing packages at raised temperature to simulate the passage of time, so you can support a shelf life claim before real-time results are in.
Use it when: you want to launch with a labeled shelf life without waiting years for real-time data.
Watch out for: real time. Run real-time aging in parallel to confirm the accelerated result, and don't pick an aging temperature so high that it changes the materials in ways normal storage never would.
Status: FDA recognized (2021 edition, 14-575).[10]
Temperature-controlled parcel shipments
ISTA 7E and Standard 20 Not FDA recognized
7E provides standard summer and winter temperature profiles for parcel delivery; Standard 20 covers designing and qualifying insulated shipping containers.[7]
Read more
What it covers: 7E provides standard summer and winter temperature profiles for parcel delivery. Standard 20 is a process for designing and qualifying insulated shipping containers that uses the 7E profiles.[7]
Use it when: refrigerated or frozen products, such as IVD reagents, ship by parcel.
Watch out for: the regulatory gap. Neither is FDA-recognized, and Standard 20 was written by pharmaceutical industry experts, though device and IVD teams use it too, so explain why the profiles represent your own lanes. Temperature control doesn't replace a mechanical test.
Status: Not FDA recognized.
Selling through a retailer or marketplace with its own rules
ISTA 6 Series Not FDA recognized
Often a commercial requirement. Use it in addition to, not instead of, your validation method.
Read more
What it covers: Procedures written for a specific company's network, such as Amazon's test for products shipped in their own container, or procedures for FedEx or Sam's Club.[6]
Use it when: a retailer or carrier requires it before it will accept your product.
Watch out for: treating it as validation evidence. It answers a commercial requirement, not a regulatory one.
Status: Not FDA recognized.
Distribution center to retail store on mixed pallets
ISTA 3F Not FDA recognized
Useful for over-the-counter devices sold in stores.
Read more
What it covers: Individual products of 100 lb (45 kg) or less moving on mixed pallets from a distribution center to a retail store.[6]
Use it when: over-the-counter devices, such as thermometers or blood pressure monitors, are sold in stores.
Watch out for: its narrow scope. It covers the distribution-center-to-store leg only.
Status: Not FDA recognized.
Early screening of package concepts
ISTA 1A or 2A Not recommended for validation
Cheap and fast for finding weak designs before you commit to a formal 3 Series or ASTM run.
Read more
What they cover: 1A is a basic integrity test with vibration and drops, and no attempt to mimic a real route. 2A adds conditioning, compression and more realistic vibration.[8]
Use them when: you want to compare package concepts, materials or suppliers quickly and cheaply, or reproduce a field failure.
Watch out for: how you present the results. Keep them in your development records and don't offer them as validation evidence.
Status: 2A is on FDA's list of non-recognized standards; 1A is not recognized.[11]
A custom test plan for an unusual distribution pattern
ISTA 4AB Not FDA recognized
Powerful, but you'll need to justify the distribution pattern and the plan in full.
Read more
What it covers: A custom test built for a distribution pattern you define, using ISTA's library of hazard data.[6]
Use it when: your route is unusual, the equipment is high-value, or standard procedures clearly don't match reality.
Watch out for: the burden of proof. You'll need to show the pattern matches how the product really ships, and justify every test in the plan.
Status: Not FDA recognized.
Building the test plan
Choosing the standard is one decision in a longer chain. Whichever method you pick, the plan around it decides whether the result holds up in a submission or an audit.
- Map how the product really ships.
List every leg from the factory to the point of use: carriers, modes (air means low pressure), hand-offs, the hottest and coldest regions, and the longest storage time. Include returns, service shipments and any distributor who repacks. The map is what justifies your choice of standard, and if it doesn't match reality, neither does the test.
- Define what you're testing and the worst case.
Test the final packaging configuration, built with production materials and processes. Use real product, or a representative substitute with the same mass, centre of gravity and fragile features if the real thing is too costly. Where a family shares packaging, pick the worst case and write down why it covers the rest.
- Set pass criteria before you start.
ISTA and ASTM procedures tell you how to apply the hazards, not what counts as a pass; that's up to you. Define it in three parts. Product: does it work, look right and keep its calibration? Package: what damage is acceptable? Sterile barrier: which integrity and seal tests, and what results? Criteria written after the results are in will not convince a reviewer.
- Justify the sample size.
A procedure's minimum of one sample is a test minimum, not a validation sample size. ISO 13485 asks for statistical techniques with a rationale for sample size in verification and validation plans, and most companies tie the confidence and reliability levels to the risk of the failure the test guards against.[2]
- Put the tests in the right order.
For a terminally sterilized device, a typical sequence runs as below. Each step uses packages that have already been through the steps before it, so the result reflects what a real package experiences.[4]
Validated sealing processISO 11607-2Sterilizationworst-case exposureAgingASTM F1980 + real timeTransit simulationISTA 3 Series or ASTMIntegrity and functionF88, F1929, F2096 or F2338, plus functional checksFor a non-sterile device, the sequence is shorter: conditioning, transit simulation, then functional and visual inspection.
- Record it and keep it current.
The protocol, raw data and report belong in your design and development file, and the transit test should trace back to the risks it controls.[2][5] Treat later changes to packaging, product or distribution as design changes, and decide each time whether the existing evidence still holds.
Common questions
Can we use ISTA 2A at all?
Yes, for development and screening. As validation evidence in an FDA submission, you would have to justify it in full against FDA's written concerns.
Read more
2A is useful wherever speed matters more than prediction: comparing early package concepts, checking a new material or supplier, or quickly reproducing a damage pattern seen in the field.
In a submission it would be general use: you explain why you chose the method and include the underlying data, in practice the full test report.[12] That rationale has to answer FDA's three concerns: partial simulation, gaps for sterile, electronic, liquid and fragile products, and lower predictability.[11] For most devices it is less work to run a recognized method than to argue the case.
If an older product was validated with 2A, plan to move to a recognized method the next time the packaging or distribution changes, and record that decision in the change record.
ISTA 3A or ASTM D4169: which is better?
Neither is better in general, and FDA recognizes both. Pick the one that matches how your product actually ships.
Read more
ISTA 3A is a fixed procedure for parcel shipments: the package type and weight set the sequence and drop heights, so it is quick to plan and easy to compare across products.[9]
ASTM D4169 is a framework. You choose a distribution cycle and an assurance level, which suits mixed routes or cases where you want to tune severity to risk. For pure parcel shipments, D4169 points you to D7386.[13]
Some companies run both to satisfy different customers or regions. Whichever you choose, write the rationale into the protocol: carriers, modes, maximum weight, climate and why the method represents them.
Do we age the package before or after transit testing?
Either order can work. ISO 11607-1 treats performance testing and stability testing as separate requirements, so decide the approach up front and document why.
Read more
Common approaches: age first, then transit test, then check sterile barrier integrity, which shows an aged package still survives distribution in one sample set; or run transit and aging on separate sample sets and check integrity on each.[4]
Accelerated aging under ASTM F1980 supports the shelf life claim early, with real-time aging running in parallel to confirm it.[10]
Test packages that have been through your real sterilization process, including the worst-case exposure your procedures allow, because sterilization can weaken materials and seals.
Does a newer edition of a standard change anything?
Yes, potentially. FDA recognizes specific editions, so testing to an edition FDA hasn't recognized counts as general use, not a declaration of conformity.
Read more
When FDA recognizes a new edition, it usually sets a transition period before withdrawing the old one. The recognition entry in FDA's database shows the edition and any transition date.[10]
If you must use a newer edition FDA hasn't recognized yet, submit it as general use, with your reasons and the underlying data, and note the differences from the recognized edition.[12]
Check the database when you write the protocol, not when you write the submission. Changing editions mid-program is expensive.
Does this apply to non-sterile devices?
Yes. ISO 11607 is specific to terminally sterilized devices, but every device has to arrive working.
Read more
ISO 13485 clause 7.5.11 and MDR Annex I Section 7 apply to every device, sterile or not.[2][3]
For a non-sterile device, the post-transit check is functional: does it power up, pass its self-test, hold calibration, and are the labels and instructions still readable? Define the pass criteria before the test, not after.
What changes mean we have to retest?
Anything that could change how the package or product responds to distribution. Assess each change under design change control and record the decision, even when the answer is no retest.[2]
Read more
Common triggers include: a new packaging material, supplier or design (including a different pouch, tray, foam or carton grade); a heavier, larger or more fragile product; a new sterilization method or more sterilization cycles; and a new route, carrier, mode or climate region, such as adding air freight or shipping into a hot market for the first time.
Smaller changes can often be covered by a documented comparison with the tested configuration, for example an equivalent material from a qualified supplier. The key is that the reasoning is written down and reviewed, not assumed.
A change in the standard itself, such as a new edition, doesn't automatically invalidate an old test. It matters the next time you submit or retest, because FDA recognition is edition-specific.[10]
Do we need to test every product and package?
Usually not. Most teams test the worst case of a product family and justify why it covers the rest.
Read more
Worst case usually means the heaviest product, the most fragile one, the largest or least-supported package, or the configuration with the least cushioning.
Write down the family, the worst-case choice and the reasoning. When a new product joins the family, check it against that rationale before deciding that no new test is needed.
References
- 21 CFR Part 820, Quality Management System Regulation (QMSR), §§ 820.7 and 820.10(a) and (c), incorporating ISO 13485:2016 by reference, effective 2 February 2026. www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820
- ISO 13485:2016, clauses 7.3.6 and 7.3.7 (design and development verification and validation, including statistical techniques with rationale for sample size), 7.3.9 (control of design and development changes), 7.3.10 (design and development files) and 7.5.11 (preservation of product). www.iso.org/standard/59752.html
- Regulation (EU) 2017/745 (EU MDR), Annex I, Sections 7, 11.4 and 23.2 (information on the label, including special storage and handling conditions). eur-lex.europa.eu/eli/reg/2017/745/oj
- ISO 11607-1:2019, Packaging for terminally sterilized medical devices — Part 1, clause 8 (packaging system performance and stability), and ISO 11607-2:2019 (validation of forming, sealing and assembly processes), each with Amendment 1 (2023). www.iso.org/standard/70799.html
- ISO 14971:2019, Medical devices — Application of risk management to medical devices, clauses 5.4 (identification of hazards and hazardous situations) and 7 (risk control). www.iso.org/standard/72704.html
- International Safe Transit Association (ISTA), test procedure types: 1 Series non-simulation integrity, 2 Series partial simulation, 3 Series general simulation, 4AB enhanced simulation, 6 Series member performance tests, 7 Series development tests. ista.org/refresh/test_procedures.php
- ISTA, Standard 20, Design and Qualification of Insulated Shipping Containers, and Test Standard 7E for thermal transport packaging in parcel delivery. ista.org/thermal_standards.php
- ISTA, Procedure 2A (2011), Packaged-Products 150 lb (68 kg) or Less, overview. ista.org/docs/2Aoverview.pdf
- ISTA, Procedure 3A (2018), Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less, overview. ista.org/docs/3Aoverview.pdf
- U.S. FDA, Recognized Consensus Standards database: ISTA 3A 2018 (5-126), ISTA 3B 2017 (5-127) and ISTA 3E 2017 (5-128), each entered 6 July 2020; ASTM D4169-22 (14-576); ASTM D7386-16 (5-113); ASTM F2825-18 (14-513); ASTM F1980-21 (14-575); ISO 11607-1 and 11607-2, 2019 with Amendment 1 (2023) (14-594, 14-595); ASTM F88/F88M-23 (14-596), F1929-23 (14-600), F2096-11 (R2019) (14-359) and F2338-09 (R2020) (14-282). www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
- U.S. FDA, Recognized Consensus Standards database, Table of Non-Recognized Standards: ISTA 2 Series Partial Simulation Performance Test Procedure 2A:2011, Packaged-Products 150 lb (68 kg) or less, with CDRH rationale. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/nr_results.cfm
- U.S. FDA, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, final guidance, September 2018. www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices
- ASTM D4169-23e1, Standard Practice for Performance Testing of Shipping Containers and Systems (scope, including the reference to ASTM D7386 for single parcel shipments). store.astm.org/d4169-23e01.html
- ASTM D7386-25, Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems (scope; shipping units up to 150 lb / 68 kg). store.astm.org/d7386-25.html
- Commission Implementing Decision (EU) 2021/1182 on harmonised standards for medical devices (consolidated), entries for EN ISO 11607-1:2020 and EN ISO 11607-2:2020, each with A1:2023. eur-lex.europa.eu/eli/dec_impl/2021/1182/oj
- ISO/TS 16775:2021, Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2; FDA recognition number 14-585. www.iso.org/standard/76555.html
Standard editions and FDA recognition numbers were checked against FDA's database in November 2026; check the current database and the full standards before relying on them.