Home blood pressure monitors, oxygen concentrators and nebulizers sold online usually ship one unit per box, as parcels sent straight to the user through a parcel network. Teams planning transit testing for them ask three questions: ISTA 3A or ISTA 2A; what 3A tests and how a pass is decided; and, at SUNGO, which accreditation each test block can be reported under. This article answers them from ISTA's public 3A overview and the SUNGO Hefei laboratory's accredited scope.
Key Points First
- Who it is for: ISTA 3A covers individual packaged-products of 70 kg (150 lb) or less shipped through a parcel delivery system, by air or ground. Home-use devices shipped directly to online buyers fit this pattern.
- Classify first: 3A sorts packages into standard, small, flat and elongated types, each with its own sequence. Flat and elongated packages add a rotational edge drop, a full rotational flat drop, and a concentrated or bridge impact. Packages with liquids finish with a leak test.
- Versus 2A: 2A is an ISTA 2 Series partial simulation; 3A is a 3 Series general simulation. The ISTA 2A overview itself suggests considering 3A for packaged-products that may travel in a small parcel delivery system.
- What SUNGO can report: the Hefei laboratory's CNAS scope lists five 3A items covering Test blocks 1 (limited to -40 °C to 150 °C), 3, 9, 4, 5, 6, 7 and 14; its IAS scope covers ISTA 3A except random vibration under low pressure; 3A is not in the CMA scope. Required blocks for standard and small packages are all within the CNAS listing, while Test blocks 10 to 13 for flat and elongated packages are within the IAS scope only.
- Not covered by either: the optional random vibration under low pressure (Test blocks 2 and 8) is not listed under CNAS and is excluded under IAS.
The Standard and Its Scope
Title and edition
ISTA 3A is an ISTA 3 Series General Simulation Performance Test Procedure titled "Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less". As of 22 October 2026, ISTA's change history lists March 2018 as the most recent technical change to 3A, which added a test block (and a definition) for packaged-products containing liquids, followed by an editorial change in July 2022 that removed the "Reporting an ISTA Test" section. The Hefei CNAS scope writes the standard as ISTA 3A(18-22); the IAS scope states no edition year, so confirm the edition with the laboratory before an IAS report is issued.
As of 22 October 2026, the US FDA Recognized Consensus Standards database lists ISTA 3A 2018 with recognition number 5-126 (entered July 6, 2020; extent of recognition: complete standard).
Scope and assumptions
Per the ISTA overview, 3A covers individual packaged-products of 70 kg (150 lb) or less prepared for shipment via a parcel delivery carrier, by air or ground. Other ISTA procedures convert 150 lb to 68 kg; 3A uses 70 kg because it is a common dividing point in parcel delivery systems. Assumptions to keep in mind:
- Test levels are based on general data and may not represent any specific distribution system.
- The package and product are evaluated together, not separately.
- Some transit conditions, such as moisture, pressure or unusual handling, may not be covered.
- 3A is not a substitute for United Nations or other required dangerous goods tests and should be used as an additional test in conjunction with them; lithium battery requirements are handled separately.
The four package types
Definitions paraphrased from the ISTA overview:
| Type | Definition |
|---|---|
| Small | Volume less than 13,000 cm³ (800 in³), longest dimension 350 mm (14 in) or less, and weight 4.5 kg (10 lb) or less; all three must be met |
| Flat | Shortest dimension 200 mm (8 in) or less, next longest dimension four or more times the shortest, and volume 13,000 cm³ (800 in³) or greater |
| Elongated | Longest dimension 900 mm (36 in) or greater, and each of the other two dimensions 20 percent or less of the longest |
| Standard | Anything not meeting the small, flat or elongated definitions, such as fiberboard cartons or plastic, wooden or cylindrical containers |
A package that is both flat and elongated is tested as elongated.
ISTA 3A vs ISTA 2A
Both address individual packaged-products but simulate the transport environment to different degrees. ISTA describes the 2 Series as a more thorough screening test for refining preliminary designs, not intended to predict shipping performance, and the 3 Series as a simulation of the damage-producing motions, forces, conditions and sequences of transport, useful as a predictive tool for damage risk. Comparing the two overviews:
| Item | ISTA 2A | ISTA 3A |
|---|---|---|
| Series | Partial simulation combining 1 Series and 3 Series elements; simulates only some hazards | General simulation of actual transport hazards |
| Scope | Individual packaged-products, 68 kg (150 lb) or less | Individual packaged-products, 70 kg (150 lb) or less, via parcel delivery |
| Package types | Not classified | Standard, small, flat, elongated |
| Compression | Compression test (one of three methods) | No separate compression test; vibration with and without top load |
| Vibration | Two vibration sequences, each either fixed displacement or random | Random vibration, plus optional random vibration under low pressure |
| Shock | Drop, incline impact or horizontal impact (select one) | Two drop series, the second including a hazard drop; extra shocks for flat and elongated |
| Liquids | No dedicated test block | Leak test (Test block 14) required for liquids |
| FDA recognized standards database | A keyword search for "ISTA" (22 October 2026) did not return 2A | ISTA 3A 2018, recognition number 5-126 |
| SUNGO scope | Hefei CNAS (five items; temperature/humidity conditioning only -40 °C to 150 °C; for shock, only the drop test is listed) and IAS (excluding incline and horizontal impact) | Hefei CNAS (five items) and IAS (excluding random vibration under low pressure) |
Why e-commerce shipments line up with 3A
In e-commerce the shipping unit is usually a single device's retail box, sometimes with an outer carton, handled many times alongside parcels of all shapes and weights rather than palletized. 3A mirrors this: two drop series reflect repeated handling, the second including a drop onto a hazard; random vibration runs with and without top load; small packages run the vibration under dynamic load (Test block 6) and the second drop series (Test block 9) using consolidation bags with dunnage packages to simulate a typical pack; and the optional random vibration under low pressure simulates high altitude, with truck-only or truck-and-air conditions listed in the overview. The final choice still depends on actual distribution, registration requirements and customer agreements.
Test Sequence and Test Blocks
Each sample is tested in the order shown in the table; optional blocks are set in the test plan, and some blocks apply only to certain package types or to packages containing liquids. The table follows the ISTA overview and shows test levels only where the overview gives them; drop heights, vibration breakpoints and durations are in the full procedure. The "Requirement" column follows the overview's "For ISTA Certification" column, which refers to ISTA's own certification program, not to SUNGO's CNAS or IAS accreditation. Standard, flat and elongated packages:
| Seq. | Test | Test block | Test level shown in the overview | Requirement |
|---|---|---|---|---|
| 1 | Atmospheric preconditioning | Test block 1 | Ambient temperature and humidity | Required |
| 2 | Atmospheric conditioning (controlled temperature and humidity) | Test block 1 | Temperature and humidity chosen from chart | Optional |
| 3 | Drop | Test block 3 | 9 drops, height varies with packaged-product weight | Required |
| 4 | Random vibration with and without top load | Standard: Test blocks 4 and 7; pails and short cylinders: Test blocks 5 and 7 | Overall Grms levels of 0.53 and 0.46 | Required |
| 5 | Random vibration under low pressure | Test blocks 2 and 8 | Truck or truck and air dependent | Optional |
| 6 | Drop | Test block 9 | 8 drops, height varies with weight, includes drop on hazard | Required |
| 7 | Rotational edge drop | Test block 10 | 200 mm (8 in) | Required for flat and elongated |
| 8 | Full rotational flat drop | Test block 11 | Varies with packaged-product dimensions | Required for flat and elongated |
| 9 | Concentrated impact | Test block 12 | Hazard box dropped 400 mm (16 in) | Flat only |
| 10 | Bridge impact | Test block 13 | Hazard box dropped 400 mm (16 in) | Elongated only |
| 11 | Leak test | Test block 14 | 8 hours | Liquids only |
Small packages follow a shorter sequence: Test block 1 (conditioning optional); Test block 3, 9 drops not in a bag; Test blocks 6 and 7 random vibration; optional Test blocks 2 and 8; Test block 9, 7 drops in a bag; Test block 14 for liquids. No Test blocks 10 to 13.
Atmospheric preconditioning and conditioning (Test block 1)
Packages are preconditioned at ambient conditions; controlled conditioning from the procedure's chart is optional and is set in the test plan. Recorders follow ISO 2233 or ASTM D4332 apparatus sections. The SUNGO CNAS scope limits this item to -40 °C to 150 °C (translated from the Chinese CNAS schedule).
Drops (Test blocks 3 and 9)
The first series comes before vibration, the second after. Height varies with weight; the height table and the face, edge and corner sequence are in the full procedure. The drop tester follows ISO 2248 or ASTM D5276 apparatus sections, and the hazard block is hardwood or metal.
Random vibration (Test blocks 4, 5, 6 and 7)
Standard packages use Test blocks 4 and 7, pails and short cylinders 5 and 7, and small packages 6 and 7. Profile shape and durations are in the full procedure. The system follows ISO 13355 or ASTM D4728 apparatus sections, with a top-load apparatus. Small packages also need two consolidation bags: a top-load bag of sand or other dense, flowable material, and a sample bag with the specimen and dunnage packages (envelopes, padded mailers, small cartons). The overview ties the bags to Test block 6 (vibration for small), and the sequence table marks the first drop series as not in a bag and the second as in a bag; other placement details are in the full procedure. The SUNGO CNAS scope (translated from Chinese) lists Test blocks 4, 5 and 6 as a vibration test under dynamic load and Test block 7 as random vibration.
Random vibration under low pressure (Test blocks 2 and 8, optional)
Random vibration combined with low pressure (simulated high altitude) checks whether the primary or transport package holds its seal and keeps liquid, powder or gas contents from leaking. It is not listed under CNAS and is excluded under IAS.
Extra shock tests for flat and elongated packages (Test blocks 10 to 13)
After the second drop series come a rotational edge drop and a full rotational flat drop. Flat packages then get a concentrated impact (a hazard box dropped onto the package); elongated packages get a bridge impact (the package rests on two support blocks and is struck by a falling hazard box). These four blocks are within the SUNGO IAS scope but not listed under CNAS.
Leak test (Test block 14)
Added in 2018, it runs after all other 3A elements and evaluates the closure's ability to contain liquid. ISTA's definition covers liquids, semi-liquids and solids that can become liquid above 70 °F and could leak from a primary vessel.
How Pass or Fail Is Decided
3A sets no product acceptance criteria. The shipper must decide before testing what counts as product damage, what tolerance (if any) is allowed, how product condition will be assessed afterwards, and what package condition is acceptable. For medical devices:
- Put the criteria in the test plan and confirm them before testing, not after seeing results.
- Define product checks (appearance, loose or cracked parts, display and buttons, power-on self-test) from risk management and technical requirements. Performance testing such as measurement accuracy is not part of ISTA 3A and not among the accredited items here.
- State in advance how much carton damage, tape splitting or insert movement is acceptable.
- For liquids, include leakage after the leak test in the decision.
Blood Pressure Monitors, Oxygen Concentrators and Nebulizers
- Measure, then classify: measure and weigh the package as shipped, with accessories, instructions for use and any outer carton, then apply the definitions. Single-unit shipments and multi-unit cartons are different shipping units; assess them separately.
- Home blood pressure monitors: a single-unit package meeting all three small-package conditions is tested as small, using the consolidation bags for the vibration under dynamic load (Test block 6) and the second drop series; otherwise as standard.
- Home oxygen concentrators: the boxed unit usually exceeds the small-package volume or weight limits and is typically standard, but measurements decide. Lithium battery models need dangerous goods requirements handled separately.
- Nebulizers: a unit with accessories may be small or standard depending on measurements. Anything meeting the ISTA definition of liquids adds the leak test.
- Number of samples: the ISTA overview requires one performance (one sample), lists electronics among its fragile examples, recommends two or more samples for fragile and liquid products, and encourages five or more runs with new samples for all package types to improve statistical significance.
Accredited Scope Table
The rows below are taken from the CNAS scope (L24279) and IAS scope (TL-1119) of Hefei SUNGO Medical Technology Co., Ltd. Item names are translated from the Chinese CNAS schedule; the IAS row is quoted as issued. The CNAS rows apply to packaged-products of 70 kg (150 lb) or less shipped as parcels.
| Item | Clause | Notes / limitation |
|---|---|---|
| Temperature and humidity conditioning test | ISTA 3A(18-22) Test block 1 | CNAS; limited to -40 °C to 150 °C |
| Drop test | ISTA 3A(18-22) Test block 3, 9 | CNAS |
| Vibration test under dynamic load | ISTA 3A(18-22) Test block 4, 5, 6 | CNAS |
| Random vibration | ISTA 3A(18-22) Test block 7 | CNAS |
| Leak test | ISTA 3A(18-22) Test block 14 | CNAS |
| ISTA 3A (exclusion in the next column) | ISTA 3A (no edition year or clause stated in the IAS scope) | IAS; except for Random vibration under low pressure |
Where the Work Is Done and Under Which Accreditation
ISTA 3A testing is performed by Hefei SUNGO Medical Technology Co., Ltd. (CNAS L24279, IAS TL-1119), laboratory in Zipeng Town, Feixi County, Hefei, Anhui Province. Hefei SUNGO is an independent legal entity; Shanghai SUNGO Medical Technology Co., Ltd. (laboratory at No. 958 Kangqiao East Road, Pudong, Shanghai) is a separate company whose accreditations include no ISTA procedure. Report options by test block:
| Test block | Content | CNAS (L24279) | IAS (TL-1119) |
|---|---|---|---|
| Test block 1 | Preconditioning and conditioning | In scope (only -40 °C to 150 °C) | In scope |
| Test blocks 3, 9 | Two drop series | In scope | In scope |
| Test blocks 4, 5, 6 | Vibration block by package type | In scope | In scope |
| Test block 7 | Random vibration | In scope | In scope |
| Test blocks 10 to 13 | Rotational edge drop, full rotational flat drop, concentrated impact, bridge impact | Not listed | In scope |
| Test block 14 | Leak test | In scope | In scope |
| Test blocks 2, 8 | Random vibration under low pressure (optional) | Not listed | Excluded |
- CNAS accreditation covers only the five listed items; Test blocks 10 to 13 are outside the CNAS scope, so for all required flat or elongated blocks to be reported as accredited, use IAS (random vibration under low pressure excluded).
- The IAS scope states no edition year; confirm the edition with the laboratory before an IAS report is issued.
- ISTA 3A is not in the CMA scope, so no CMA-marked report is possible. CMA covers only items in its schedule and is valid only within the People's Republic of China.
- The CNAS certificate states that CNAS is a member of the ILAC and APAC mutual recognition arrangements, and the IAS certificate carries the ilac-MRA mark. Whether an overseas regulator or buyer accepts a report depends on their requirements; confirm in advance.
Preparing Your Samples
- Samples: untested actual product in actual packaging; substitutes, if needed, as identical as possible.
- Shipping to the lab: for samples shipped to an ISTA Certified Laboratory, ISTA requires them to be adequately over-packaged or repacked in new packaging at the laboratory; doing the same when shipping samples to SUNGO helps keep transit damage from affecting the test.
- Packaging details: provide carton material and flute type, board basis weight or grade, inserts and cushioning, closure method, and labels and orientation markings. ISTA stresses documenting configuration, materials and construction, with photos; if nominal corrugated basis weights change, a retest is appropriate even if the board is rated for the same performance.
- Dimensions, weight and type: give the shipping unit's dimensions, weight and your assigned package type; the laboratory will check it.
- Acceptance criteria: define damage, tolerance, product check method and acceptable package condition in advance, including power-on check steps if needed.
- Liquids and low pressure: state whether the package holds liquids or materials that may liquefy when warm; random vibration under low pressure is outside SUNGO's accredited scope.
- Report type: CNAS or IAS, and for which market or customer.
Frequently Asked Questions
Can ISTA 3A and ISTA 2A replace each other?
They simulate transport to different degrees and should not simply be swapped. For single parcels sent directly to users, 3A is the closer match, as the ISTA 2A overview also suggests.
Can an ISTA 3A report carry the CMA mark?
No. ISTA 3A is not in the Hefei CMA scope; in the transport area, the Hefei CMA scope covers only YY/T 0681.15.
What if our plan requires random vibration under low pressure?
It is not listed under CNAS and is excluded under IAS, so SUNGO cannot issue an accredited report for it. Confirm at the planning stage whether it is mandatory.
Does passing ISTA 3A mean a regulator will accept the results?
No. ISTA 3A 2018 is listed in the FDA recognized consensus standards database, but acceptance depends on the submission as a whole and on the review.
Requesting a Quote
For a quote, please provide the product name and model, the shipping unit's dimensions and weight, your assigned package type, whether it contains liquids, how it ships (single parcel or multi-unit carton), the target market, and whether you need a CNAS or IAS report. See the transport simulation testing service page for details, and send your request through the contact page.