GB/T 4857 Transport Tests for Medical Packaging: Test Sequence and Report Marks

When Chinese medical device manufacturers validate transport packaging, a national standard series they frequently cite is GB/T 4857, "Packaging — Basic tests for transport packages". Each method part sets out one type of test. Which tests to run, in what order and at what severity is decided separately in the test plan, and the accreditation mark a report can carry depends on the standard you choose. This guide covers what each of the seven GB/T 4857 parts in SUNGO's Hefei laboratory scope tests and which transport hazard it represents, how to combine them into a validation sequence, and which mark a GB/T 4857 report can carry, including when to switch to YY/T 0681.15-2019.

Key points

• The CNAS scope (L24279) of Hefei SUNGO Medical Technology Co., Ltd. (the Hefei laboratory) covers seven GB/T 4857 parts: GB/T 4857.2-2005 temperature and humidity conditioning, GB/T 4857.4-2008 stacking, GB/T 4857.5-1992 drop, GB/T 4857.7-2005 fixed-frequency vibration, GB/T 4857.10-2005 sinusoidal variable-frequency vibration, GB/T 4857.13-2005 low pressure and GB/T 4857.23-2021 random vibration. The scopes of Shanghai SUNGO Medical Technology Co., Ltd. contain no transport simulation standards.
• These seven parts are in the Hefei CNAS scope only, not its CMA or IAS scopes, so a GB/T 4857 report can carry the CNAS mark but not the CMA mark, and cannot be issued as an IAS-accredited report.
• If a dossier, reviewer or client requires the CMA mark, the only transport simulation standard the Hefei laboratory can issue a CMA report for is YY/T 0681.15-2019, limited to the seven items in the CMA schedule and applicable to shipping units for sterile medical devices. Its CNAS scope is also the 2019 edition, limited to the seven listed items; the IAS scope lists YY/T 0681.15 as a whole standard with no year stated.
• The Hefei CNAS certificate limits conditioning items to "only -40 °C to 150 °C". This applies to GB/T 4857.2 and to the conditioning items under YY/T 0681.15, ASTM D4169, ISTA 2A and ISTA 3A; the CMA schedule for YY/T 0681.15 carries the same limit.
• Unlisted parts such as GB/T 4857.3 (static-load stacking), GB/T 4857.9 (water spray) and GB/T 4857.11 (horizontal impact) are outside SUNGO's accreditation scope.
• The order of the sequence is set by the distribution environment, the product standard that cites the tests, or the client's plan. The GB/T 4857 method parts do not prescribe a fixed order.

The GB/T 4857 series and its scope

GB/T 4857 is managed by the national packaging standardization committee (TC49). All parts are recommended (voluntary) national standards, and the specimen is the transport package. The ISO counterparts of several parts use the phrase "complete, filled transport packages", meaning the package as actually shipped, contents included. The table shows the std.samr.gov.cn platform entries for the seven parts in SUNGO's scope, checked on 2026-10-22; all are current.

GB/T 4857.23-2021 replaces the 2012 edition. The platform title says "vertical random vibration", while the Hefei CNAS certificate says "random vibration"; the number is the same, so it is the same standard. GB/T 4857.5 is still the 1992 edition: the platform shows a review on 2023-12-28 concluding that it remains valid, and the certificate lists the same edition.

Parts outside SUNGO's scope

Many parts are not on SUNGO's certificates, for example GB/T 4857.1-2019 (identification of parts when testing), GB/T 4857.3-2008 (stacking with a static load), GB/T 4857.9-2008 (water spray), GB/T 4857.11-2005 (horizontal impact), GB/T 4857.15-2017 (controlled horizontal impact) and GB/T 4857.17-2017 (compiling performance test schedules). If your plan calls for them, those items are outside SUNGO's accreditation scope and need discussing before you order. GB/T 4857.1 and GB/T 4857.17 are not test methods, but both are useful references when writing a plan.

What each part tests, and which hazard it represents

Conditioning: GB/T 4857.2-2005

Its ISO counterpart, ISO 2233:2000, is titled "Conditioning for testing". The standard sets out temperature and humidity conditioning of the package before testing; refer to the standard text and the plan for the conditioning atmosphere and duration.

The Hefei CNAS certificate limits this item to "only -40 °C to 150 °C"; conditioning outside that range is outside the accreditation scope. The limit concerns temperature only, so confirm any specific humidity requirement with the laboratory before ordering.

Stacking: GB/T 4857.4-2008

This represents a package at the bottom of a warehouse stack or vehicle load carrying the weight above it for a long time. GB/T 4857.4-2008 is identical to ISO 12048:1994, whose abstract describes two methods on the same apparatus: a compression resistance test and a stacking test. The item on the Hefei CNAS certificate is "stacking test"; if you need a stand-alone compression result, confirm with the laboratory first. The plan sets the stacking load and duration and should state how the load was calculated.

GB/T 4857.3-2008 (identical to ISO 2234:2000) applies a static load instead of a compression tester. It is a different method and outside SUNGO's scope.

Drop: GB/T 4857.5-1992

This represents drops during manual handling, loading, unloading and sorting. The ISO 2248:1985 abstract describes raising the package above a rigid flat surface and releasing it to strike the surface in free fall, with the atmospheric conditions, drop height and package attitude fixed in advance. The plan should therefore state the drop height, the number of drops and the face, edge or corner that strikes each time.

Vibration: GB/T 4857.7, GB/T 4857.10 and GB/T 4857.23

Vibration represents road, rail and air vehicles in motion. The Hefei scope includes three methods:

• GB/T 4857.7-2005, fixed-frequency sinusoidal vibration (MOD ISO 2247:2000). The ISO abstract says it assesses a package's strength, or the protection it gives its contents, under low-frequency vibration, either alone or as part of a sequence where the distribution system includes low-frequency vibration or repetitive shocks.
• GB/T 4857.10-2005, variable-frequency sinusoidal vibration (MOD ISO 8318:2000). The ISO abstract says it gives two methods for assessing strength or protection under vertical vibration, each usable alone or within a sequence.
• GB/T 4857.23-2021, random vibration (MOD ISO 13355:2016). The ISO 13355:2016 abstract says it is a vertical random vibration test on complete, filled transport packages using random excitation, for assessing strength or protection under vertical vibration, either alone or as part of a sequence.

The choice follows the standard text and the plan or product standard: some specify random vibration with a power spectral density, others only sinusoidal vibration. The plan should state the source of the frequency, acceleration, spectrum and duration; this guide gives no values.

Low pressure: GB/T 4857.13-2005

This represents reduced air pressure in air transport. The ISO 2873:2000 abstract says the method exposes packages to low air pressure similar to that in aircraft. A pressure difference across a sealed package stresses it. If the route has no air leg, the plan can omit this test; if it does, the plan sets the pressure and duration.

Building a transport validation sequence

Each method part stands alone; combining them is a matter for the plan. A useful reference is GB/T 4857.17-2017, "General rules for the compilation of performance test schedules" (MOD ISO 4180:2009). The ISO 4180:2009 abstract says it gives guidelines for compiling schedules where the distribution environment is known and measured data exist, gives schedules based on specimen mass and destination where it is unknown, and lists factors for setting acceptance criteria. GB/T 4857.17 is outside SUNGO's scope. ISO 4180:2009, which it adopts, has since been replaced by ISO 4180:2019, and the platform shows a 2025-07-01 review of GB/T 4857.17 concluding "revise", with a revision project in progress, so use whichever edition is current.

One common combination, purely as an example:

1. Conditioning (GB/T 4857.2-2005) to the state set in the plan.
2. Stacking (GB/T 4857.4-2008) for warehouse and vehicle stacking.
3. Vibration (GB/T 4857.23-2021, or GB/T 4857.7-2005 / GB/T 4857.10-2005 if the plan requires) for vehicle transport.
4. Drop (GB/T 4857.5-1992) for handling and final delivery.
5. Low pressure (GB/T 4857.13-2005) when the route includes air transport.

The GB/T 4857 method parts do not prescribe this order; it should follow the real distribution process (where the distribution environment is unknown, GB/T 4857.17 above may help; refer to the standard text). If packages are handled manually at both ends, the plan can include drops at the start and the end. If the air leg is mid-journey, low pressure can sit between two vibration stages. Where the product standard or client plan already fixes the order and severities, follow it. The distribution cycle and acceptance criteria are the client's decision.

What to settle first

• Route: road, rail, air or parcel carrier; warehouse stacking or not; full cartons or single parcels.
• Severity and its source: drop heights and attitudes, stacking load and duration, vibration parameters and low pressure conditions, each traced to a named standard or plan.
• Acceptance criteria: appearance, function of the contents, sterile barrier integrity and so on, fixed before testing, not after seeing results.
• Sample size: based on the severity of possible failures and the risk you can accept.

How GB/T 4857 relates to YY/T 0681.15, ASTM D4169 and ISTA

GB/T 4857 provides single-test methods. The scope of YY/T 0681.15-2019 says it gives a uniform laboratory method for assessing whether shipping units for sterile medical devices can withstand the distribution environment, guiding users to design a plan that exposes the unit to the hazards expected in a specific distribution cycle; it does not cover single-parcel shipments. Section 1.1 of ASTM D4169-23e1 likewise evaluates shipping units with a test plan made up of a sequence of hazard elements anticipated in various distribution cycles. ISTA 2A and ISTA 3A are complete test procedures; the Hefei CNAS certificate names them "partial simulation performance test procedure" and "general simulation performance test procedure" respectively.

ASTM D4169-23e1, ISTA 2A(11-22) and ISTA 3A(18-22) are also in the Hefei CNAS scope, but only for the items and test objects listed: all three carry a package weight limit, and ISTA 3A is further limited to packages shipped as parcels (exact wording in the table below). Each has IAS exclusions and none has CMA. Choosing between these programmes is covered in a separate guide on our Chinese site and is not repeated here.

Which mark the report can carry

The choice between GB/T 4857 and YY/T 0681.15 often comes down to the mark the report needs. Across the Hefei laboratory's three certificates:

• GB/T 4857 reports carry the CNAS mark only. The CNAS certificate states that CNAS is a signatory to the ILAC and APAC mutual recognition arrangements.
• If you need the CMA mark, base the plan and report on YY/T 0681.15-2019. The CMA mark covers only items in the CMA schedule, and the certificate states it is valid within the People's Republic of China. YY/T 0681.15 applies to shipping units for sterile devices, not single-parcel shipments.
• If you need an IAS report, use YY/T 0681.15, ASTM D4169, ISTA 2A or ISTA 3A, avoiding the exclusions above. The IAS scope states no edition years, so confirm the edition with the laboratory before an IAS report is issued.
• Methods outside the certificates cannot be reported as accredited items; agree how to handle them before ordering.
• Whether a regulator or client accepts a report is their decision; SUNGO makes no commitment on acceptance.

Accreditation scope tables

The seven GB/T 4857 rows in the Hefei CNAS scope (L24279), all with the test object "transport packages". No clause numbers are listed; the accredited items are those named on the certificate (for GB/T 4857.4-2008, the stacking test only). GB/T 4857 is not in the Hefei CMA or IAS scopes.

For the comparison standard YY/T 0681.15-2019 the test object is "sterile medical device packages". Clause numbers are from the CNAS schedule; the CMA schedule lists the same seven items without clauses; the IAS scope lists YY/T 0681.15 as a whole standard, with no year or clause, so the clauses and limits below apply to CNAS and CMA only.

Where the work is done, and under which accreditation

• All transport simulation is done in Hefei: Hefei SUNGO Medical Technology Co., Ltd., laboratory in Zipeng Town, Feixi County, Hefei, Anhui, holding CNAS L24279, CMA 260015342945 and IAS TL-1119. The accreditation for each standard is in the table above.
• Shanghai does not do transport simulation: the scopes of Shanghai SUNGO Medical Technology Co., Ltd. (laboratory at No. 958 Kangqiao East Road, Pudong; CNAS L22083, CMA 240015340087, IAS TL-1019) contain no transport standards. For sterile barrier testing after transport, its CNAS and CMA scopes include YY/T 0681.2-2010 (seal strength) and YY/T 0681.4-2021 (dye penetration), and its IAS scope includes YY/T 0681.2 and YY/T 0681.4 (whole standard, no year stated; confirm the edition with the laboratory before an IAS report is issued). See sterile packaging validation.
• The two companies are separate legal entities, each issuing reports under its own certificates. If samples go through transport testing and then integrity testing, plan the transfer between sites in advance.

Preparing samples and documents

• Specimens: complete, filled transport packages as shipped, with inner packaging, cushioning, outer carton, closure and labels matching production. If you use simulated contents, explain why in the plan.
• Test plan: parts and editions (numbers with years), order, each step's parameters and source, acceptance criteria and any intermediate inspection points.
• Package data: mass, outer dimensions, stacking orientation and limits, transport modes and route, and whether air transport is involved.
• Climate: check that conditioning temperatures fall within "-40 °C to 150 °C" and confirm humidity needs in advance.
• Part identification: drop attitudes refer to numbered parts of the package; GB/T 4857.1-2019 sets out the method, so agree on numbering when ordering.
• Report mark: state whether you need the CNAS, CMA or IAS mark, because it determines which standard can be used.

Frequently asked questions

Can a GB/T 4857 report carry the CMA mark?

No. The seven GB/T 4857 parts are in the Hefei CNAS scope only. For shipping units of sterile medical devices that need the CMA mark, the plan and report can be based on YY/T 0681.15-2019, limited to the seven items in the CMA schedule.

Can you issue an IAS report to GB/T 4857?

No, the Hefei IAS scope does not include GB/T 4857. Its transport standards are YY/T 0681.15, ASTM D4169, ISTA 2A and ISTA 3A, the last three with the exclusions shown above.

Must the sequence be conditioning, stacking, vibration, drop, low pressure?

No. That is one common approach; the GB/T 4857 method parts set no fixed order. The order follows the distribution environment, the citing product standard or the client's plan.

Can conditioning below -40 °C be done within the accreditation scope?

Not under the CNAS certificate or the CMA schedule: both limit conditioning items to "only -40 °C to 150 °C", so conditioning outside that range is outside those two scopes. If you need it, confirm how it will be handled with the laboratory before ordering.

For a quotation, tell us the product and packaging structure, package mass and dimensions, distribution route, the standards and parts you plan to use (or your existing plan), the report mark you need, and whether you need integrity testing after transport. The Hefei laboratory will then confirm whether each item is in its accreditation scope. Send your request through our contact page; service details are on our transport simulation testing page. GB/T 4857.4 stacking, GB/T 4857.23 and GB/T 4857.10 vibration, GB/T 4857.5 drop, and GB/T 4857.13 low pressure will each be covered in later guides.