Sterile Barrier Package Testing for ISO 11607-1

This page is for regulatory, quality and packaging engineers who need ISO 11607-1 test evidence for a sterile barrier system (SBS), for a US 510(k), a notified body review or a registration in China, and for sourcing managers and Chinese OEMs who need to know which package tests SUNGO reports under accreditation, where, and to which edition.

It covers seal strength, integrity, microbial barrier, accelerated aging and distribution tests, and states plainly what we do not do.

Key points

• Seal strength and integrity tests run at the Shanghai laboratory: ASTM F88/F88M-23, F1929-23, F1140/F1140M-13(2025), D3078-02(2021)e1 and YY/T 0681 parts within CNAS accreditation L22083, and the same methods without edition years on IAS accreditation TL-1019 (ASTM F1140/F1140M Test Method A only).
• Accelerated aging is within CNAS scope to ASTM F1980-21 at both Shanghai and Hefei, and ASTM F1980 (no edition year listed) is on both IAS scopes. It is not on either laboratory's CMA schedule.
• Distribution simulation runs at the Hefei laboratory: ASTM D4169-23e1, ISTA 2A(11-22), ISTA 3A(18-22) and YY/T 0681.15-2019 for the listed elements within CNAS L24279, and the same standards without edition years on IAS TL-1119, with the exclusions below.
• ISO 11607-1, GB/T 19633.1 and ASTM F1886/F1886M are on the Shanghai IAS scope only, not on CNAS or CMA.
• Not in our scope: ISO 11607-2 process validation of forming, sealing and assembly; the package leak tests ASTM F2096, ASTM F2338 and ASTM F3039; and the EN 868 series.
• Both laboratories are accredited by CNAS and IAS, both signatories to the ILAC MRA. Whether a report is accepted is decided by FDA, notified bodies and other regulators, not by the laboratory.

What ISO 11607-1 expects from package testing

ISO 11607-1:2019 specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems intended to keep terminally sterilized medical devices sterile until the point of use. An amendment on the application of risk management was published in 2023.

Several testing requirements are decisions for the manufacturer's validation plan, not the laboratory. In the 2019 edition, sampling plans must rest on a statistically valid rationale (4.3), and a rationale is recorded for selecting the tests (4.4.1) and for the acceptance criteria (4.4.2). Clause 4.4.3 requires test methods to be validated and documented by the laboratory performing the test, a fair question to put to any laboratory, including us.

Clause 8 separates two kinds of evidence:

• Performance testing (8.2). The packaging system must protect the SBS and its contents through handling, distribution and storage hazards, tested on the worst-case SBS with the worst-case protective packaging, with a documented worst-case rationale.
• Stability testing (8.3). The SBS must keep its integrity over time. Stability testing is performed with real-time aging; accelerated aging is accepted as sufficient evidence for a claimed expiry date until real-time data are available, and a rationale for the chosen aging conditions and duration must be established (8.3.5).

SBS integrity testing follows performance and stability testing, on sterilized samples (8.1). Under clause 9.1, a packaging system that meets the design, usability, performance and stability requirements is considered validated if the SBS conforms to ISO 11607-2, which covers validation of forming, sealing and assembly processes. That work is done on the manufacturer's equipment and is outside SUNGO's scope.

For US submissions, FDA's guidance Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile (January 2024) recommends that the 510(k) describe the packaging, how it maintains sterility and the package test methods, but not package test data (Section V.A, item 5). A footnote recommends simulated distribution with integrity testing and simulated and/or real-time aging with seal strength testing, referring to the currently FDA-recognized version of ISO 11607.

What we test, and what we do not

Items in the "No" rows need another provider; send us your full test list and we will confirm which parts we can cover.

Seal strength and integrity tests (Shanghai)

Each row below is on the Shanghai CNAS schedule under the test object "medical device packaging materials". IAS scope TL-1019 lists no edition years, so we confirm the IAS edition at quotation. CMA applies only to the Chinese standards shown and is valid in mainland China only. See also our sterile packaging testing page.

Note on GB/T 15171: our CMA schedule lists the 1994 edition, which China's national standards platform shows as withdrawn. GB/T 15171-2025, our CNAS edition, has applied since February 1, 2026 and is no longer titled for flexible packages only. We confirm edition, method and accreditation mark at quotation.

Settle these points in your protocol before testing:

• ASTM F88/F88M measures the force to separate a test strip containing the seal and records the failure mode. It describes three specimen techniques (unsupported, supported 90° by hand, supported 180°) and recommends one technique throughout a test series, so your protocol should name it (ASTM F88/F88M-23 summary).
• ASTM F1929 applies to edge seals between a transparent material and a porous sheet (injection, edge-dip or eyedropper application) and detects channels equal to or larger than one formed by a 50 µm (0.002 in.) wire. It locates leaks but does not size them (ASTM F1929-23 summary).
• ASTM F1140/F1140M covers a burst test (Test Method A) and creep tests (Test Method B). Our IAS scope covers Test Method A only, so creep results can be reported under CNAS but not under IAS. The standard also notes that these methods do not necessarily correlate with seal strength measured by ASTM F88.
• ASTM D3078 detects gross leaks in flexible packages containing headspace gas; the standard notes that small leaks may not be detected.

Microbial barrier and porous material tests (Shanghai)

ISO 11607-1 addresses the microbial barrier properties of materials in clause 5.2. The Shanghai laboratory covers:

ASTM F1608 reports a log reduction value. The standard describes it as a relative comparison between porous materials, not a prediction of how a material will perform in a specific package (ASTM F1608-21 summary). For DIN 58953-6 or YY/T 0681.14 under conditions other than the wet method, ask at quotation which accreditation mark applies.

Accelerated aging (Shanghai or Hefei)

Both laboratories list ASTM F1980-21 and YY/T 0681.1-2018 on their CNAS schedules (Shanghai under the test object "medical device packaging materials", Hefei under the test object "accelerated aging"), and ASTM F1980 and YY/T 0681.1, without edition years, on their IAS scopes. Both CMA schedules list YY/T 0681.1-2018 only, so an ASTM F1980 result cannot carry a CMA mark at either site. See also our shelf-life testing service.

How the method works, from the ASTM F1980-21 summary and the guide's text:

• Time at an elevated temperature is converted to equivalent real time with an accelerated aging factor (AAF), calculated by the Arrhenius approach from Q10 (the aging factor for a 10 °C change in temperature) and the difference between aging and ambient temperatures; aging time is the desired shelf life divided by the AAF.
• The expiry date rests on a conservative estimate of Q10 and stays tentative until real-time aging is complete; more aggressive AAFs need documented correlation between accelerated and real-time results.
• The aging temperature should stay below any material transition and below the point where the SBS distorts. Whether to control humidity, and at what target, is a protocol decision to justify in writing.
• Real-time aging must run in parallel, to the full claimed shelf life, and be evaluated with the same test methods. Accelerated aging data are not to be used to set labeled storage conditions.
• Acceptance criteria are set before aging starts. Distribution, handling and shipping events are outside the scope of the guide; they belong to performance testing.

You define the temperatures, Q10, any humidity condition, target shelf life and pull points; we run the aging and test the aged samples to your protocol.

Distribution simulation (Hefei)

ISO 11607-1 (8.2.1, Note 1) lists shock and vibration, compression, temperature, humidity, mode of transportation and pressure changes as typical distribution hazards. The CNAS column shows only the elements on the Hefei CNAS schedule, where conditioning is limited to −40 °C to 150 °C. See also our transport simulation service.

Elements not on the CNAS schedule can be reported under IAS only where the IAS scope covers them. ASTM D4169 Schedules G and H, the ISTA 2A incline and horizontal impacts, and ISTA 3A random vibration under low pressure are on neither scope.

A typical test sequence

A common layout follows; your validation plan decides the final structure.

1. Agree the protocol. Worst-case SBS and protective packaging, sample sizes, acceptance criteria and the accreditation mark needed for each test.
2. Sterilize and set baselines. Samples go through your validated sterilization process; baseline (zero-time) samples are tested for integrity and seal strength.
3. Stability arm. Accelerated aging to ASTM F1980-21 at Shanghai or Hefei, alongside the real-time aging that you start and manage.
4. Performance arm. Conditioning and distribution simulation of complete packaging systems at Hefei to ASTM D4169, ISTA 2A, ISTA 3A or YY/T 0681.15.
5. Post-challenge testing. SBS integrity (for example ASTM F1929 or visual inspection) and seal strength (ASTM F88/F88M) at Shanghai, compared with baseline.

Some plans put aged packaging systems through distribution simulation. ASTM F1980-21 (8.6) recommends that combined approach when the material response to aging is not well understood, and notes that ISO 11607-1:2019 does not require it.

FDA-recognized editions compared with SUNGO's accredited editions

FDA recognition applies to the consensus standards themselves, not to SUNGO's laboratories. The table compares entries in the FDA Recognized Consensus Standards database with the editions on our scopes.

Where the editions differ (the F1140/F1140M reapproval year and ASTM D4169), agree with your regulatory team before testing which edition you will declare or justify. For ISO 11607-1 and ASTM F1886/F1886M, whose Shanghai IAS listing carries no edition year, we confirm the edition at quotation.

Accreditation at a glance

The two laboratories belong to separate legal entities; the Hefei company is not a branch of the Shanghai company. Both operate ISO/IEC 17025 management systems, including impartiality management, and are accredited by CNAS and IAS, both signatories to the ILAC MRA.

Shanghai laboratory: Room 218/219/223/225, Building B, No. 958 Kangqiao East Road, Pudong New Area, Shanghai. Hefei laboratory: Unit 03, Building 7, Wanmao Industrial Park, Pengyi Road, Zipeng Town, Feixi County, Hefei, Anhui.

What to send us and how to start

So we can check every item against our scopes before quoting, please send:

• Validation plan or protocol extract: tests, standard and edition for each, the accreditation mark needed (CNAS, IAS or CMA), sample sizes with their rationale, and acceptance criteria.
• SBS description: materials (porous or nonporous, transparent side), format (pouch, header bag, tray and lid, wrap), seal type, dimensions, protective packaging, shipping container and packed weight.
• Sterilization: the method and whether the samples have been through the worst-case process conditions in your plan.
• Aging parameters: ambient and aging temperatures, Q10 and its rationale, any humidity condition, target shelf life and pull points.
• Distribution profile: the standard and options chosen (for example the ASTM D4169 distribution cycle and assurance level), shipping mode and orientation.
• Method details: the F88/F88M technique, the F1929 dye application method, and whether you need the F1140/F1140M burst test, the creep test or both.
• Samples: quantities set by your plan, labelled by group (baseline, aged, distribution-tested); flat material for material-only tests such as microbial barrier or air permeance.

We reply with a scope check showing the laboratory and accreditation mark for each test, and agree the protocol before samples ship. To begin, send us your request, or browse all testing services.

FAQ

Can SUNGO validate our sealing process to ISO 11607-2?

No. ISO 11607-2 process validation, including qualification of the sealing process, is not on any SUNGO accreditation scope. We test samples that your validated process has produced.

Do you perform ASTM F2096 bubble or ASTM F2338 vacuum decay leak tests?

No. Neither method, nor ASTM F3039, is on our scopes. For integrity we offer ASTM F1929-23, ASTM D3078-02(2021)e1, YY/T 0681.11-2014 and GB/T 15171-2025 (method confirmed at quotation) within CNAS accreditation, plus ASTM F1886/F1886M under IAS; your validation plan decides whether they suit your package.

Will FDA accept your accelerated aging report?

Acceptance is decided by FDA, not by the laboratory. We test to ASTM F1980-21, an FDA-recognized consensus standard (recognition number 14-575), within CNAS accreditation at both laboratories; ASTM F1980 is also on both IAS scopes, which list no edition year. The aging conditions and their rationale come from your protocol.

Which accreditation mark will appear on our report?

ISO 11607-1 and ASTM F1886/F1886M can be reported under Shanghai's IAS accreditation only, ASTM F1980 under CNAS or IAS but never CMA, and CMA applies only to the Chinese standards on each CMA schedule and is valid in mainland China only.

Can aging, transit and integrity testing be split between Shanghai and Hefei?

Yes. Aging runs at either laboratory, distribution simulation at Hefei, and seal, integrity and microbial barrier tests at Shanghai. As separate legal entities, each laboratory reports its own tests under its own accreditation; we confirm the report arrangement in the quotation.

Plan your package testing with us

Preparing an ISO 11607-1 validation, a 510(k) sterility section or a shelf-life extension? Send us your plan and package description, and we will tell you which tests we can run, where, under which accreditation, and what to source elsewhere. Contact SUNGO Lab to start.