Accelerated Aging – ASTM F1980

What Is Accelerated Ageing — ASTM F1980?

Accelerated ageing holds packaging and device materials at elevated temperature to speed up their degradation over time. ASTM F1980 defines a calculation method based on the assumption that chemical reaction rate increases with temperature (the Arrhenius approach), so a long shelf life is simulated in a short time.

Purpose of Accelerated Ageing — ASTM F1980

The purpose is to produce early evidence that the product will retain its packaging integrity and function at the end of the declared shelf life. This allows the product to be launched before real-time ageing is complete, while the real-time study continues in parallel.

Which Products Is Accelerated Ageing — ASTM F1980 Applied To?

Sterile barrier packaging
Single-use medical devices
Polymer-based device components
Adhesive products and tapes
In vitro diagnostic kits

In Which Sectors Is Accelerated Ageing — ASTM F1980 Used?

Medical DevicePharmaceuticalsHealthcareBiotechnology

Standards Related to Accelerated Ageing — ASTM F1980

ASTM F1980accelerated aging in packaging test

Accelerated Ageing — ASTM F1980 Conditions

Approach: Arrhenius-based acceleration; the acceleration factor is calculated from the temperature difference
Ageing temperature: Chosen so as not to change the material's degradation mechanism
Humidity: Relative humidity is also controlled for moisture-sensitive materials
Assessment: Packaging integrity, seal strength and device function after ageing

Equipment for Accelerated Ageing — ASTM F1980

Temperature- and humidity-controlled ageing chambers
Calibrated temperature and humidity loggers
Seal strength and integrity test equipment
Device function test rigs

Sample Requirements for Accelerated Ageing — ASTM F1980

Specimens must be prepared under series production conditions and in their final packaging.
The sterilisation process must be applied before ageing.
A separate specimen set must be reserved for each assessment point.
Specimens from the same batch must also be reserved for real-time ageing.
A reference set must be tested for the initial (T0) values.

Duration of Accelerated Ageing — ASTM F1980

Duration is calculated based on the declared shelf life and the chosen ageing temperature; duration shortens as temperature rises. In practice a typical study takes weeks. The real-time study continues for the declared shelf life.

Accelerated Ageing — ASTM F1980 Procedure

1The shelf life to be declared and the storage condition are defined.
2An ageing temperature suitable for the material is chosen and the acceleration factor is calculated.
3Initial (T0) tests are performed.
4Specimens are placed in the ageing chamber.
5Specimens are removed and conditioned at the end of the calculated duration.
6Transport simulation is applied if required.
7Packaging integrity, seal strength and device function tests are repeated.

Accelerated Ageing — ASTM F1980 Acceptance Criteria

The acceptance criterion is selected from the relevant section of the standard according to the device's contact type (surface, externally communicating, implant), contact duration and intended use. The assessment relies not on a single test result but on the biological evaluation plan carried out under ISO 10993-1; this page therefore gives no fixed limit.

Evaluation of Results

The assessment relies on comparing post-ageing results against the initial values and acceptance criteria. The accelerated result is interim evidence; the claim is confirmed once the real-time ageing data is complete.

Accelerated Ageing — ASTM F1980 Report

Device identification, model and lot number, if any
Device contact type, duration and intended use
Standard and section applied
Extraction or sample preparation conditions
Cell line, test system or test rig used
Controls and their results
Observations, measurement results and assessment
A statement that the result applies only to the specimen submitted for testing

Accreditation

EUROLAB holds internationally recognised accreditation obtained from accreditation bodies party to the IAF and ILAC multilateral recognition arrangements, under ISO/IEC 17025 for laboratory testing, ISO/IEC 17020 for inspection and surveillance, and ISO/IEC 17021-1 and ISO/IEC 17065 for system and product certification. This chain ensures the reports and certificates issued are accepted worldwide.

Whether this test can be offered within accredited scope depends on your product and the standard applied; since accreditation is method-based, the scope is confirmed in writing at the quotation stage.

Scope and authorisations

Related Regulations

EU 2017/745 Medical Device Regulation (MDR)
Medical Device Regulation (Türkiye)
ISO 14971 (risk management for medical devices)
ISO 13485 (medical devices — quality management system)

Medikal Cihaz Testleri — What Does This Testing Field Cover?

The section below describes the field that the Accelerated Ageing test belongs to; the conditions and acceptance criteria of this particular test are given in the sections above. The scope specific to your product is confirmed in writing at the quotation stage.

Medical device testing shows that a device is safe for the patient and the user and maintains its intended performance. In this family safety is not only about avoiding harm; a device failing to perform its expected function is also treated as a risk. A monitor missing an alarm or a pump delivering the wrong dose is directly a patient safety event.

At the centre of the field is RISK MANAGEMENT, and this is what sets medical apart from other sectors. The risk management process run under ISO 14971 also determines which tests are required. The test list is not copied from a table of standards; it is derived and justified from the device's intended use, the nature and duration of patient contact, the use environment and foreseeable misuse.

Assessment consists of several separate bodies of work, each with its own set of standards. Biocompatibility runs through the ISO 10993 series, electrical device safety through the IEC 60601 series, sterilisation through ISO 11135/11137/17665, packaging through ISO 11607, software through IEC 62304 and usability through IEC 62366. The quality system (ISO 13485) is the framework that binds these together.

Which tests are required is determined by the device's CLASS and its MODE OF CONTACT WITH THE BODY. A product in brief contact with skin and an implant entering the bloodstream do not go through the same test set; the scope is set by a biological evaluation plan prepared under ISO 10993-1. That plan justifies in writing which endpoints are required and why the others are not.

Packaging and sterilisation are taken as seriously as the device itself in this field. For a sterile device the packaging is not a transport container but the barrier that maintains sterility; if the barrier is breached, the device is no longer sterile. Packaging processes are therefore validated and shelf life is supported by real-time ageing data.

For devices containing software, assessment shifts from testing towards PROCESS assurance. IEC 62304 defines which development and verification steps must be followed according to the safety class of the software; the evidence is the traceability of the development process. Testing software does not make it safe — the process record does.

The clinical side is a separate column of the technical file. Test reports show that the device is technically safe; clinical evaluation establishes that the device delivers the intended clinical benefit and that the benefit-risk balance is acceptable. Neither replaces the other.

Method groups in this field

Biocompatibility
Cytotoxicity, irritation, skin sensitisation, systemic toxicity, haemocompatibility, genotoxicity and local effects after implantation. The required endpoints are set by the ISO 10993-1 plan.
Electrical device safety
IEC 60601-1 basic safety and essential performance; EMC, alarm, usability and environmental requirements through the collateral standards.
Sterilisation validation
Validation of sterilisation processes by ethylene oxide, radiation or moist heat; bioburden and sterility assurance level studies.
Packaging
Integrity of the sterile barrier system, seal strength, distribution simulation and shelf-life studies.
Microbiological tests
Bioburden determination, sterility testing, bacterial endotoxin and, where required, carrier validation studies.
Software and usability
IEC 62304 life cycle evidence and use-error focused evaluation under IEC 62366.

Commonly confused in this field

Cytotoxicity alone is not evidence of biocompatibility; the required set of endpoints is determined and justified according to ISO 10993-1.
An ISO 13485 certificate does not confer CE marking; classification under the MDR, the technical file and the notified body process run separately.
Accelerated ageing does not replace real-time ageing; a shelf life claim is supported by real-time data.
A change of material (supplier, pigment, sterilisation method) may require the biological evaluation to be repeated; it is not a silent change.
An assessment made without the collateral and particular standards for IEC 60601-1 is incomplete; which -1-x and -2-x standards were applied must appear in the report.
In vitro diagnostic devices fall under the IVDR rather than the MDR, and laboratory equipment is often on the IEC 61010-1 side.

Which decisions these results support

MDR/IVDR technical file and notified body assessment
Completing the biological evaluation plan
Sterilisation and packaging validation
Determining shelf life and storage conditions
Determining the scope of reassessment after a design change

Related Tests

Frequently Asked Questions About Accelerated Ageing — ASTM F1980

Can the ageing temperature be raised as much as desired?

No. The temperature must not be raised to a level that triggers a degradation mechanism not seen under the real storage condition; otherwise the result does not reflect reality.

Is a real-time study required?

Yes. ISO 11607 does not consider accelerated data sufficient on its own; real-time ageing is run in parallel and its results are used to confirm the claim.