Accelerated Ageing — ASTM F1980

What Is Accelerated Aging?

Accelerated ageing produces early shelf-life data by accelerating the degradation of the packaging material and sterile barrier system at high temperature over time. It is based on the Arrhenius approach: an equivalent real time is calculated on the assumption that a temperature increase raises the rate of chemical degradation.

Purpose of Accelerated Aging

The purpose is to provide preliminary evidence that the product retains packaging integrity and seal strength at the end of its declared shelf life, and to be able to make a shelf-life declaration before market launch.

Which Products Is Accelerated Aging Applied To?

Sterile barrier systems
Sterile medical device packaging
Implant packaging
Adhesive-taped and heat-sealed packaging

In Which Sectors Is Accelerated Aging Used?

Medical DeviceHealthcarePharmaceuticals

Standards Related to Accelerated Aging

ASTM F1980accelerated aging in packaging test
ISO 11607-1end product sterile barrier packaging test
ASTM F88peeling resistance in sealing seam test
ASTM F1929
ASTM F2096
ISO 11607end product sterile barrier packaging test

Accelerated Aging Conditions

Ageing temperature: Chosen so as not to change the material's degradation mechanism; commonly 50–60 °C
Q10 factor: The coefficient used in the acceleration calculation; a conservative approach of taking 2.0 is common
Humidity: Controlled humidity may be applied depending on the material

Equipment for Accelerated Aging

Temperature- and humidity-controlled ageing chamber
Seal-strength tester
Integrity test equipment
Data logger

Sample Requirements for Accelerated Aging

Sterilised specimens in their final packaging
A sufficient number of specimens must be set aside per time point
Time-zero (t0) reference specimens must be set aside
The number of specimens must be determined with statistical justification

Duration of Accelerated Aging

Depends on the targeted shelf life and the chosen temperature; typically takes several months for a five-year shelf life.

Accelerated Aging Procedure

1The target shelf life, ageing temperature and Q10 factor are determined.
2The equivalent ageing time is calculated.
3Time-zero specimens are tested and reference values are recorded.
4Specimens are placed in the ageing chamber.
5Specimens are taken at the planned time points.
6Seal strength, integrity and aseptic openability are tested.
7Results are compared with the time-zero values.

Accelerated Aging Acceptance Criteria

The acceptance criterion is that the packaging continues to meet its pre-defined seal-strength and integrity criteria at the end of ageing. The criteria are determined by the organisation and justified in the validation plan.

Evaluation of Results

Results are evaluated as a trend across time points. Accelerated data is a prediction; it is not finally accepted until confirmed with real-time ageing data.

Accelerated Aging Report

Target shelf life and calculation parameters (temperature, Q10, equivalent time)
Specimen description and sterilisation information
Time-zero reference results
Test results by time point
Comparison with acceptance criteria

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

MDR (EU) 2017/745
ISO 11607-1

Medikal Cihaz Testleri — What Does This Testing Field Cover?

The section below describes the field that the Accelerated Aging 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 Aging

Why do we take the Q10 factor as 2?

Q10 expresses by how many times the reaction rate increases when temperature rises by 10 °C. If no material-specific data exists, taking 2.0 as a conservative approach is common; if a higher value is chosen, it is expected to be justified.

Can I raise the ageing temperature further to shorten the duration?

This is limited. If the temperature rises to a level that changes the material's glass-transition or melting behaviour, the degradation mechanism differs and the result does not represent real ageing. The temperature choice must be justified.