Hello, how can we help you?

ASTM F1980

Nano-Test® > Research > Standards > ASTM F1980

ASTM F1980

ASTM F1980, published by ASTM International, is the “Standard Guide for the Accelerated Ageing of Sterile Barrier Systems and Medical Devices”, that is, the “Standard Guide to the Accelerated Ageing of Sterile Barrier Systems and Medical Devices”. The current version is ASTM F1980-21. The standard is in the nature of a Guide; whilst it does not prescribe any specific test protocol, it does provide a framework and calculation methods for the scientifically sound and reproducible design of accelerated ageing tests.

Regulatory status and associated standards: ASTM F1980 is used in the field of sterilisation and packaging of medical devices alongside ISO 11607-1 (Packaging of medical devices intended to be sterilised and supplied in a sterile state – Part 1: Requirements for materials, sterile barrier systems and packaging systems). Whilst ISO 11607-1 defines the requirements for shelf life and stability, ASTM F1980 provides the method for evaluating these requirements under accelerated conditions. The standard is recognised by the FDA and is frequently used to substantiate shelf life in technical documentation under the EU MDR (2017/745). Recent revisions to version ASTM F1980-21, as well as additional guidance published by the ASTM, should be reviewed prior to submission.

Basic principle: The Arrhenius approach

ASTM F1980 is based on the Arrhenius equation to describe the temperature dependence of chemical degradation and material ageing. As the material degradation process accelerates at high temperatures, the effects of long-term ageing (at room temperature) can be simulated in a short period of time. However, this approach is based on the assumption that the degradation mechanism does not change within the relevant temperature range; the scientific justification for this assumption is of crucial importance.

Q10 factor and accelerated ageing factor (AAF)

In practice, a simplified form of the Arrhenius equation is used:

  • Q10: Ein Koeffizient, der angibt, um wie viel sich die Reaktionsgeschwindigkeit bei einem Temperaturanstieg um 10 °C erhöht. Bei der Verpackung medizinischer Produkte wird in der Regel Q10 = 2 angenommen (die Reaktionsgeschwindigkeit verdoppelt sich bei jedem Anstieg um 10 °C). Diese Annahme muss je nach Materialtyp und Zersetzungsmechanismus begründet werden; für bestimmte Polymere und Klebstoffe können andere Q10-Werte (z. B. 1,8–2,5) besser geeignet sein.
  • Accelerated Ageing Factor (AAF): AAF = Q10(TAA − TRT)/10 is calculated using this formula. Here, TAA is the accelerated ageing temperature and TRT is the real-time (ambient) temperature.
  • Accelerated ageing time (AAT): AAT = Target shelf life / AAF.

Example: If a shelf life of 3 years is targeted at 25 °C and ageing is to take place at 55 °C (assuming that Q10 = 2): AAF = 2(55−25)/10 = 2³ = 8. AAT = 3 years / 8 ≈ 137 days (approx. 4.6 months); this accelerated ageing is considered equivalent to 3 years of real-time ageing.

Selection of the ageing temperature

ASTM F1980 recommends careful selection of the temperature for accelerated ageing:

  • Temperatures of 50 °C, 55 °C or 60 °C are usually used.
  • The temperature must be below the melting, softening or tack-destruction temperatures of the materials used in the sterile barrier system. Otherwise, artificial degradation may occur which would not occur under real-world conditions.
  • In einigen Fällen wird empfohlen, zwei verschiedene Temperaturen (z. B. 45 °C und 55 °C) zu verwenden, um die Arrhenius-Beziehung zu validieren.
  • In the case of moisture-sensitive materials, relative humidity must be monitored as well as temperature.

Correlation with real-time ageing

Die beschleunigte Alterung sollte durch Echtzeit-Alterungsversuche untermauert werden. ASTM F1980 empfiehlt, die Ergebnisse der beschleunigten Alterung lediglich als Ausgangsdaten zu verwenden und die Haltbarkeit letztendlich anhand von Echtzeitdaten zu bestätigen. Es muss nachgewiesen werden, dass die während der beschleunigten Alterung beobachteten Veränderungen denselben Mechanismus /strong> wie die Veränderungen bei der Echtzeit-Alterung

follow.

Evaluation criteria

Following accelerated ageing, the following properties of the sterile barrier system are assessed (in accordance with ISO 11607-1):

  • Visual inspection (integrity, adhesive joints, marking)
  • Integrity of the microbial barrier (e.g. ASTM F1929 dye penetration test, ASTM F88 barrier strength test, ASTM F1140 burst pressure test, ASTM F2096 bubble emission test)
  • Peel strength (peel strength)
  • Physical and mechanical properties (puncture resistance, tensile strength)
  • Sterility (together with sterilisation validation)
  • Chemical compatibility (compatibility between adhesive and material)
  • Legibility and adhesion of the lettering

The key parameters reported in the study are:

  • Target shelf life and storage conditions
  • Selected temperature for accelerated ageing (TAA) and real-time temperature (TRT)
  • Q10 value and scientific rationale
  • Calculated AAF and AAT values
  • Relative humidity and environmental conditions
  • Während der Alterung überwachte Parameter und Zeitpunkte
  • Sterile barrier system, materials and sterilisation methods used
  • Results of the physical, mechanical and barrier tests following ageing
  • Correlation with real-time ageing
  • Data on measurement uncertainty and repeatability

Why is this being done?

ASTM F1980 is used for the following scientific and regulatory purposes:

  • Determination of shelf life: Scientific evidence of how long the sterile barrier system and the medical device maintain their function under the specified storage conditions
  • Compliance with ISO 11607-1: Demonstration that the performance requirements of the packaging system are met throughout the entire shelf life
  • MDR compliance: Documentation of the justification for shelf life in the technical dossier in accordance with the EU Medical Devices Regulation (2017/745)
  • Patient safety: Maintaining the guarantee of sterility by ensuring the integrity of the sterile barrier until the end of the shelf life
  • Product development: Evaluation of new packaging materials, adhesives and sterilisation methods
  • Assessment of changes in suppliers and materials: Revalidation of the shelf life following a change of supplier for packaging materials or adhesives
  • Reducing time to market: In cases where real-time ageing can take years, facilitating a faster product launch through accelerated ageing
  • Assessment of transport and storage conditions: Assessment of the effects of real-world logistical conditions in conjunction with distribution simulation standards such as ASTM D4169
  • Support with regulatory documentation: Use as evidence of shelf life and packaging integrity in FDA 510(k), EU MDR and other applications

ASTM F1980 alone does not guarantee either sterility or the overall performance of the packaging system. The results should be interpreted in conjunction with data from sterilisation validation (ISO 11135, ISO 11137, ISO 17665), packaging tests (ISO 11607-1/2, ASTM F88, F1929, F2096, F1140) and real-time ageing data.

At NanoTest, we plan and carry out accelerated ageing tests in accordance with ASTM F1980 with scientific rigour, within the framework of our accredited laboratory infrastructure and our quality management system.

For your accelerated ageing tests in accordance with ASTM F1980, please contact NanoTest for information on test planning, the selection of the ageing temperature and the Q10 value, the AAF/AAT calculations, sample preparation, post-ageing tests and reporting procedures.

Standards