The IAEA is launching a new Coordinated Research Project (CRP) to advance our understanding of radiation effects on polymer materials commonly used in medical devices by comparing the effects of gamma, e-beam, and X-ray irradiation.
Polymers are widespread in healthcare products, such as single-use medical devices, implants, drug delivery and packaging systems, because of their versatility and economic advantages, including low weight and ability to withstand sterilization processes. Around 50 per cent of all single-use polymer-based medical devices manufactured worldwide are sterilized using ionizing radiation from two main sources – the cobalt-60 radioisotope (gamma irradiation), or an electron accelerator, using either e-beams or, less commonly, X-rays. While all the above irradiation modalities are recognized in the applicable ISO standards, gamma irradiation dominates the radiation sterilization market and accelerator-based sterilization methods are only utilized for around10% of products.
There are multiple reasons for the historical underutilization of accelerator technologies for sterilization, and the lack of knowledge about the radiation effects on polymers for e-beam and X-ray is one of them. However, interest in accelerator-based sterilization is increasing. This CRP will help to better understand the mechanisms underlying radiation effects from gamma, e-beam, and X-ray irradiation of polymers. Reliable data on radiation effects on polymers can help improve the legislative landscape and standards related to accelerator-based sterilization of medical products and devices, which in turn will help increase access to accelerator-based sterilization. Expanding radiation sterilization methods will have a collateral benefit aligned to UN Sustainable Development Goals.
CRP overall objective
The primary goal of this CRP is to investigate radiation effects on polymer materials commonly used in medical devices by comparing gamma, e-beam, and X-ray irradiation.
Specific research objectives
This CRP will focus on polymers commonly used in the medical industry, such as low-density polyethylene, polypropylene, poly (ether-block-amide) thermoplastic elastomers, polytetrafluoroethylene, and others. The experimental design of the studies should take into account irradiation conditions, namely total dose and its uniformity, dose rate, temperature, and irradiation environment (normal or oxygen-free). In addition, evaluation of the irradiated samples should involve at least one of the following areas:
- Physical and chemical analysis;
- Biocompatibility studies;
- Ageing studies;
- Functionality studies.
Proposals are welcomed from both experimental and theoretical (modelling) research groups and collaboration with the IAEA Collaborating Centres is encouraged.
How to join the CRP
Please submit your Proposal for Research Contract or Agreement by email, no later than 30 November 2020, to the IAEA’s Research Contracts Administration Section, using the appropriate template on the CRA web site.
For further information related to this CRP, potential applicants should use the contact form under the CRP page.
