Introduction to Plastics & Rubber Materials in Medical Devices
This Course will take place over 2 days, 10.00-17.00 on the first day and 09.00-15.30 on day 2.
Depending upon the application and classification of a medical device and/or accessories, the use of a plastic or rubber material in its manufacture may require consideration of biocompatibility, traceability, sterilisation techniques and their impact, manufacturing environment, regulation and testing, in addtition to the engineering requirements and capbilities of the material to be used.
This course will concentrate on providing an introduction to the material requirements and manufacturing conditions which may apply and will explore the scope and impact of the European Medical Device Directive (MDD) Regulations in relation to their use.
The objective is to provide companies entering the medical device and/or accessories supply chain manufacturing or supplying plastic or rubber products, or already supplying into it but with little experience of using these materials, with an insight into the requirements that they need to consider and meet.
Who will benefit?
Moulders and fabricators considering supplying medical device companies:
- Technical Managers, Quality Managers and others needing insight into the material and manufacturing and quality systems requirements and scope of MDD regulations which may apply when making medical devices or medical grade materials.
Existing suppliers or medical device manufacturers with little or no experience of engineering with plastics or rubber materials:
- Designer/Engineers and Technical/Production Managers and others needing to understand the additional material specific considerations, the scope of the MDD regulations in relation to their use and how these may differ from traditional engineering materials.
- Setting the Scene: the regulatory impact on requirements for performance of plastics and rubber materials in medical devices - while the EU Medical Devices Directive (MDD) does not specifically mention polymer materials, it does impact on the chemical, physical and microbiological requirements for performance of polymer materials, including sterilisation and bio-burden. This section will provide an overview and guidance on the parameters and impact of the regulations with regard to plastics and rubber materials.
- Overview of the EU Medical Devices Directive (MDD) - Medical Devices and accessories are subject to classification rules according to the degree and time of contact with the patient. An explanation of the classification system will be given. The relationship between the Medical Device classification and European Standards such as ISO 10993 and harmonised European Standards will be discussed.
- Quality Management Systems for Medical Devices - An overview of the Quality System Standards ISO13485 and ISO9001 will be presented, with a focus on the sections of ISO13485 that address essential requirements of the Medical Devices Directive.
- Introduction to the Medical Device Risk Assessment Standard ISO 14971 - ISO14971 is an important harmoised standard that details the requirements for the application of a risk management system for medical devices. The last revised version: ISO14971:2012 applies to manufacturers placing medical devices on the market in Europe. An overview will be given of this medical device risk management standard, which will explain the actions that should be taken to meet the requirements of this standard.
- Material Selection for Medical Devices, including sterilisation methods and their impact - a review of the different types of plastics and rubber materials which can be used for medical devices and accessories. A method of material selection criteria will be explored focussing on the special considerations needed to ensure a device performs safely. An important consideration is disinfection or sterilisation.
- Manufacturing Environment for Medical Devices: options and requirements - An overview of the manufacturing arrangements needed for medical devices and where these differ from other products.
- An overview of biocompatibiltiy and types of testing - An overview will be given which will provide a general introduction to the subject and the types of tests that can be employed to assess the interaction between medical devices and patients. The contents and scope of the international biocompatibility standard, ISO 10993 will be included and a comparison provided of how the EU and USA/FDA biocompatibility testing requirements and application of this standard differ from one another.
- Packaging Systems for Medical Devices - Medical Devices are required to provide the desired function after they have passed through the distribution system from manufacturer to patient. Packaging systems are an integral part of the function of a medical device. Requirements for packaging systems will be discussed with reference to performance specified by European Standards, including integrity and testing.
This activity is approved for Professional Development by the Institute of Materials, Minerals and Mining.
+44 (0)1939 252312
Approved for Professional Development by IOM3