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Medical plastic products have become a necessary and vital component in the modern healthcare system. Product durability, sterilization and biocompatibility are all important factors that must meet regulatory and safety requirements throughout the world. To guarantee that the plastic fabric is secure and successful, polymers for medical devices are for the most part made of thermoplastic materials.
Thermoplastics are synthetic polymer that can be remolded and reheated several times without causing any irreversible degradation. Thus, thermoplastics can be recycled and reused.
Biocompatibility and sterilization for medical devices. Biocompatibility refers to the “ability of a material to perform an appropriate host response in a specific situation”. Whereas “Sterilization refers to any process that removes, kills, or deactivates all forms of life and other biological agents present in a specific surface, object or fluid”. Sterilization and biocompatibility are must do actions for new medical devices. Based on the materials and components used, potentially suitable sterilization method and biological validation experiments have to be selected.
Plastic medical injection moldings primarily require quality operational controls. It is important to make proper design considerations when selecting a plastic for medical devices or components. In injection molding process, material selection, production process and part geometry are interlinked. The following usage conditions need to be considered in a plastic medical injection molding such as:
For plastic injection molding for medical devices, several considerations must be taken into account during the design, planning and manufacturing processes. These are:
Safety and quality are non-negotiable in the plastic medical devices industry. Organizations are increasingly required to implement suitable quality management system and are expected to demonstrate their quality management processes and thus ensure the best practice in everything they do. The internationally agreed standard of ISO 13485 sets out all the suitable requirements for a quality management system specific to the medical devices industry and plastic medical injection and ensure the safety of medical devices and its components.
Safety and quality are serious concerns in the medical devices industry. Organizations in the industry of medical devices are required to show the best quality and highest standards in everything they do. This is the reason why ISO 13485 was developed. It involves internationally agreed standards that set out the requirements for a Quality Management System that is specific to the industry of medical devices.
Certified organizations include those that are involved in the medical device life-cycle. Organizations can be involved in the development, design, storage, production, or installation of medical devices. They include:
Medical devices considered include instruments, implants, machines, or in vitro reagents used in diagnosing or preventing diseases.
The benefits of ISO 13485 cannot be overstated. The following is a list of top reasons to implement ISO 13485 in your company:
So basically, when a manufacture has 13485, you are guaranteed that they have clearly defined management, clean spaces, streamlined procedures, and accountability. There are 3 particular areas, however, that really gets supercharged with 13485:
Although it is not mandatory to become ISO 13485, it is still very important because it ensures that this specific organization has a world-class system that meets the needs of all customers and legislators. It also provides more than the minimum to meet all the legal requirements.
Becoming ISO 13485 certified means that this organization has met very strict requirements to ensure that this organization understands the requirements for creating high-quality medical devices. ISO 13485 certification is generally valid for three years and then the organization has to get re-certified to ensure quality maintenance.
Here are some of the mandatory requirements that are applied to organizations:
Quality Management System (QMS): This means that the organization should meet all expectations and requirements of the Quality Management System. The organization should also have the requirements for the Quality Manual, and Medical Device File.
Management Responsibility: It involves the presence of top management to be involved in the ongoing review of the system to make sure that customers are satisfied. There should be a commitment to the maintenance and implementation of a Quality Management System.
Resource Management: This involves the necessity to control all resources in the organization including buildings, infrastructure, human resources, and the working environment.
Product Realization: This deals with all aspects required for the planning and creation of medical devices. This includes requirements on planning, design, purchasing, creating the device, and the control of the equipment used to monitor and measure the product.
Measurement, Analysis and improvement: This requires the organization to make sure that they can monitor their Quality Management System and evaluate whether is it functioning well or not. You can consider it as a way to ensure that the Quality Management System remains effective.
Furthermore, there are more requirements in order to become ISO 13485. These are extra requirements that are not required by other certifications like ISO 9001. They include:
ISO 13485 is similar to the more commonly known ISO 9001 standard except that this is more specific to medical devices and its related parts. All stages of product realization such as product development, control documentation, risk management, traceability, complains management, labeling and manufacturing are covered by ISO 13485. Moreover, having this certificate is a requirement for complying for CE mark for sale into EU markets. FDA also recognizes ISO 13485 as appropriate safety standard for medical devices.
Key additional requirements of ISO 13485 from ISO 9001:
Hence it could be safely recommended that ISO 13485 is the most appropriate QMS for plastic medical devices or medical injection molding plants.