ISO 13485 and its Application in Plastic Injection

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.

• Polycarbonates are most well-known for their impact and temperature resistance properties and their applications include plastic lenses in eyewear, automotive components, protective gear, and medical devices.
• Polypropylene steam-sterilized medical devices necessarily require polypropylene.
• Polyethylene is a versatile, durable thermoplastic often used in medical implants. It can withstand harsh cleaning agents and does not fade nor retain dangerous bacteria.

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.

Proper choice of material characteristics to medical devices design

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:

• Temperature.
• Chemical contact and resistance.
• Applied stresses during use.
• Transparency/opacity.
• Color used to aid in identification.
• Aesthetics.
• Water absorption.
• Lubricity and wear resistance.
• Sterilization resistance and toughness.

For plastic injection molding for medical devices, several considerations must be taken into account during the design, planning and manufacturing processes. These are:

• ISO certification and compliance — ISO 13485 regulations govern processes and outputs in the medical industry. At a minimum, a facility producing medical components must meet ISO 13485 standards. In addition, standards for biocompatibility, such as ISO 10993, may also be required depending on the risk classification of the device.
• Material properties — Specific physical properties must be considered for material chosen for medical components and devices. These include:
• Ability to be contaminant-resistant — In order to prevent harm to those with whom they interact, materials must be contaminant-resistant and able to be sterilized.
• Ability to handle extreme environments —When exposed to environmental factors like heat, liquid, corrosives, vibration and other movement, and bio-implants must be able to handle the difficult environment.
• Durability —Ensure that your selected material offers the shatter and breakage resistance necessary in the medical field.

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.

Who requires ISO 13485?

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.

Who requires ISO 13485?

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 device manufacturers.
• Medical device developers (software).
• Manufacturers of medical device parts or components.
• Providers of services for medical device installation, maintenance, or servicing.

Medical devices considered include instruments, implants, machines, or in vitro reagents used in diagnosing or preventing diseases.

What are benefits of ISO 13485?

The benefits of ISO 13485 cannot be overstated. The following is a list of top reasons to implement ISO 13485 in your company:

• Enhance company’s credibility and image.
• Enhance customer satisfaction.
• Improve overall system and processes.
• Improve decision-making.
• Create a culture of continual improvement.
• Better employee engagement.
• Clarification of management responsibilities.
• Enhanced training.
• Facility improvements.
• Enhanced control surrounding design & development.
• Enhanced controls of suppliers.

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:

• Traceability is the ability to trace something. It is also, in some cases, interpreted as the capability to verify the history or previous record, place or location, or application of product by means of documented recorded identification.
• Process validation contributes significantly to ensuring the quality of the medical device. Validation means testing that expected results and objectives have been achieved in those stages where verification cannot be done, for processes affected by computer software in production, and for sterilization and sterile barrier systems.
• Risk management involves the identification, understand, control, and prevent failures that can result in hazards when people use medical devices. Is a key aspect to ensure device usability, safety, and regulatory compliance.

Requirements of ISO 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:

• Specific work environment requirements
• Contamination control requirements
• Specific production requirements for cleanliness of products
• Specific production requirements for sterile medical devices

Comparison of ISO 13485 and ISO 9001:

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:

• Risk management required at all stages of the manufacturing medical device.
• Training and supervision of staff.
• Contamination prevention.
• Multiple documentation requirements.
• Effective customer requirements monitoring, rather than mere subjective customer satisfaction measures.
• Maintaining the continued suitability and effectiveness of the quality management system, rather than striving for continuous improvement.
• Validation of production process

Hence it could be safely recommended that ISO 13485 is the most appropriate QMS for plastic medical devices or medical injection molding plants.