The International Organization for Standardization (ISO) is the largest body in the world publishing standards. In fact, it is a conglomeration of standards bodies from over 160 countries working together to harmonize standards. As such, ISO 10993 is the international standard that is practically used globally for testing and determining the biocompatibility of medical devices. So it’s critical for medical device manufacturers to understand all 23 parts of ISO 10993 for the success of 510(k), pre-market authorization (PMA), and other device submission projects for regulatory authorities worldwide. As an example, the FDA has issued guidance on the Use of International Standard ISO 10993-1.
According to ISO 10993-1:2018, the current version of part 1 of the standard, biocompatibility is the ability of a medical device or material to perform with an appropriate host response in a specific application. Any device that comes into direct or indirect contact with the skin must be tested for biocompatibility. A medical device that makes indirect contact with the skin is one that encounters a liquid, gas, or another medium, that makes direct contact with the patient or user.
When testing the biocompatibility of a device, it is broken down into two categories; one based on its type of contact with humans, and the other based on the duration of contact.
The categorizations for types of contact are:
The categorizations for times of duration are:
Medical devices are most commonly made of metals, plastics, and fabrics, which are composed of chemicals with varying properties. Manufacturers must gather physical and chemical information about the device, which is vital to its biological and material evaluation and characterization.
For devices with components that are made of or utilize novel chemicals or materials, or those known to cause adverse effects, ISO 10993 requires rigorous risk assessment and management according to the standards of ISO 14971. Furthermore, there are prescribed data endpoints that set the foundation for determining the biocompatibility of medical devices and their intended uses and components.
The main things manufacturers must consider when determining the biocompatibility of medical devices and their components are listed below:
Biocompatibility assessment is a vital part of risk management according to ISO 14971. Ensuring compliance with risk management and biocompatibility assessment standards requires buy-in from all departments, from marketing and design to quality assurance and regulatory affairs.
It is vital that you begin considering ISO 10993-1:2018 in the early stages of product design. Part 1 of the standard will refer to additional parts, as listed in the following section. Completing your complete chemical characterization and toxicology assessment early in the process will help ensure the biocompatibility of your medical device during the design phase and expedite your device registration and time to market.
Also, it’s important to note that many regulatory authorities around the world have their own variation of ISO 10993. While these varying standards have the same foundation and are similar in many ways, you must understand their nuances if you plan to offer your medical device internationally.
ISO 10993 is made up of 23 different sections or parts, each of which is maintained and updated separately. Previews of the standard can be viewed on the ISO website, but full versions of the standard need to be purchased.
Many manufacturers endure longer and more costly paths to market than necessary because they do not have systems and tools designed specifically for their regulatory teams. Furthermore, a lack of visibility and collaboration from departments that see regulatory teams traditionally as the “department of saying no” leaves ample room for human error in regulatory, quality management, and even marketing processes and activities. Read more about why we believe regulatory teams need to be considered revenue functions, not cost centers.
The resulting inefficiencies lead to problems such as marketing products with expired certificates, missing certificates, inaccurate and/or incomplete submissions, and even non-compliance with current regulatory requirements. Having a holistic RIM system is central to staying in compliance with standards, regulations, and guidance in the many markets around the world. Rimsys is the only RIM system of its kind built specifically for the medtech industry.
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