ISO 10993 Biocompatibility and Risk Management

ISO 10993 Biocompatibility and Risk Management of Medical Devices

Burgeoning alongside advancements in the medical industry itself, innovations in medical devices have blossomed over the past few centuries. Even before a rolled up notebook to hear a woman’s heart in 1816 served the initial makeshift duty of a stethoscope and long before exalted technologies like robotics and lithium-ion batteries made their way into the industry, the biocompatibility of patients with medical devices has been crucial.

Essential to comprehending the harm inflicted onto humans by medical devices is risk management, a concept featured throughout the ISO 10993 series of international standards for the biological evaluation of medical devices.

Risk Management and the Biological Evaluation of Medical Devices

The term medical device covers an expanse of devices, ranging from a single material to numerous components made of a plenitude of materials.

Similarly, the range of biological hazards is wide and complex. Besides the five million trillion trillion (5×10^30) bacteria occupying planet earth, a variety of medical device materials and components available are utilize, each enhancing the variability for adverse effects.

Adverse biological responses from one application might not be considered adverse in another application. Furthermore, biocompatibility is just one of several factors that determine the functionality of a medical device.

To protect humans from hazards, biological evaluations of medical devices address a variety of issues. Since biological hazards often result from risk, this falls within a risk management process.

According to ISO 10993-1:2018 – Biological Evaluation Of Medical Devices – Part 1: Evaluation And Testing Within A Risk Management Process, a “biological risk” is understood as the:

“combination of the probability of harm to health occurring as a result of adverse reactions associated with medical device or material interactions, and the severity of that harm.”

Testing of Medical Devices Within a Risk Management Process

ISO 10993-1:2018, describes the biological evaluation of medical devices within a risk management process. This document specifies other integral provisions for this process, including assessing the biological safety of and categorizing a medical device, as well as the identifying gaps in a data set through risk analysis and additional data sets needed for analysis.

ISO 10993-1:2018 applies to biological evaluation of active, non-active, implantable, and non-implantable medical devices. The materials this standard evaluates are expected to have direct contact with either the patient’s body during the intended use of the medical device or, if used for protection, the user’s body, (as with surgical gloves and masks).

Chemical Characterization of Medical Device Materials Within a Risk Management Process

According to principles in ISO 10993-1:2018, biological risk analysis depends on knowledge of the material formulation, existing nonclinical and clinical safety and toxicological data, and the nature and duration of body contact with the medical device.

ISO 10993 Biocompatibility and Risk Management of Medical Devices

Expanding upon these requirements, ISO 10993-18:2020 – Biological Evaluation Of Medical Devices – Part 18: Chemical Characterization Of Medical Device Materials Within A Risk Management Process specifies a framework for the identification and quantification of constituents of a medical device. Such a framework allows for the identification of biological hazards and the estimation and control of biological risks from material constituents.

Using a stepwise approach, the chemical characterization in accordance with ISO 10993-18:2020 can yield information on medical device configuration, material composition, extractables, leachables, and/or the chemical substances introduced during manufacturing process (e.g. mold release agents, process contaminants, and sterilization residues).

ISO 10993 Standards

Just as medical devices cover an expansive range of components and materials, other documents in this family focus on a range of pertinent areas. These include:

ISO 10993-2:2006 – Biological Evaluation Of Medical Devices – Part 2: Animal Welfare Requirements

ISO 10993-3:2014 – Biological Evaluation Of Medical Devices – Part 3: Tests For Genotoxicity, Carcinogenicity And Reproductive Toxicity

ISO 10993-4:2017 – Biological Evaluation Of Medical Devices – Part 4: Selection Of Tests For Interactions With Blood

ISO 10993-5:2009 – Biological Evaluation Of Medical Devices – Part 5: Tests For In Vitro Cytotoxicity

ISO 10993-6:2016: Biological Evaluation Of Medical Devices – Part 6: Tests For Local Effects After Implantation

ISO 10993-7:2008 – Biological Evaluation Of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals

This standard has a corrigendum document published in 2009.

ISO 10993-9:2019 – Biological Evaluation Of Medical Devices – Part 9: Framework For Identification And Quantification Of Potential Degradation Products

ISO 10993-10:2010 – Biological Evaluation Of Medical Devices – Part 10: Tests For Irritation And Skin Sensitization

ISO 10993-11:2017 – Biological Evaluation Of Medical Devices – Part 11: Tests For Systemic Toxicity

ISO 10993-12:2012 – Biological Evaluation Of Medical Devices – Part 12: Sample Preparation And Reference Materials

ISO 10993-13:2010 – Biological Evaluation Of Medical Devices – Part 13: Identification And Quantification Of Degradation Products From Polymeric Medical Devices

ISO 10993-14:2001 – Biological Evaluation Of Medical Devices – Part 14: Identification And Quantification Of Degradation Products From Ceramics

ISO 10993-15:2019 – Biological Evaluation Of Medical Devices – Part 15: Identification And Quantification Of Degradation Products From Metals And Alloys

ISO 10993-16:2017 – Biological Evaluation Of Medical Devices – Part 16: Toxicokinetic Study Design For Degradation Products And Leachables

ISO 10993-17:2002 – Biological Evaluation Of Medical Devices – Part 17: Establishment Of Allowable Limits For Leachable Substances

ISO 10993-18:2020 – Biological Evaluation Of Medical Devices – Part 18: Chemical Characterization Of Medical Device Materials Within A Risk Management Process

ISO/TS 10993-19:2020 – Biological Evaluation Of Medical Devices – Part 19: Physico-Chemical, Morphological And Topographical Characterization Of Materials

ISO/TS 10993-20:2006 – Biological Evaluation Of Medical Devices – Part 20: Principles And Methods For Immunotoxicology Testing Of Medical Devices

All these standards are available together as the ISO 10993 – Biological Evaluation of Medical Devices Package.

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