ISO 10993-18: An Introduction to Chemical Characterization of Medical Devices

Mike Ludlow

By Engaged Expert

Mike Ludlow

More content from this author

Learn about our Engaged Experts

Market Development Manager for E&L at Element Life Sciences Manchester. 25+ years of pharmaceutical analysis specialising in trace impurity analysis and extractables and leachables.

Discover the intricacies of ISO 10993-18 in our informative webinar. Decoding the complexities of medical device chemical characterization, our Extractables & Leachables (E&L) expert, Mike Ludlow delves into standardized extraction methods and analytical techniques. Learn how studies are designed to effectively navigate regulatory landscapes, ensure product compliance, and enhance patient safety.


Click here to watch our webinar.


Unique challenges require complex ISO 10993-18 studies involving the use of multiple analytical techniques

As medical devices become more complex and diverse, the importance of robust experimental study design, taking into considerations the device type, mode of use, and material composition (including understanding the impact of biodegradable and recycled polymers) is clear-cut.

Mike emphasizes how the analytical methodology for extraction studies, developed and correctly implemented by a testing partner, must cover a wide range of chemical functionalities and impurity levels, necessitating the use of multiple analytical techniques. Additionally, the advancements in the areas of combination drug devices, medical implants and improved consumer healthcare products all introduce new considerations and challenges in testing protocols. 

Industry experience and strong partnerships help to ensure evolving regulatory compliance

Mike explains how an effective study requires a comprehensive understanding of regulatory requirements, analytical methodologies, and the specific characteristics of medical devices under evaluation. Additionally, ongoing collaboration and communication among industry stakeholders, regulatory bodies, and testing laboratories are all essential in driving progress toward compliance. Meeting the demands of different regulatory bodies adds another layer of complexity due to the varying requirements.


The benefits of watching this webinar

  • Gain comprehensive insights into ISO 10993-18 for effective medical device chemical characterization.
  • Learn about study design, considering component nature and end-use scenarios.
  • Enhance product development strategies by aligning with industry standards and scientific best practices.
  • Stay ahead of evolving regulatory landscapes and technological advancements for accelerated device compliance.
  • Empower decision-making with a deeper understanding of experimental design and risk assessment principles.
  • Discover how standardized extraction methods and analytical techniques are implemented to ensure accurate assessments.
  • Optimize safety evaluations with detailed toxicological assessments and threshold considerations.
  • Navigate regulatory requirements with more confidence.


Click here to watch our webinar.


Key topics covered in this webinar

  • Introduction to chemical characterization of medical devices according to ISO 10993-18.
  • Understanding E&L and their potential impact on product safety.
  • Discussion on experimental design considerations for E&L studies.
  • Overview of ISO 10993-18 guidelines and their application in medical device evaluation.
  • Examination of standardized extraction conditions for diverse product usage scenarios.
  • Analysis Assessment of different extraction techniques and solvent selection for comprehensive E&L assessment.
  • Utilization of analytical methodologies including GC-MS, LC-MS, and ICP-MS for targeted and non-targeted screening of E&L.
  • Incorporation of risk assessment strategies for setting analytical evaluation thresholds (AET).
  • Considerations for future developments in medical device testing and regulatory compliance.

Webinar Abstract

Discover the intricate world of ISO 10993-18 guidelines with this webinar. Explore the chemical characterization of medical devices, from understanding extractables to experimental design nuances. Uncover the importance of standardized extraction conditions, solvent selection, and analytical methodologies in supporting regulatory compliance and product safety.

Gain invaluable insights into risk assessment strategies to mitigate potential hazards and help ensure patient well-being. Join us on a journey to master the complexities of medical device evaluation, empowering you to navigate industry standards with confidence and precision.


Excerpt from the webinar

"The main thing that we need to consider when we're considering how to design studies is the actual nature of the component that we're looking to extract."

Find related Resources

Watch our pre-recorded ISO 10993-18 webinar today!

Click 'Watch Today' to watch 'An Introduction to the Chemical Characterization of Medical Devices'.

Mike Ludlow

About the author

As Market Development Manager at Element Life Sciences Manchester, Mike Ludlow has over 25+ years of pharmaceutical analysis specialising in trace impurity analysis and extractables and leachables.

Graduating as a chemist, Mike began his career in the analytical lab of a multinational chemical company, before focusing on NMR and LCMS in the spectroscopy area. Before joining Element in June 2023, Mike led an analytical function specializing in extractable and leachable testing, offering expert support globally.

Mike is dedicated to assisting our clients in bringing forward innovative products that enhance the well-being and comfort of patients.


Related Pages

Pharmaceutical Testing Extractables and Leachables

Extractables and Leachables Studies

Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.

Read More

Medical Device Testing

As a comprehensive testing partner, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing and environmental simulation to EMC and wireless device testing.

Read More
pharmaceutical testing

Pharmaceutical Testing

Element’s pharmaceutical laboratories provide specialist pharmaceutical testing services, including chemical, physical, microbial, and stability testing on a vast array of products, from raw materials to finished products.

Read More
IS0 18562-2

ISO 18562 Testing: Biocompatibility Analysis

Element provides ISO 18562 biocompatibility analysis for respiratory and ventilation devices to support global device approval.

USP 665 Testing

USP 665, 1665 and BPOG Services

Ensure compliance for single-use systems (SUS). Our testing services provide high-quality results, safeguarding patient safety, fulfilling your regulatory requirements, and expediting time to market.

Pharmaceutical raw materials testing

Excipient Raw Materials and Container Testing

Find out how we make certain that quality and safety of your excipient raw materials and containers are maintained.

Connect with Element Life Sciences.

Chemistry, Manufacturing, and Controls (CMC) Consulting Services

We provide consulting services for Chemistry, Manufacturing, and Controls (CMC) product development in the pharmaceutical and biotechnological industries.

Connect with Element Life Sciences

ICH Stability Testing of Pharmaceuticals and Biologics

We'll help you develop comprehensive stability programs that meet ICH Q1A-F requirements for IND, ANDA, and NDA approvals of small and large molecule drugs. 

Read more

Our team of over 9,000 Engaged Experts in North America, Europe, The Middle East, Australia, Asia and Africa are ready to help you.