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ISO 10993-1 and Chemical Characterization of Medical Devices

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Date:                     June 12, 2019 (9:30-16:30)

Location:               Lyon - To be defined

Registration fee:   100€ - The registration fee is payable in advance.

Registration:           > Download Brochure    

Introduction

The new ISO 10993-1:2018 “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” has significantly impacted the approach to biocompatibility. This approach is now based on the review of relevant established scientific data, physico/chemical characterization and in vitro testing; in vivo testing is carried out only to fill gaps in our understanding. All device types will require a chemical characterization as a prerequisite for the risk assessment.

Data obtained from chemical characterization should be toxicologically assessed to elucidate the need for further tests to address the relevant biological endpoints.
In line with the risk management, the biological evaluation should be planned in advance (“Biological Evaluation Plan”), carried out and documented (“Biological Evaluation Report”) by knowledgeable and experienced professionals. Characterization studies are performed in order to gain a more complete understanding of a device, and of the risk factors associated with using a device. Also FDA is placing a greater emphasis on these studies – to better ensure patient safety.

This Workshop will provide a wide and comprehensive overview of critical aspects and latest updates on ISO 10993 series and the impact that on the medical devices industry. By attending, participants will gain valuable insight on how to plan and conduct the biological evaluation plan, and, more importantly, how such an evaluation sits within the activities of design control and risk management.

This Workshop, led by the biocompatibility industry expert in Eurofins, will also give the opportunity to bring your specific questions and case studies along to the Workshop for discussion. Benefit from the strong expert advice on how to overcome challenges and
implement successfully your biocompatibility testing strategy.

Agenda

09:30-11:15 What’s new in ISO 10993-1

11:15-11:30 Coffee break

11:30-13:00 Chemical characterization as a preliminary step for risk assessment
(ref. ISO FDIS 10993-18)

13:00-14:00 Lunch break

14:00-15:00 Toxicological evaluation of data (ref. ISO 10993-17)

15:00-15:30 Biological Evaluation Plan and Biological Evaluation Report

15:30-16:15 Case study

16:15-16:30 Q&A

Note: The official workshop language will be English.

Who should attend

This workshop offers a rewarding experience and is relevant to both specialist or beginner within biocompatibility, product safety, material specialist, within material characterization, R&D, production, process development or Quality Assurance/Regulatory Affairs.

Speaker

Paolo Pescio, ERT
European Registered Toxicologist with a M.S. in Biomedical Engineering has over 13 years of experience in biological evaluation of medical devices with a successful background as Test Facility Manager. He is Senior Consultant in Eurofins Medical Device Testing Italy, Healthcare Engineering HAS consultant for EU Commission and adjunt professor in “Regulatory aspects in toxicology - Legislation in European Union” at the University of Milan. Former Chairman of the UNI U4201 Committee for non-active medical devices for transfusion and biological evaluation is an active member of ISO TC194 and CEN TC206 groups.

All Items

The new ISO 10993-1:2018 “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” has significantly impacted the approach to biocompatibility. This approach is now based on the review of relevant established scientific data, physico/chemical characterization and in vitro testing; in vivo testing is carried out only to fill gaps in our understanding. All device types will require a chemical characterization as a prerequisite for the risk assessment.

Data obtained from chemical characterization should be toxicologically assessed to elucidate the need for further tests to address the relevant biological endpoints.
In line with the risk management, the biological evaluation should be planned in advance (“Biological Evaluation Plan”), carried out and documented (“Biological Evaluation Report”) by knowledgeable and experienced professionals. Characterization studies are performed in order to gain a more complete understanding of a device, and of the risk factors associated with using a device. Also FDA is placing a greater emphasis on these studies – to better ensure patient safety.

This Workshop will provide a wide and comprehensive overview of critical aspects and latest updates on ISO 10993 series and the impact that on the medical devices industry. By attending, participants will gain valuable insight on how to plan and conduct the biological evaluation plan, and, more importantly, how such an evaluation sits within the activities of design control and risk management.

This Workshop, led by the biocompatibility industry expert in Eurofins, will also give the opportunity to bring your specific questions and case studies along to the Workshop for discussion. Benefit from the strong expert advice on how to overcome challenges and
implement successfully your biocompatibility testing strategy.

09:30-11:15 What’s new in ISO 10993-1

11:15-11:30 Coffee break

11:30-13:00 Chemical characterization as a preliminary step for risk assessment
(ref. ISO FDIS 10993-18)

13:00-14:00 Lunch break

14:00-15:00 Toxicological evaluation of data (ref. ISO 10993-17)

15:00-15:30 Biological Evaluation Plan and Biological Evaluation Report

15:30-16:15 Case study

16:15-16:30 Q&A

Note: The official workshop language will be English.

This workshop offers a rewarding experience and is relevant to both specialist or beginner within biocompatibility, product safety, material specialist, within material characterization, R&D, production, process development or Quality Assurance/Regulatory Affairs.

Paolo Pescio, ERT
European Registered Toxicologist with a M.S. in Biomedical Engineering has over 13 years of experience in biological evaluation of medical devices with a successful background as Test Facility Manager. He is Senior Consultant in Eurofins Medical Device Testing Italy, Healthcare Engineering HAS consultant for EU Commission and adjunt professor in “Regulatory aspects in toxicology - Legislation in European Union” at the University of Milan. Former Chairman of the UNI U4201 Committee for non-active medical devices for transfusion and biological evaluation is an active member of ISO TC194 and CEN TC206 groups.