New ISO 10993-17 : 2023 - General and new features
Overview
Objectives I Skills and Abilities
Understand the methodology for the toxicological assessment of medical device components in accordance with ISO 10993-17:2023.
Programme
ISO 10993-17, BACKGROUND AND CONTEXT OF THE UPDATE
Part 1 - Introduction
Scope (releasables, raw materials, degradation products, risks covered)
Links with other ISO 10993 standards (-1, -18, -9 etc.) - When is it useful and/or essential?
ISO 10993-17 (2002) VS ISO 10993-17 (2023) : A NEW APPROACH
Part 2 - What's new
New terms, definitions and concepts
New approaches: taking into account time periods; adapting exposure by weight (previously tolerable intake by weight).
Part 3 - Data generation
Characterisation according to ISO 10993-18 - Reminder and pre-test considerations
AET - (Analytical Evaluation Treshold) - Importance of validating the method
Types of data sought for the TRA.
Part 4 - Toxicological Risk Assessment
Toxicological Screening Limit (TSL)
Exposure (EEDmax)
Tolerable intake or contact (TI, TIcancer, TCL)
Calculation of MOS
Part 5 - Conclusion: Endpoint to be assessed
Part 6 - Q&A I Assessment of skills acquired through a final quiz
Methods used
The course is based around a presentation containing case studies and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt.
To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning.
Public
Audience
DM players responsible for toxicological risk analysis and biocompatibility assessment, quality managers, functions responsible for compiling technical documentation.
Prerequisites
General knowledge of issues relating to the biocompatibility of healthcare products, in particular ISO standards 10993-18, -12 and -1.
As this is not initial training, knowledge of the previous version of ISO 10993-17: 2002 and basic toxicology concepts is very important (threshold value, exposure dose, systemic vs. local toxicity, NOAEL/LOAEL, etc.).
Paul Fernandes
Biocompatibility toxicologist
La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION.
About CEHTRA
For 20 years we have specialised in assisting companies with the marketing of chemical substances and products in France, Europe and beyond.
Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products.
With a team of 70 people, we cover around ten sectors, including REACH, biocides, plant protection products, etc.