New ISO 10993-17 : 2023 - General and new features

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New ISO 10993-17 : 2023 - General and new features

Objectifs.

Understand the methodology for the toxicological assessment of medical device components in accordance with ISO 10993-17:2023.

Place	Horaire	Price	Language	Access time
	7 hours	from 690€ (HT)	French	2 months

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Objectifs.

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

Méthodes mobilisées.

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.

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Audience.

DM players responsible for toxicological risk analysis and biocompatibility assessment, quality managers, functions responsible for compiling technical documentation.

Prérequis.

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.).

Parole de nos clients

« Je suis très satisfaite de cette formation bien adaptée à mon background et qui a bien répondu à mes besoins. Par ailleurs, le format à distance est entièrement satisfaisant, et nombre de stagiaires limité facilite les échanges. »

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A propos de CEHTRA

Nous sommes spécialisés depuis 20 ans dans l'accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France mais aussi en Europe et hors Europe.

Nos toxicologues, écotoxicologues et chimistes vous apportent leur expertise pour assurer la conformité réglementaire de vos produits.

Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires, etc...