EN ISO 10993-17:2023 | Toxicological risk assessment of medical device constituents
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EN ISO 10993-17:2023 | Toxicological risk assessment of medical device constituents
ID 20935 | 10.12.2023 / Preview attached
EN ISO 10993-17:2023 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
ISO 10993-17 specifies the process and requirements for the toxicological risk assessment of medical device constituents to be used within the biological evaluation of the final product (described in ISO 10993-1). It includes the methods and criteria used to assess if exposure to a chemical constituent is without appreciable harm.
The process described in this standard is intended to apply after chemical characterization compositional profiling is performed as required by ISO 10993-18, and thus a toxicological risk assessment of either the compositional information, extractable data or leachable data is required to conclude if the risks related to the constituents are acceptable or not.
The process described in ISO 10993-17 is not intended to apply to circumstances where the toxicological risk has been estimated by other means, such as:
- constituents, excluding cohort of concern or excluded chemicals, that are present or extracted at an amount representative of patient exposure below a relevant, toxicologically-based reporting threshold.
- a new or changed medical device for which chemical or biological equivalence has been established with an existing biocompatible or clinically established medical device.
The process described in ISO 10993-17 is also not applicable to:
- medical device constituents that do not contact the body,
- all biological risks applicable to a medical device provided that the chemical exposure is unchanged,
- active pharmaceutical ingredients of device-drug combination products or biologic components of device-biologic combination products as additional regulatory considerations may apply,
- exposure to a particular chemical constituent that arises from sources other than the device, such as food, water, or air.
The text of ISO 10993-17:2023 has been approved in Europe as EN ISO 10993-17:2023 without any changes.
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Le novità della norma EN ISO 10993-17:2023
La EN ISO 10993-17:2023 presenta una nuova sezione sull’uso di un limite di screening tossicologico (Tsl) per i costituenti chimici che aiuta i valutatori del rischio a restringere il campo dei costituenti che richiedono una valutazione. Inoltre, il nuovo standard fornisce criteri di accettazione del rischio per valutare il margine di sicurezza (margin of safety, MoS) per ciascun componente. Lo standard chiarisce, infine, gli scenari di rischio in cui è raccomandata una valutazione del rischio tossicologico e delinea metodi alternativi di mitigazione del potenziale danno.
Dopo un’attenta caratterizzazione chimica e una valutazione del rischio tossicologico, si prosegue con la valutazione degli endpoint (e.g. irritazione; sensitizzazione; tossicità acuta) per esaminare la biocompatibilità del dispositivo.
Fonte: ISO
Collegati
UNI CEI EN ISO 14971:2022 - Gestione dei rischi dispositivi medici
Regolamento (UE) 2017/745
Regolamento (UE) 2017/746
Regolamento (UE) 2017/745
Regolamento (UE) 2017/746
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