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Publication date

August 2009

Number of pages

37 p.

Reference

NF EN ISO 10993-17

ICS Codes

11.040.01 Medical equipment in general

11.100.20 Biological evaluation of medical devices

Classification index

S99-501-17

Print number

1 - 20/07/2009

International kinship

ISO 10993-17:2002

European kinship

EN ISO 10993-17:2009

Sumary

Biological evaluation of medical devices - Part 17 : Establishment of allowable limits for leachable substances

ISO 10993-17:2002 specifies the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.

ISO 10993-17:2002 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).

Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. ISO 10993-17:2002 does not address the potential for exposure from such sources.

Replaced standards (1)

NF EN ISO 10993-17

June 2003

Standard Cancelled

Biological evaluation of medical devices - Part 17 : establishment of allowable limits for leachable substances

ISO 10993-17:2002 specifies the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. ISO 10993-17:2002 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices). Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. ISO 10993-17:2002 does not address the potential for exposure from such sources.

Standard replaced by (1)

NF EN ISO 10993-17

November 2023

Standard Current

Biological evaluation of medical devices - Part 17 : toxicological risk assessment of medical device constituents

This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is without appreciable harm are also specified. The toxicological risk assessment can be part of the biological evaluation of the final product, as described in ISO 10993-1. The process described in this document applies to chemical characterization information obtained in line with ISO 10993-18. When a toxicological risk assessment of either the compositional information or analytical chemistry data (e.g. extractable data or leachable data) are required to determine whether the toxicological risks related to the constituents are negligible or tolerable. The process described in this document 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 in or extracted from a medical device at an amount representative of patient exposure below a relevant, toxicologically-based reporting threshold (see applicable requirements in ISO 10993-18:2020, Annex E and ISO/TS 21726); — a new or changed medical device for which chemical or biological equivalence has been established with an existing biocompatible or clinically established medical device (see applicable requirements in ISO 10993-18:2020, Annex C). The process described in this document is also not applicable to: — medical device constituents that do not contact the body (e.g. in vitro diagnostics); — biological risks associated with physical interactions of the medical device with the body (i.e. application of mechanical forces, energy or surface morphology, etc.), provided that the chemical exposure is not changed; — active pharmaceutical ingredients of device-drug combination products or biologic components of device-biologic combination products as additional regulatory considerations can apply; — exposure to a particular constituent that arises from sources other than the device, such as food, water or air.

Table of contents

View the extract

Avant-propos
iv
Introduction
vi
1 Domaine d'application
1
2 Référence normative
1
3 Termes et définitions
1
4 Principes généraux
5
5 Détermination des prises tolérables (PT) pour des substances relargables spécifiques
7
5.1 Généralités
7
5.2 Considérations d'exposition pour le calcul des PT
7
5.3 Collecte et évaluation des données
8
5.4 Détermination de la PT pour les seuils critiques de substances ne provoquant pas de cancer
9
5.5 Détermination de la PT pour les seuils critiques de substances provoquant le cancer
11
5.6 Détermination des niveaux de contact tolérables (NCT)
12
5.7 Évaluation des risques dus aux mélanges
14
6 Calcul de l'exposition tolérable (ET)
14
6.1 Généralités
14
6.2 Population exposée
15
6.3 Calcul du coefficient d'utilisation à partir des conditions d'utilisation prévues
15
6.4 Exposition tolérable
17
7 Étude de faisabilité
17
8 Évaluation du bénéfice
18
9 Limites admissibles
18
10 Exigences de rapport
18
Annexe A (informative) Hypothèses types pour les paramètres biologiques
19
Annexe B (informative) Évaluation des risques pour les mélanges des substances relargables
22
Annexe C (informative) Conversion des limites admissibles relatives à l'exposition systémique et au contact de la surface du corps en dose maximale pour le patient provenant d'un dispositif médical
23
Annexe D (informative) Rapport d'analyse des risques
25
Bibliographie
26

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