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National standards and national normative documents

Publication date

June 2003

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

S99-517

Print number

1 - 18/06/2003

International kinship

ISO 10993-17:2002

European kinship

EN ISO 10993-17:2002

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.

Standard replaced by (1)

NF EN ISO 10993-17

August 2009

Standard Current

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.

Table of contents

Avant-propos
iv
Introduction
vi
Domaine d'application
2
Référence normative
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) 1 4
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 1 8
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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