NF EN ISO 10993-17

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.

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Main informations

Collections

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

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

Table of contents
View the extract
  • 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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