NF EN ISO 10993-1
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Biological evaluation of medical devices - Part 1 : evaluation and testing within a risk management system process
ISO 10993-1:2009 describes: the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of devices based on the nature and duration of their contact with the body; the evaluation of existing relevant data from all sources; the identification of gaps in the available data set on the basis of a risk analysis; the identification of additional data sets necessary to analyse the biological safety of the medical device; the assessment of the biological safety of the medical device.
ISO 10993-1:2009 describes:
- the general principles governing the biological evaluation of medical devices within a risk management process;
- the general categorization of devices based on the nature and duration of their contact with the body;
- the evaluation of existing relevant data from all sources;
- the identification of gaps in the available data set on the basis of a risk analysis;
- the identification of additional data sets necessary to analyse the biological safety of the medical device;
- the assessment of the biological safety of the medical device.
<p>This document specifies:</p> <p>— the general principles governing the biological evaluation of medical devices within a risk management process;</p> <p>— the general categorization of medical devices based on the nature and duration of their contact with the body;</p> <p>— the evaluation of existing relevant data from all sources;</p> <p>— the identification of gaps in the available data set on the basis of a risk analysis;</p> <p>— the identification of additional data sets necessary to analyse the biological safety of the medical device;</p> <p>— the assessment of the biological safety of the medical device.</p> <p>This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: </p> <p>— the patient's body during intended use;</p> <p>— the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others). </p> <p>This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.</p> <p>This document also gives guidelines for the assessment of biological hazards arising from:</p> <p>— risks, such as changes to the medical device over time, as a part of the overall biological safety assessment;</p> <p>— breakage of a medical device or medical device component which exposes body tissue to new or novel materials. </p> <p>Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing.</p> <p>This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.</p>
- Avant-proposiv
- IntroductionVI
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1 Domaine d'application1
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2 Références normatives1
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3 Termes et définitions2
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4 Principes généraux applicables à l'évaluation biologique des dispositifs médicaux4
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5 Classification des dispositifs médicaux7
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5.1 Généralités7
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5.2 Classification suivant la nature du contact avec le corps du patient7
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5.3 Classification suivant la durée du contact9
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6 Processus d'évaluation biologique9
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6.1 Caractérisation de matériau9
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6.2 Essais d'évaluation biologique10
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7 Interprétation des données d'évaluation biologique et estimation biologique globale de sécurité15
- Annexe A (informative) Essais d'évaluation biologique16
- Annexe B (informative) Directives concernant le processus de gestion du risque17
- Annexe C (informative) Processus suggéré de revue de littérature scientifique20
- Bibliographie22
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