NF EN ISO 10993-12
Biological evaluation of medical devices - Part 12 : sample preparation and reference materials
ISO 10993-12:2007 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of the ISO 10993 series. Specifically ISO 10993-12:2007 addresses: test sample selection;selection of representative portions from a device;test sample preparation;experimental controls;selection of and requirements for reference materials;preparation of extracts. ISO 10993-12:2007 is not applicable to materials or devices containing live cells.
ISO 10993-12:2007 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of the ISO 10993 series. Specifically ISO 10993-12:2007 addresses:
- test sample selection;
- selection of representative portions from a device;
- test sample preparation;
- experimental controls;
- selection of and requirements for reference materials;
- preparation of extracts.
ISO 10993-12:2007 is not applicable to materials or devices containing live cells.
<p>ISO 10993-12:2012 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993. Specifically, ISO 10993-12:2012 addresses the following:</p> <ul> <li>test sample selection;</li> <li>selection of representative portions from a device;</li> <li>test sample preparation;</li> <li>experimental controls;</li> <li>selection of, and requirements for, reference materials;</li> <li>preparation of extracts.</li> </ul> <p>ISO 10993-12:2012 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.</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 définitions1
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4 Exigences générales3
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5 Matériaux de référence4
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5.1 Généralités4
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5.2 Certification des matériaux de référence pour les essais de sécurité biologique4
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6 Utilisation des matériaux de référence comme contrôles expérimentaux5
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7 Choix des échantillons5
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8 Préparation des échantillons et des matériaux de référence5
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9 Choix des parties représentatives d'un dispositif6
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10 Préparation d'extraits d'échantillons d'essai6
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10.1 Généralités6
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10.2 Récipients utilisés pour l'extraction6
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10.3 Conditions et méthodes d'extraction7
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10.4 Conditions d'extraction pour l'identification et l'estimation des risques dans des conditions d'utilisation exagérées9
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11 Rapport d'essai10
- Annexe A (informative) Contrôles expérimentaux11
- Annexe B (informative) Principes généraux et informations pratiques sur la préparation et le choix des échantillons13
- Annexe C (informative) Principes d'extraction de l'échantillon15
- Bibliographie18
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