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Normas DIN – AENOR
DIN EN ISO 10993-12/A1:2009-02

DIN EN ISO 10993-12/A1:2009-02

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007); English version prEN ISO 10993-12:2008, Amendment 1 / Note: Date of issue 2009-02-16

Évaluation biologique des dispositifs médicaux - Partie 12: Préparation des échantillons et matériaux de référence (ISO 10993-12:2007); Version anglaise prEN ISO 10993-12:2008, Amendement 1 / Attention: Date de parution 2009-02-16

Biologische Beurteilung von Medizinprodukten - Teil 12: Proben-vorbereitung und Referenzmaterialien (ISO 10993-12:2007); Englische Fassung prEN ISO 10993-12:2008, Änderung 1 / Achtung: Erscheinungsdatum 2009-02-16

Fecha Anulación:
2019-08 /Withdrawn
Equivalencias internacionales:

prEN ISO 10993-12 (2008-12)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 10993-12:2009-08

Resumen:
This standard specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical devices testing in biological systems in accordance with one or more parts of the ISO 10993 series. Specifically this part addresses: test material selection; selection of representative portions from a device; test sample preparation; experimental controls; selection of and requirements for reference materials; and, preparation of extracts. The applicability of this standard to absorbable materials, materials that polymerize in-situ, tissue engineered medical products and materials of biological origin should be carefully evaluated.
Keywords:
Bioassay, Biological, Biological tests, Certification, Checks, Conditions, Cytotoxicity, Dental equipment, Dental instruments, English language, Evaluations, Extraction, Extracts, Implants (surgical), Materials, Medical devices, Medical equipment, Medical products, Particles, Patterns, Preparation, Production, Reference materials, References, Samples, Selection, Specification (approval), Specimen preparation, Standards, Surfaces, Surgical equipment, Surgical implants, Surgical instruments, Temperature, Testing
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