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Normas DIN – AENOR
DIN EN ISO 10993-12:2005-03

DIN EN ISO 10993-12:2005-03

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2002); German version EN ISO 10993-12:2004

Évaluation biologique des dispositifs médicaux - Partie 12: Préparation des échantillons et matériaux de référence (ISO 10993-12:2002); Version allemande EN ISO 10993-12:2004

Biologische Beurteilung von Medizinprodukten - Teil 12: Probenvorbereitung und Referenzmaterialien (ISO 10993-12:2002); Deutsche Fassung EN ISO 10993-12:2004

Fecha Anulación:
2018-02 /Withdrawn
Equivalencias internacionales:

EN ISO 10993-12 (2004-11)

ISO 10993-12 (2002-12)

Relación con otras normas DIN:
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, Definitions, Dental equipment, Dental instruments, 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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