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Normas DIN – AENOR
DIN EN ISO 10993-23:2019-08

DIN EN ISO 10993-23:2019-08

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO/DIS 10993-23:2019); German and English version prEN ISO 10993-23:2019 / Note: Date of issue 2019-07-05

Évaluation biologique des dispositifs médicaux - Partie 23: Tests d'irritation (ISO/DIS 10993-23:2019); Version allemande et anglaise prEN ISO 10993-23:2019 / Attention: Date de parution 2019-07-05

Biologische Beurteilung von Medizinprodukten - Teil 23: Prüfungen auf Irritation (ISO/DIS 10993-23:2019); Deutsche und Englische Fassung prEN ISO 10993-23:2019 / Achtung: Erscheinungsdatum 2019-07-05

Fecha:
2019-08 /Active
Equivalencias internacionales:

ISO/DIS 10993-23 (2019-05)

prEN ISO 10993-23 (2019-05)

Resumen:
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993-1 and ISO 10993-12.
Keywords:
Biological, Biological tests, Checks, Chemical composition, Conditions, Cytotoxicity, Definitions, Dental equipment, Dental instruments, Evaluations, Extracts, Implants (surgical), In vitro, In vivo, Interpretations, Irritant effect, Irritants, Irritation, Materials, Medical devices, Medical equipment, Medical products, Particles, Patterns, Production, Selection, Skin (body), Specification (approval), Surfaces, Surgical equipment, Surgical implants, Surgical instruments, Testing
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