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Normas DIN – AENOR
DIN EN ISO 10993-10:2008-08

DIN EN ISO 10993-10:2008-08

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO/DIS 10993-10:2008); German version prEN ISO 10993-10:2008 / Note: Date of issue 2008-09-01

Évaluation biologique des dispositifs médicaux - Partie 10: Essais d'irritation et sensibilisation de peau (ISO/DIS 10993-10:2008); Version allemande prEN ISO 10993-10:2008 / Attention: Date de parution 2008-09-01

Biologische Beurteilung von Medizinprodukten - Teil 10: Prüfungen auf Irritation und Hautsensibilisierung (ISO/DIS 10993-10:2008); Deutsche Fassung prEN ISO 10993-10:2008 / Achtung: Erscheinungsdatum 2008-09-01

Fecha Anulación:
2010-12 /Withdrawn
Equivalencias internacionales:

ISO/DIS 10993-10 (2008-08)

prEN ISO 10993-10 (2008-08)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 10993-10:2010-12

Resumen:
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This part of ISO 10993 includes: a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; b) details of in vivo (irritation and sensitization) test procedures, and; c) key factors for the interpretation of the results. Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.
Keywords:
Allergies, Animals, Bioassay, Biological, Biological analysis and testing, Biological hazards, Biological tests, Chemicals, Classification, Deceleration, Definitions, Dental equipment, Dentistry, Determinations of susceptibility, Evaluations, Eyes, In vitro, In vivo, Information, Instruments, Layout, Mass, Materials, Medical devices, Medical equipment, Medical products, Methods, Observation, Planning, Principle, Rabbits, Samples, Selection, Sensitization, Side effects, Skin (body), Skin contact, Surgical equipment, Surgical implants, Test animals, Test performance, Testing, Trials
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