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Normas DIN – AENOR
DIN EN ISO 10993-10:2020-04

DIN EN ISO 10993-10:2020-04

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO/DIS 10993-10:2020); German and English version prEN ISO 10993-10:2020 / Note: Date of issue 2020-03-13*Intended as replacement for DIN EN ISO 10993-10 (2014-10).

Évaluation biologique des dispositifs médicaux - Partie 10: Essais de sensibilisation cutanée (ISO/DIS 10993-10:2020); Version allemande et anglaise prEN ISO 10993-10:2020 / Attention: Date de parution 2020-03-13*Prévu pour remplacer DIN EN ISO 10993-10 (2014-10).

Biologische Beurteilung von Medizinprodukten - Teil 10: Prüfungen auf Hautsensibilisierung (ISO/DIS 10993-10:2020); Deutsche und Englische Fassung prEN ISO 10993-10:2020 / Achtung: Erscheinungsdatum 2020-03-13*Vorgesehen als Ersatz für DIN EN ISO 10993-10 (2014-10).

Fecha:
2020-04 /Active
Equivalencias internacionales:

ISO/DIS 10993-10 (2020-02)

prEN ISO 10993-10 (2020-02)

Resumen:
This part of ISO 10993 assesses possible contact hazards from chemicals released from medical devices, which may produce skin sensitization. Some materials that are included in medical devices have been tested, and their skin sensitization potential has been documented. Other materials and their chemical components have not been tested and may induce adverse effects when in contact with human tissue.
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, Materials, Medical devices, Medical equipment, Medical products, Methods, Observation, Planning, Rabbits, Samples, Selection, Sensitization, Side effects, Skin (body), Skin contact, Substances, Surgical equipment, Surgical implants, Test animals, Test performance, Testing, Trials
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