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Normas DIN – AENOR
DIN EN ISO 10993-11:1995-12

DIN EN ISO 10993-11:1995-12

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:1993); German version EN ISO 10993-11:1995

Evaluation biologiques des dispositifs médicaux - Partie 11: Essais de toxicité systémique (ISO 10993-11:1993); version allemande EN ISO 10993-11:1995

Biologische Beurteilung von Medizinprodukten - Teil 11: Prüfungen auf systemische Toxizität (ISO 10993-11:1993); Deutsche Fassung EN ISO 10993-11:1995

Fecha Anulación:
2016-11 /Withdrawn
Equivalencias internacionales:

EN ISO 10993-11 (1995-11)

ISO 10993-11 (1993-12)

SN EN ISO 10993-11 (1996)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 10993-11:2006-11

Resumen:
The document specifies methodologies for the evaluation of the systemic toxicity potential of medical devices which release constituents into the body. In addition, it includes pyrogenicity testing.
Das Dokument legt Methodologien zur Beurteilung der möglichen systemischen Toxizität von Medizinprodukten fest, die Bestandteile im Körper freisetzen. Zusätzlich ist eine Prüfung auf Pyrogenität enthalten.
Keywords:
Abbreviated description, Bioassay, Biological, Biological analysis and testing, Biological hazards, Biological tests, Cloth, Conditions, Definitions, Dental equipment, Dental materials, Design, Determination, Evaluations, Extraction, Health protection, Implants (surgical), Information, Inhalation, Limits (mathematics), Measurement, Medical devices, Medical equipment, Medical products, Methods, Methods of analysis, Preparation, Production, Quality assurance, Quality assurance systems, Recommendation, Residual content, Residue, Residues, Samples, Selection, Specification (approval), Specimen preparation, Status, Sterilization (hygiene), Surgical equipment, Surgical implants, Testing, Tests, Toxicity, Validation
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