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Normas DIN – AENOR
DIN EN ISO 10993-11/A1:2009-02

DIN EN ISO 10993-11/A1:2009-02

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006); English version prEN ISO 10993-11:2008, Amendment 1 / Note: Date of issue 2009-02-16

Évaluation biologique des dispositifs médicaux - Partie 11: Essais de toxicité systémique (ISO 10993-11:2006); Version anglaise prEN ISO 10993-11:2008, Amendement 1 / Attention: Date de parution 2009-02-16

Biologische Beurteilung von Medizinprodukten - Teil 11: Prüfungen auf systemische Toxizität (ISO 10993-11:2006); Englische Fassung prEN ISO 10993-11:2008, Änderung 1 / Achtung: Erscheinungsdatum 2009-02-16

Fecha Anulación:
2019-08 /Withdrawn
Equivalencias internacionales:

prEN ISO 10993-11 (2008-12)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 10993-11:2009-08

Resumen:
This standard addresses the evaluation of generalized systemic toxicity, not specific target organ or organ system toxicity, even though these effects may result from the systemic absorption and distribution of toxicants. Because of the broad range of medical devices, and their materials and intended uses, this standard is not overly prescriptive. While it addresses specific methodological aspects to be considered in the design of systemic toxicity tests, proper study design must be uniquely tailored to the nature of the device's materials and its intended clinical application. Other elements of this standard are prescriptive in nature, including those aspects that address compliance with good laboratory practices and elements for inclusion in reporting.
Keywords:
Abbreviated description, Animal husbandry, Bioassay, Biological, Biological analysis and testing, Biological hazards, Biological tests, Cloth, Conditions, Dental equipment, Dental materials, Design, Determination, Dosage, Dose, English language, 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, Toxicity, Validation
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