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Normas DIN – AENOR
DIN EN ISO 10993-7:2006-11

DIN EN ISO 10993-7:2006-11

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2006); German version prEN ISO 10993-7:2006

Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène (ISO/DIS 10993-7:2006); Version allemande prEN ISO 10993-7:2006

Biologische Beurteilung von Medizinprodukten - Teil 7: Ethylenoxid-Sterilisationsrückstände (ISO/DIS 10993-7:2006); Deutsche Fassung prEN ISO 10993-7:2006

Fecha Anulación:
2019-02 /Withdrawn
Equivalencias internacionales:

ISO/DIS 10993-7 (2006-02)

prEN ISO 10993-7 (2006-02)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 10993-7:2009-02

Resumen:
This part of ISO describes the general principles governing the biological evaluation and medical devices, the categorization of devices based on the the nature and duration of their contact with the body and the selection of appropriate tests. This part of ISO does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure.
Keywords:
Acetone, Analysis, Balances, Bioassay, Biological, Biological analysis and testing, Biological tests, Categories, Chemical residues, Clearing, Composition, Contact, Data, Definitions, Dental equipment, Equipment, Ethylene oxide, Evaluations, Extraction, Filters, Fire pumps, Fluctuation, Fume cupboards, Furnaces, Gas chromatography, Gaseous, Handling, Health protection, Laboratories, Limits (mathematics), Liquids, Materials, Measurement, Medical devices, Medical equipment, Medical products, Medical sciences, Methods, Methods of analysis, Packages, Precision, Production, Products, Quality assurance, Quality assurance systems, Reagents, Refrigerators, Residual content, Residue, Residues, Safety, Samples, Solvents, Specification (approval), Stability, Standards, Sterile technology, Sterilization (hygiene), Sterilizing gases, Surgical equipment, Surgical implants, Surgical instruments, Surveillance (approval), Symbols, Testing, Validation, Valves, Ventilation
158,04
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