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Normas DIN – AENOR
DIN EN ISO 10993-17:2009-08

DIN EN ISO 10993-17:2009-08

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002); German version EN ISO 10993-17:2009 / Note: DIN EN ISO 10993-17 (2003-06) remains valid alongside this standard until 2010-03-21.

Évaluation biologique des dispositifs médicaux - Partie 17: Établissement des limites admissibles des substances relargables (ISO 10993-17:2002); Version allemande EN ISO 10993-17:2009 / Attention: DIN EN ISO 10993-17 (2003-06) reste valable avec la présente norme jusqu'à 2010-03-21.

Biologische Beurteilung von Medizinprodukten - Teil 17: Nachweis zulässiger Grenzwerte für herauslösbare Bestandteile (ISO 10993-17:2002); Deutsche Fassung EN ISO 10993-17:2009 / Achtung: Daneben gilt DIN EN ISO 10993-17 (2003-06) noch bis 2010-03-21.

Fecha:
2019-08 /Active
Equivalencias internacionales:

EN ISO 10993-17 (2009-04)

ISO 10993-17 (2002-12)

TS EN ISO 10993-17 (2013-02-21)

Relación con otras normas DIN:
Resumen:
This part of ISO 10993 specifies the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. This part of ISO 10993 is not applicable to devices that have no patient contact (e. g. in vitro diagnostic devices).
Keywords:
Allowable, Alloys, Bioassay, Biological analysis and testing, Biological tests, CE marking, Decomposition, Decomposition products, Definitions, Degradability, Degradation, Deterioration, Determination, Establishment, Evaluations, Health hazards, Identification, Limits (mathematics), Medical devices, Medical equipment, Medical products, Metals, Methods, Quantification, Residues, Risk analysis, Soluble, Testing, Toxicological testing
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