DIN EN ISO 10993-6:2007-08

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007); German version EN ISO 10993-6:2007 / Note: A transition period, as set out in DIN EN ISO 10993-6 (2009-08), exists until 2010-03-21.

Évaluation biologique des dispositifs médicaux - Partie 6: Essais concernant les effets locaux après implantation (ISO 10993-6:2007); Version allemande EN ISO 10993-6:2007 / Attention: Il existe un délai de transition comme fixé en DIN EN ISO 10993-6 (2009-08) jusqu'à 2010-03-21.

Biologische Beurteilung von Medizinprodukten - Teil 6: Prüfungen auf lokale Effekte nach Implantation (ISO 10993-6:2007); Deutsche Fassung EN ISO 10993-6:2007 / Achtung: Übergangsfrist, festgelegt durch DIN EN ISO 10993-6 (2009-08), bis 2010-03-21 beachten.

Información:

Fecha Anulación:

2019-08 /Withdrawn

ICS:

11.100.20 - Biological evaluation of medical devices

Equivalencias internacionales:

EN ISO 10993-6 (2007-04)

ISO 10993-6 (2007-04)

Relación con otras normas DIN:

Reemplaza a: DIN EN ISO 10993-6:2005-04

Reemplazada por: DIN EN ISO 10993-6:2009-08

Reemplaza a: DIN EN 30993-6:1994-12

Resumen:

This part of the ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended to be used in medical devices. The standard applies to solid biomaterials that are non-degradable, degradable and/or resorbable, non-solid biomaterials, such as porous materials, and liquids, pastes and particulates.

Keywords:

Bioassay, Biocompatibility, Biological, Biological analysis and testing, Biological hazards, Biological tests, CE marking, Ceramics, Compatibility, Definitions, Dental equipment, Dental materials, Dentistry, Determination, Evaluations, Experimental animals, Fabrics, Fine mechanics, Histology, Implantation test, Implants (surgical), Macroscopic, Materials, Medical devices, Medical equipment, Medical instruments, Medical products, Medical sciences, Methods, Muscles, Observation, Polymers, Preparation (medical), Principle, Production, Reaction, Samples, Scope, Solids, Surgery, Surgical equipment, Surgical implants, Taking-out, Test duration, Test pieces, Testing

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