ISO 16061:2008

Instrumentation for use in association with non-active surgical implants -- General requirements
Autor: ISO
Código ICS: 11.040.40
No Vigente
$192.780

Alcance

ISO 16061:2008 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.ISO 16061:2008 also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.With regard to safety, ISO 16061:2008 gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.

Especificaciones de la Norma
Fecha de Publicación 25/11/2008
Título Secundario Instrumentation à utiliser en association avec les implants chirurgicaux non actifs -- Exigences générales
Páginas Técnicas 19
Idioma Inglés