SSH EN ISO 16061:2009

Instrumentet që përdoren së bashklu me implantet e kirurgjisë jo aktive - Kërkesa të përgjithshme (ISO 16061:2008, Versioni i korrigjuar 2009-03-15)

Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15)

Scope

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.

Related directives

Directives related to this standards.