SK EN ISO 16061:2016

Instrumente për përdorim me implantet kirurgjikale jo aktive - Kërkesa të përgjithshme (ISO 16061:2015)

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

Asnjë informacion i shtuar.

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.

SK EN ISO 16061:2017 replaces SK EN ISO 16061:2016 - 2016-07-22