This International Standard specifies general requirements for instruments to be used in association with nonactive surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.This International Standard 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, this International Standard gives requirements for intended performance, designattributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.This I
DS/EN ISO 16061:2009 history
2009DS/EN ISO 16061:2009 Instrumentation for use in association with non-active surgical implants - General requirements