SS-EN-ISO-16061 › Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
Show Complete Document History
The following bibliographic material is provided to assist you with your purchasing decision:
This International Standard 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.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, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the manufacturer. This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.
To find similar documents by classification:
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
SS-EN ISO 16061:2015
May 25, 2015
EN ISO 16061:2015(IDT); ISO 16061:2015(IDT)