Home

ISO 16061:2008
Subscribe to updates

Instrumentation for use in association with non-active surgical implants -- General requirements

This standard has been revised by: ISO 16061:2015

Abstract

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 standards

Got a question?

Check out our FAQs

Email customer services
or call us on +41 22 749 08 88
09:00 – 12:30, 14:00 – 17:00 (UTC+1).