Home

Subscribe to updates

ISO 16061:2008

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

This standard has been reviewed and then confirmed in 2011 
More information

ISO standards are reviewed every five years

Close

Media and price

Format Price Language
PDF CHF 118,00 Add to basket
Paper CHF 118,00 Add to basket

 

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.

 

Preview and follow ISO 16061:2008 on our Online Browsing Platform

Preview


Contact customer services

Send your enquiry by email
or call us on +41 22 749 08 88
09:00 – 12:30, 14:00 – 17:00 (UTC+1).

Related standards

Standards in the same category (11.040.99)
Standards in the same category (11.040.40)
Standards from the same committee