This standard has been reviewed* and then confirmed in 2011.
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.
Edition: 2 (Monolingual) ICS: 11.040.99; 11.040.40 Status: Published Stage: 90.92 (2012-05-10) TC/SC: ISO/TC 150 Number of Pages: 19
Revised by: ISO/DIS 16061
Revises: ISO 16061:2000
No corrigenda or amendments available