95.99 Withdrawal of Standard May 11, 2015
ISO
ISO/TC 150 Implants for surgery
International Standard
11.040.40 Implants for surgery, prosthetics and orthotics | 11.040.99 Other medical equipment
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.
WITHDRAWN
ISO 16061:2000
WITHDRAWN
ISO 16061:2008
95.99
Withdrawal of Standard
May 11, 2015
ABANDON
ISO 16061:2008/NP Amd 1
WITHDRAWN
ISO 16061:2015