95.99 Withdrawal of Standard Mar 15, 2021
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 16061:2015 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.
WITHDRAWN
ISO 16061:2008
WITHDRAWN
ISO 16061:2015
95.99
Withdrawal of Standard
Mar 15, 2021
PUBLISHED
ISO 16061:2021