1.212.642.4980     info@ansi.org    8:30am – 6pm EST, Monday – Friday
ANSI Standards Store

Browse ISO Standards
Browse IEC Standards

View all Publishers





View All Standards Packages



Search tips Search tips

ISO 16061:2015 Plus Redline

     

Instrumentation for use in association with non-active surgical implants - General requirements (includes Redline Version)

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.


Need more than one copy or have multiple people needing access,
an ANSI Site License Subscription may be the perfect solution.

Would you like to Email to a friend? If you would like to Email a friend a link to this item please    Login

Questions?