ISO-16061 › Instruments for use in association with non-active surgical implants - General requirements
The following bibliographic material is provided to assist you with your purchasing decision:
This document specifies the 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 supplied after refurbishment.
NOTE In this document, unless otherwise specified, the term "instrument" refers to an instrument for use in association with non-active surgical implants.
This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves.
With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.
This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.
To find similar documents by classification:
11.040.99 (Other medical equipment)
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:
ASTM-F88Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM-D4169
Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM-F1980
Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
Document Number
ISO 16061:2021
Revision Level
4TH EDITION
Status
Current
Publication Date
March 1, 2021
Committee Number
ISO/TC 150