ISO 19023:2018 PDF

Scope: This document specifies requirements and test methods for orthodontic anchor screws used in orthodontic treatment. This document gives details of methods to compare physical and mechanical properties of orthodontic anchor screws together with test methods and packaging and labelling information. NOTE Orthodontic anchor screws are used to provide temporary intraoral skeletal anchorage during orthodontic treatment and are removed at the end of the orthodontic treatment. Similar to endosseous dental implants, they are, therefore inserted into the maxillo-facial bone structures.

ISO 19023:2018 Referenced Document

ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)*， 2024-04-20 Update
ASTM F1839-08 Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopedic Devices and Instruments*， 2024-04-20 Update
ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws
ASTM F67-13 Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)*， 2024-04-20 Update
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 16443:2014 Dentistry - Vocabulary for dental implants systems and related procedure
ISO 1942:2009 Dentistry - Vocabulary
ISO 5832-2:1999 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
ISO 5832-3:2016 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
ISO 8601:2004 Data elements and interchange formats - Information interchange - Representation of dates and times