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This International Standard specifies requirements and test methods for wires to be used in fixed and removable orthodontic appliances. It includes preformed orthodontic archwires but excludes springs and other preformed components. This International Standard gives detailed requirements concerning the presentation of the physical and mechanical properties of orthodontic wires, the test methods by which they can be determined, packaging, and labelling information. Specified qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard but it is recommended that to assess possible biological or toxicological hazards, reference should be made to ISO 7405 and ISO 10993-1.