BS EN ISO 28158:2018,Dentistry — Integrated dental floss and handles.BS EN ISO 28158:2018 pdf free download.
BS EN ISO 28158:2018 specifies the requirements and test methods for integrated dental floss and handles used for home care, community care, professional care of oral health or a part of dental treatment.
BS EN ISO 28158:2018 is applicable to integrated dental floss and handles for manual use. It does not include dental floss and handles which contain a continuous supply of dental floss, or handles to which the floss is subsequently added.
BS EN ISO 28158:2018 excludes specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological risks. For assessment of such biological risks, see ISO 10993-1 and ISO 7405.
2 Normative references
ISO 1942, Dentistry-Vocabulary;
ISO 3696:1987, Water for analytical laboratory use-Specification and test methods;
4.1 Material and shape
4.1.1 Material
The dental floss and handle shall be free from extraneous matter when examined according to 6.2 a).
Materials intentionally added to dental floss or handle such as wax, pigments or flavouring agents, shall be considered as part of the device.
4.1.2 Shape
The integrated dental floss and handle shall not have any sharp surface, burr or parts when examined according to 6.2 b),except when a part, if included, is designed and intended to be used as a tooth pick.