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现行 EN ISO 3990:2023
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Dentistry - Evaluation of antibacterial activity of dental restorative materials, luting materials, fissure sealants and orthodontic bonding or luting materials (ISO 3990:2023) 牙科学.牙科修复材料 粘接剂 裂缝密封剂和正畸粘接或粘接剂的抗菌活性评估(ISO/DIS 3990-2022)
发布日期: 2023-07-19
实施日期: 2023-07-19
本文件规定了评估牙科修复材料的试验方法,这些材料由各自的制造商声称具有“抗菌”效果。 本文件不包括灭菌或消毒程序有效性的测试,也不得用于证明牙科医疗器械没有微生物污染。
This document specifies test methods for the evaluation of dental restorative materials, luting materials, fissure sealants and orthodontic bonding or luting materials that are claimed by their respective manufacturers to exert “antibacterial” effects. NOTE       Materials for pulp capping (e.g. calcium hydroxide formulations), endodontic filling materials, dental implants or implant systems, nightguards and additive manufactured (e.g. 3D-printed) materials are not covered in this document. This document does not cover tests on the effectiveness of sterilization or disinfection procedures. This document cannot be used to demonstrate a lack of microbial contamination of medical devices used in dentistry.
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归口单位: CEN/TC 55
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