BS EN ISO 19715:2017 pdf download

BS EN ISO 19715:2017 pdf download.BS EN ISO 19715:2017 pdf downloadv.
In dentistry, corresponding to their intended use, filling instruments come into contact with the patient. Consequently, special attention is to be given in respect to (re)processing.
Consideration of ergonomic aspects is also required. This is supported by the specific contra angle design.
BS EN ISO 19715 specifies requirements and test methods for a filling instrument with contra angle, which is used for the restoration of teeth via the application of polymer-based restorative materials and cements. It also specifies requirements for the design, dimensions and marking.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of BS EN ISO 19715. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1942 , Dentistry — Vocabulary
ISO 650 7-1 , Metallic materials — Vickers hardness test — Part 1: Test method
ISO 6508-1 , Metallic materials — Rockwell hardness test — Part 1: Test method
ISO 17664 , Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices
5 Requirements
5.1 Dimensions
The dimensions shown in Figure 8 are recommended dimensions for filling instruments with contra angle. Other dimensions may be used at the manufacturer’s discretion.
Single-ended filling instruments are also possible.
Test in accordance with 61.
Dimensions in millimetres
5.2 Dimensions of working end
Working ends of filling instruments with contra angles shall satisfy the dimensions indicated in Table 1 and Table 2.
The diameter for Type A shall be: mm. 0,8 mm, max. 3,5 mm.
The diameter for Type B shall be: mm. 0,8 mm, max. 2,5 mm.
The diameter for Type C shall be: mm. 0,8 mm, max. 2,5 mm.
The diameter for Type D shall be: mm 1,0 mm, max. 3,2 mm.
The diameter for Type E shall be: mm. 1,0 mm, max. 3,2 mm.
The material of both the handle and the working tip is at the manufacturer’s discretion provided that the requirements of this document are met. If stainless steel is the material of choice, examples of suitable steel types can be found in ISO 7153-1.
The stainless steel of the filling instrument shall have a hardness of 42 HRC to 60 HRC. Test in accordance with 6.2.
5.4 Surface finish
The working ends of the filling instrument shall be polished with a surlace roughness, R a. not exceeding 0,4 urn, except where otherwise designed. The surface can be gloss or matte, at the manufacturer’s discretion. All surfaces of the filling instrument shall be free of any surface defects and residues.
Coatings may be added to the working tip of metal filling instruments to increase lubricity and provide contrast in the oral cavity.
Test in accordance with 6.3.BS-EN-ISO-19715-2017

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