ISO 15606 pdf download.Dental handpieces — Air-powered scalers and scaler tips
1 Scope
This International Standard specifies requirements and tests methods for dental air-powered scalers and scaler tips, operated by connection to dental units, for use on patients. It also contains specifications concerning manufacturers’ instructions, marking and packaging.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 1 942-3, Dental vocabulary — Part 3: Dental instruments. ISO 7000, Graphical symbols for use on equipment — Index and synopsis. ISO 91 68, Dental handpieces — Hose connectors. ISO 9687, Dental equipment — Graphical symbols. ISO 1 3402:1 995, Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure. ISO/TR 1 5223, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. IEC 60601 -1 :1 988, Medical electrical equipment — Part 1 : General requirements for safety. IEC 60651 , Sound level meters.
3 Terms and definitions
For the purposes of this International Standard, the terms and definitions given in ISO 1 942-3 and the following apply. 3.1 scaler tip fixed or interchangeable dental instrument used in an air-powered scaler and consisting of a shaft and a working part for dental procedures of air scaling
4 Requirements and recommendations
4.1 General design 4.1.1 General Dental air-powered scalers should be comfortable for the operator to use and easy to manipulate. The outside surface of the scaler should be easy to clean, and particular attention should be given to providing secure gripping surfaces for operator manipulation. In order to reduce glare, highly polished surfaces should be avoided. Dental air-powered scalers normally comprise a handpiece into which scaler tips are interchangeably inserted. Internal parts should be designed in such a way that either penetration of liquids or particles is impossible or the scalers are easy to clean. Compliance with these requirements cannot be objectively assessed. They are considered as fulfilled if all tests specified in clause 6 are passed. All tests described in this International Standard are type tests. 4.1.2 Materials All materials used in the construction of dental air-powered scalers should be suitable for their intended use. When tested in accordance with 6.1 0, dental air-powered scalers shall be resistant to cleaning, disinfecting and sterilizing procedures recommended by the manufacturer. Compliance with these requirements cannot be objectively assessed. They are considered as fulfilled if all tests specified in clause 6 are passed.4.1.3 Construction and layout The construction of dental air-powered scalers should provide for their safe and reliable operation. If field- repairable, the scalers should be capable of being easily disassembled and reassembled for maintenance and repair, utilizing either readily available tools or special tools supplied by the manufacturer. Compliance with these requirements cannot be objectively assessed. They are considered as fulfilled if all tests specified in clause 6 are passed. 4.1.4 Dimensions If the manufacturer includes the dimensions of the scaler tip in the operator’s manual, they shall be the dimensions 2 and 3 named in Figure 1 and shall be expressed to an accuracy of ? 0,2 mm, using the nomenclature of Figure 1 . Testing shall be carried out by inspection and measurement in accordance with 6.2. 4.1.5 Handpiece connection The configuration, dimensions and tolerances of hose connections shall be in accordance with ISO 91 68. Testing shall be carried out by inspection and measurement in accordance with 6.1 .