Report 2016 of Subcommittee 4 Dental instruments

Transcription

1 Document ISO/TC 106 N INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ISO/TC 106/SC 4 Dental instruments Secretariat: DIN; Dr. H.-P. Keller Address: Alexander-Wellendorff-Str. 2; Pforzheim/Germany Phone: Fax: hans-peter.keller@din.de http: // Report 2016 of Subcommittee 4 Dental instruments 1 Members of SC 4 Participating countries (P-members): 20 Australia, Austria, Belgium, Canada, China, France, Germany, Iran (Islamic Republic of), Italy, Japan, Korea (Republic of), Netherlands, Norway, Russian Federation, Spain, Sweden, Switzerland, Thailand, United Kingdom, United States. 2 Chairman Dr. H. B. Engels Observer countries (O-members): 11 Czech Republic, Finland, Hong Kong (ITCHKSAR), India, Ireland, Mongolia, Poland, Romania, Saudi Arabia, Serbia, Slovakia. Other ISO and IEC committees in liaison: ISO/TC 76, ISO/TC 145/SC 3, ISO/TC 198. International organizations in liaison: FDI, WHO 3 Secretary Dr. H.-P. Keller, DIN Page 1 of 7 ISO/TC 106/SC 4 Report 2016

2 4 Working Groups WG 1 Dimension of rotary instruments Convenor: G. Offenhammer, Germany WG 5 Numbering system Convenor: A. Pieper, Germany WG 7 Dental handpieces Convenor: J. Nille, Germany WG 8 Dental hand instruments Convenor: Dr. S. Mills, USA WG 9 Endodontic instruments Convenor: Dr. N. Luebke, USA WG 10 Dental injection systems Convenor: Dr. J. Meechan, GB WG 13 Implant instruments Convenor: Dr. H. B. Engels, Germany WG 14 Materials for dental instruments Convenor: Dr. Kwon, Korea 5 Scope Standardization of dental instruments used in the dental office and in the dental laboratory for dental purposes. This includes but is not limited to the following: rotary instruments handpieces and motors scaler handpieces and tips hand held manual instruments endodontic instruments implant instruments syringes, cartridges and needles 6 Brief report on the SC 4 Plenary meeting Tromsoe 2016 The 32 th plenary meeting of ISO/TC 106/SC 4 took place in Tromsoe, Thursday, The meeting was chaired by Dr. H. B. Engels. The meeting was attended by 42 delegates from 11 countries. The attendance of Patricia Bartels from ISO/CS was appreciated. The Chairman thanked the Norwegian host for the excellent meeting organisation. Progress report of Working Groups A total of six working groups of SC 4 met in Tromsoe. The following reports were presented to the SC 4 plenary. WG 1 Dimensions of rotary instruments The convenor, Mr. Offenhammer, presented the report of WG 1. ISO/DIS Shanks for rotary and oscillating instruments: The result of voting on the second DIS ended in 16 YES and 2 NO votes with comments. All received comments were discussed during the meeting. The main points in the discussion were: A figure for "cylindricity" was discussed and a reference to ISO 1101 was made Page 2 of 7 ISO/TC 106/SC 4 Report 2016

3 The subclause for "Pass/fail evaluation" was moved to a general clause "Sampling and pass/fail evaluation". The chapter "Quality control" was moved to an informative annex. SC4 decided to circulate the revised document as FDIS ISO/DIS Laboratory cutters Part 3: Tungsten carbide cutters for milling machines The result of voting ended in 100% acceptance with comments. The main points in the discussion were: The title was changed ("tungsten" was deleted) : Laboratory cutters Carbide cutters for milling machines A note to the tables was added, explaining that the limitations of ISO 1797 do not apply because these laboratory cutters are used in milling machines. The angle limitations are now given in degrees (and no longer in minutes). SC4 decided to circulate the revised document FDIS WG 1 requests a half-day-meeting in WG 7 Handpieces The convenor, Mr. Nille, presented the report of WG 7. Discussion of ISO/DIS Dentistry - Handpieces and motors The comments on ISO/DIS "Handpieces and motors was discussed. The following main decisions were made: To modify the temperature requirements and test procedures. To modify the clause about the Output power of high-speed air turbine handpieces. SC 4 decided to distribute the revised document after as an ISO/FDIS Dentistry Handpieces and motors. Discussion of Committee Draft ISO/CD Dentistry Powder jet handpieces The Project leader Timo Kleinwächter presented "Air driven powder jet handpieces. All the main points were discussed. The following main decisions were made: To improve the definition of airdriven powderjet handpieces. To modify the powder requirements. To limit this standard to air driven powder jet handpieces only and to not include their respective designated dental units. WG 7 decided to distribute the revised document with a deadline on SC 4 noted the retirement of Mr. Nille and thanked him the excellent work performed as convenor of WG 7. Appointment year: 1989; End year: SC 4 appointed as new convenor of Working Group 7 "Dental handpieces" Mr. T. Kleinwächter. Page 3 of 7 ISO/TC 106/SC 4 Report 2016

4 WG 7 requests a full-day-meeting in WG 8 Hand instruments The convenor, Dr. S. Mills, presented the report of WG 8. Comments on ISO DIS 9873 Dentistry Reusable Mouth Mirrors were reviewed and resolved. The work item will advance as a FDIS and will be circulated for review by in advance of the next meeting of ISO TC 106 in Hong Kong in Comments on ISO/CD Dentistry Oral surgical scalpel handle were reviewed. The WG agreed that they would be described as straight, angled, and reverse angled. The WG agreed to call the term of measurement for the position of the connection of the handle relative to the fitting unit the offset. Dr. Jae Sung Kwon (KR) was asked develop a proposal for how this measurement will be expressed. The WG agreed to advance the work item as a DIS for further consideration at the next ISO TC 106 Meeting in The DIS will be circulated for review by members of the WG by Comments on ISO/CD 7492 Dentistry Dental explorers were reviewed and resolved. The WG agreed to combine figures showing basic forms to simplify the document and to remove the column describing numerical designators. Each country was asked to review the dimensions as listed in Table 2 Dimensions of dental explorers and provide feedback to those dimensions. This data to be provided by January 31, 2017 The work item will then be advanced as a DIS for consideration at the next ISO TC 106 meeting and circulated for comments. The WG reviewed and resolved comments ISO/DIS Dentistry Filling instruments with contra-set. The title for this work item has been changed to Filling instruments with contra-angle to better describe this class of instruments. This WG agreed to advance this work item as a FDIS. The revised draft will be circulated for review by WG 8 requests a full-day-meeting in WG 9 Endodontic instruments The convenor, Dr. N. Luebke, presented the report of WG 9. Revision of ISO/CD Dentistry Endodontic instruments Part 1: General requirements and test methods was discussed and corrections made. A cyclic fatigue technique was presented by Mr. Aeby, Switzerland. Revision of ISO/CD Dentistry Endodontic instruments Part 6: Number coding system will be proposed as a CD and ask for comments. NWIP for ultrasonic inserts was accepted and editorial and technical comments were instituted. NWIP was proposed by Korea for the cannula to dispense thermoplastic obturation material and the WG assigned the work item to Some comments were proposed and the Korean delegation graciously agreed to write and submit for comments. Page 4 of 7 ISO/TC 106/SC 4 Report 2016

5 Korea proposed an NWIP for apex locators. WG9 requests clarification but would consider the project if only the efficacy and accuracy is to be considered. SC 4 decided to delete the project ISO/CD WG 9 requested a full day for the 2017 meeting. WG 10 Dental injection systems The acting convenor, Mr. T. Prodger, presented the report of WG 10. WG 10 discussed comments resulting from the voting stage for ISO/CD Dentistry Reusable cartridges for intraligamentary syringes. The significant changes were: The labelling on the mains diagram will be augmented. Clauses relating to requirement for the plunger dimension, rod displacement and method for assessing displacement were deleted and replaced by a requirement for compliance with ISO9997 as these properties were already included therein. A clause for the requirements for protective sleeves was added. The clauses for reprocessing were rewritten to bring them into line with other instruments standards and the requirement for 100 cycles was retained. The procedure for establishing the accuracy of the volume dispensed was rewritten to improve accuracy and clarity. SC4 decided to advance the modified document to the DIS stage. AOB It was agreed that ISO 9997:2000 Dental cartridge syringes should be revised to update the requirements for resistance to reprocessing in line with other dental instrument standards and SC4 will be asked to prepare a resolution for this revision. It was agreed that the WG should try to complete the ISO 9997 revision and the ISO/DIS before the next TC106 so unless any unexpected issues arise no meeting is planned for SC 4/WG 13 Implant instruments The convenor, Dr. H. B. Engels, presented the report of WG 13. Dr. Kwon presented the voting and comments on ISO/DIS Sinus membrane elevator. The document was approved by 14 YES and 0 NO votes. The proposal to specify the length, only for instruments over 178 mm, on the package was disapproved. The revised document shall be distributed as FDIS until Page 5 of 7 ISO/TC 106/SC 4 Report 2016

6 Dr. J.-S. Kwon presented the voting and comments on ISO/CD "Trephine burs". The definition for trephine bur was improved. It was decided that the end of the working part with the cutting teeth shall be conical in order to avoid overheating the bone. The tolerances for the dimensions were changed from percent values (e.g. ±0,5 %) to mm values (e.g ± 0,01 mm). Hardness testing was restricted to Vickers hardness only (not Rockwell). It was changed from HV5 to HV2. The revised document shall be distributed as DIS until WG 13 requests a half-day-meeting in SC 4/WG 14 Materials for dental instruments The convenor of the Ad-Hoc Group "Materials for dental instruments", Dr. J.-S. Kwon, presented the report of the Ad-Hoc Group. The Ad-Hoc WG reviewed the voting results from ISO/NWIP Dentistry Materials for dental instruments and the backgrounds of the NWIP proposals in relation to exclusion of dental instruments from pre-existing ISO 7153 Surgical instruments Materials Part 1: Metals in its FDIS version was explained by convenor. The need of urgency to replace ISO 7153 by new standard was agreed upon all experts and the scope was therefore confined to consider dental instruments made from stainless steel metals for this standard for the quicker process. The title of the standard was therefore changed to Dentistry Materials for dental instruments Part 1: Stainless steel and it was agreed upon experts to work on other metallic or non-metallic materials for dental instruments in later stage. It was also suggested that performance attribute and biocompatibility considerations when selecting materials for dental instruments shall be included in the standard, which may be adapted from ISO 13504, Dentistry General requirements for instruments and related accessories used in dental implant placement and treatment. Convenor explained the table which was also adapted from ISO 13504, and being modified in consideration of ISO/FDIS 7153 Surgical instruments Materials Part 1: Metals. Request to provide information on what stainless steels were used for current marketed dental instruments were given to all of participating experts. Draft of the standard will be then submitted, once information is gathered, with target date of SC 4 decided to establish a new working group 14 "Materials for dental instruments" and appointed Dr. Kwon (Korea) as convenor. SC 4 has no resolution for the TC 106 Plenary meeting. Future meeting Page 6 of 7 ISO/TC 106/SC 4 Report 2016

7 SC 4 intends to hold its next meeting together with the annual TC 106 meeting in Hongkong Respectfully submitted Dr. Helmut B. Engels Chairman of ISO/TC 106/SC 4 Page 7 of 7 ISO/TC 106/SC 4 Report 2016