YY/T PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE S REPUBLIC OF CHINA. Translated English of Chinese Standard: YY/T

Transcription

1 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE S REPUBLIC OF CHINA Translated English of Chinese Standard: YY/T Sales@ChineseStandard.net YY ICS C 33 YY/T Titanium and titanium alloy dental implant attachments 钛及钛合金材质牙种植体附件 YY/T How to BUY & immediately GET a full-copy of this standard? Search --> Add to Cart --> Checkout (3-steps); 3. No action is required - Full-copy of this standard will be automatically & immediately delivered to your address in 0~60 minutes. 4. Support: Sales@ChineseStandard.net. Wayne, Sales manager Issued on: December 30, 2009 Implemented on: June 01, 2011 Issued by: China Food and Drug Administration Page 1 of 13

2 Table of Contents Foreword... 3 Introduction Scope Normative references Terms and definitions Material Requirements Test method Packaging, marking and instruction manual References Page 2 of 13

3 Foreword All the technical contents of this standard are recommended. Please note that some of the contents of this standard may involve patents. The issuer of this standard shall not be responsible for the identification of these patents. This standard was proposed by China Food and Drug Administration. The standard shall be under the jurisdiction of the National Dental Materials and Equipment Standardization Technical Committee (SAC/TC 99). The responsible drafting organization of this standard: Peking University School of Stomatology Oral Medical Equipment Testing Center. The participating drafting organizations of this standard: Peking University School of Stomatology. The main drafters of this standard: Lin Hong, Zhang Yan, Li Yuan, Zheng Gang, Qiu Lixin. Page 3 of 13

4 Titanium and titanium alloy dental implant attachments 1 Scope This standard specifies the performance requirements and corresponding test methods for the dental implant attachments of titanium and titanium alloys, as well as the packaging. The dental implants in this standard refer to various ancillary components used in conjunction with dental implants to support the upper structure (prosthesis) of the implanted denture, including abutments and central screws. The dental implant attachments in this standard also include the cover screw, healing cap, and healing abutment which are used on the implant before assembling the upper structure. This standard does not cover the devices used for the upper structure which is made in the dental laboratory (e.g. transfer body, retention screw, connection ring, and upper structure, etc.). 2 Normative references The provisions in following documents become the provisions of this Standard through reference in this Standard. For the dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this Standard; however, parties who reach an agreement based on this Standard are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies. GB/T Methods for chemical analysis of sponge titanium, titanium and titanium alloys GB/T Dental vocabulary - Part 1: General and clinical terms (ISO :1989, IDT) GB/T Dental vocabulary - Part 2: Dental material (ISO :1989, IDT) GB/T Wrought titanium and titanium alloy for surgical implants YY/T Liquid penetrant inspection of metallic surgical implants (ISO 9583:1993, NEQ) YY/T Dentistry implants - Dynamic fatigue test for endosseous dental implants (ISO 14801: 2007, IDT) Page 5 of 13

5 Note: The abutment can be connected to the implant via a central screw, OR otherwise connected to the implant through embedding or other methods. Central screw A screw that penetrates the center of the abutment AND fastens the abutment onto the implant. Cover screw, healing screw, closure screw After the implant is implanted in the jaw, the cap structure above the implant is screwed in to avoid tissue growth. During secondary operation, the cover screw is taken out, AND the abutment is installed in place. Healing cap/hygiene screw, hygiene cover screw, hygiene cap Attachments which are temporarily installed onto the abutment end. Healing abutment A transitional abutment. In the soft tissue healing period after surgery, the healing abutment is attached to the implant, which helps the soft tissue to be shaped in accordance with the shape of the healing abutment AND then replaced by the abutment. 4 Material It shall comply with GB/T Wrought titanium and titanium alloy for surgical implants. 5 Requirements 5.1 Appearance Page 7 of 13

6 the tweezers to take all the implant attachments out from the beaker; USE the qualitative filter paper to filter the liquid in the beaker; AND there shall be no visible attachment on the filter paper. 6.7 Fatigue limits MAKE test in accordance with YY/T , AND the test results shall comply with the provisions of clause Chemical composition MAKE test in accordance with GB/T , AND the chemical composition shall comply with the provisions of clause Sterile MAKE test in accordance with the Appendix XI H Sterile test method of the Pharmacopoeia of the People s Republic of China (Volume II), AND the test results shall comply with the provisions of clause Pyrogen MAKE test in accordance with the Appendix XI H Pyrogen test method of the Pharmacopoeia of the People s Republic of China (Volume II), AND the test results shall comply with the provisions of clause Packaging, marking and instruction manual 7.1 Product marking If the size and surface conditions of the dental implant attachment permit, under the preconditions of not affecting the use performance of the dental implant attachment, it shall make clear manufacturer marking, product batch (serial) number, and specification marking on an appropriate region at each dental implant attachment surface. However, if the size and surface conditions do not permit, it shall use the label or other methods to provide the information required, in order to ensure the traceability. 7.2 Labeling and packaging mark The labeling and packaging mark of dental implant attachment shall include at least the following: a) Product name, model, specification; b) Manufacturer's name, address, and contact information; Page 10 of 13