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GB/T 46009-2025: Dentistry - Minimal dental implant data set for clinical use
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GB/T 46009-2025: Dentistry - Minimal dental implant data set for clinical use

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ICS 11.060.15 CCSC33 National Standard of the People's Republic of China Minimum dataset of dental implants for clinical application in dentistry (ISO 16498.2013, IDT) Released on August 1, 2025 Implementation on August 1, 2026 State Administration for Market Regulation The National Standardization Administration issued

Table of Contents

Preface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Basic Information 2 References 5 Preface This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document is equivalent to ISO 16498.2013 "Minimum data set for dental implants for clinical application in dentistry". Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Dental Materials and Instruments (SAC/TC99). This document was drafted by. Peking University School of Stomatology, Tianjin Medical University Stomatological Hospital, Peking University School of Stomatology Oral Medical Devices Mechanical Inspection Center. The main drafters of this document are. Zhou Yongsheng, Han Jianmin, Liu Jianzhang, Zhang Xuehui, Xu Yongxiang, Yuan Shenpo, He Ying, Liu Yunsong, Ye Hongqiang, and Li Ying.

introduction

Oral implant is a treatment method based on intraosseous devices and has been widely used. The service life of implants can reach several decades, but Maintenance may also be required during this period. The success of implant surgery is highly dependent on the availability and accuracy of prefabricated precision components. Parts need to be specially customized and the design may be frequently changed during production. Therefore, implant treatment requires sufficient and accurate information to support This document describes the minimum data set that meets this requirement and can also be used to Scientific research, judicial appraisal and determination of medical malpractice disputes. The dataset developed in this document aims to facilitate the patient care of implant patients by recording the details of implants and related connection components and auxiliary devices. The information related to the treatment process is collected by the relevant clinicians and its content is not included in this dataset. Minimum dataset of dental implants for clinical application in dentistry

1 Scope

This document specifies the minimum data set that needs to be recorded for patients undergoing dental implant treatment, including the implants placed in the patient's jaw, the connections The location and type of components and auxiliary devices (including implant material). This document is for the record of patient information for dental implant treatment. This information will be recorded in the patient file by the responsible clinician and The clinician who provides the treatment provides it to the patient.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. ISO 1942 Dentistry - Vocabulary Note. GB/T 9937-2020 Dental Terminology (ISO 1942.2009, MOD) oftheoralcavity) Note. GB/T 9938-2013 Dentistry — Designation of tooth positions and oral areas (ISO 3950.2009, IDT) mationinterchange) Note. GB/T 7408.1 (all parts) Date and time information interchange representation [ISO 8601 (all parts)]

3 Terms and Definitions

For the purposes of this document, the terms and definitions defined in ISO 1942 and the following apply. 3.1 dataset A specification of linked data elements that form unique relationships. 3.2 dental implant A special device used to pass through, be placed inside or on the craniomaxillofacial bone to support the restoration and resist its displacement. [Source. ISO 1942.2020, 3.71, modified]. 3.3 connecting components A single part or component that connects to the implant and supports the implant's function. [Source. ISO 1942.2020, 3.72, modified]. 3.4 grafting materials Materials of allogeneic, heterogeneous, xenogeneic or autologous origin intended for implantation or transplantation to replace or repair defective or damaged human tissue. ...