YY/T 0795-2022 Active Industry standards-Medicine

YY/T 0795-2022 Particular specification for dental cone-beam computed tomography equipment

Publish Date: 2022-05-18 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0795-2022

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical radiation equipment

ICS Name: X-ray imaging equipment

Publish Date: 2022-05-18

Implement Date: 2023-05-01

Publisher: 国家药品监督管理局

Technical Committee: 全国医用电器标准化技术委员会医用X射线设备及用具分技术委员会(SAC/TC 10/SC 1)

Pages: 28 pages

Scope

本文件规定了口腔颌面锥形束计算机体层摄影设备(以下简称口腔CBCT)的组成、要求和试验方法。
本文件适用于包括利用影像增强器或平板探测器作为图像采集装置的口腔CBCT设备。本文件不适用于口腔CBCT设备的曲面体层摄影和头颅测量摄影部分，相关要求见YY/T 1732。

Development Information

Drafting Units:

辽宁省医疗器械检验检测院、国家药品监督管理局医疗器械技术审评中心、合肥美亚光电技术股份有限公司、卡瓦盛邦(上海)牙科医疗器械有限公司、深圳市菲森科技有限公司、锐珂亚太投资管理(上海)有限公司、北京朗视仪器有限公司

Drafting Persons:

孙智勇、张庆、张建军、曾佳佳、吕广志、张富涛、吴宏新

Word Count: 50 Thousand words Pages: 28 pages

Replace the following standards

YY/T 0795-2010 Particular specification for oral cavity X-ray equipment for digital tomography

Referenced Standards

GB 9706.103-2020 Medical electrical equipment—Part 1-3:General requirements for basic safety and essential performance—Collateral Standard:Radiation protection in diagnostic X-ray equipment GB 9706.228-2020 Medical electrical equipment—Part 2-28:Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis GB 9706.254-2020 Medical electrical equipment—Part 2-54:Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy DICOM 3.0 GB 7247.1-2001 Safety of laser products—Part 1:Equipment classification, requirements and user's guide GB 7247.1-2012 Safety of laser products—Part 1:Equipment classification and requirements GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 10149-1988 Terminology and symbol for medical X-ray equipment YY/T 0291-2007 Environmental requirements and test methods for medical X-ray equipment YY/T 0291-2016 Environmental requirements and test methods for medical X-ray equipment YY/T 1466-2016 Oral cavity X-ray equipment for digital tomography—Evaluation method for determination of bone mineral density YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests GB/T 7247.1-2024 Safety of laser products—Part1:Equipment classification and requirements YY/T 0291-1997 The environmental requirements and testing methods for medical X-ray equipment

Related Standards

GB 4505-1984 Abolished

GB 4505-1984 The general specifications on medical diagnostic X-ray generating unit

Publish Date: 1984-06-22

GB 5579-1985 Abolished

GB 5579-1985 High-voltage cable plug and socket connections for medical X-ray equipment

Publish Date: 1985-10-31

GB 5665-1985 Abolished

GB 5665-1985 General specification for mechanical units of medical diagnostic X-ray equipment

Publish Date: 1985-11-30

GB 10151-1988 Abolished

GB 10151-1988 Medical X-ray equipment—Specification for high voltage cable plug and socket connections

Publish Date: 1988-12-22

GB/T 10149-1988 Active

GB/T 10149-1988 Terminology and symbol for medical X-ray equipment

Publish Date: 1988-12-22

GB 11239-1989 Replaced

GB 11239-1989 The operation microscope

Publish Date: 1989-03-31