GB 11533-1989
Replaced
YY/T 0634-2022
Active
Industry standards-Medicine
YY/T 0634-2022 Ophthalmic instruments—Fundus cameras
YY/T 0634-2022 Ophthalmic instruments—Fundus cameras
Basic Information
Standard Code:
YY/T 0634-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical optical instruments and equipment, and endoscopes
ICS Name:
Ophthalmic equipment
Publish Date:
2022-07-01
Implement Date:
2023-07-01
Publisher:
国家药品监督管理局
Technical Committee:
全国光学和光子学标准化技术委员会医用光学和仪器分技术委员会(SAC/TC 103/SC 1)
Pages:
20 pages
Scope
本文件规定了眼底照相机的要求和试验方法。眼底照相机用于观察、拍摄或记录人眼眼底电子图像,以提供用于诊断的图像信息。
本文件适用于采用照相机成像原理的仪器。
本文件不适用于以下仪器:
——在检查过程中接触眼睛的仪器;
——使用扫描成像技术、自适应光学成像技术、光学相干断层成像技术(OCT)、多单色光谱成像技术的仪器。
Development Information
Drafting Units:
浙江省医疗器械检验研究院、国家药品监督管理局医疗器械技术审评中心
Drafting Persons:
王敬涛、陈敏、贾晓航、彭建华、何涛、胡一平
Replace the following standards
Referenced Standards
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
ISO 15004-1
ISO 15004-2:2007
GB/T 5702-2003 Methods of measuring the color of light sources
GB/T 5702-2019 Method of measuring the color rendering properties of light sources
GB/T 7922-2003 Method of measuring the color of light sources
GB/T 7922-2008 Method of measuring the color of light sources
GB/T 7922-2023 Method of measuring color of light sources
Adopt standards
ISO 10940:2009
Related Standards
GB/T 14148-1993
Replaced
GB/T 14148-1993 Glass blank of ophthalmic lenses
GB/T 14214-1993
Replaced
GB/T 14214-1993 Spectacle frames
GB 10810-1996
Replaced
GB 10810-1996 Spectacles lenses
GB 17342-1998
Replaced
GB 17342-1998 Ophthalmic instrument—Trial case lenses
GB 13511-1999
Replaced