GB 11533-1989
Replaced
YY 1289-2022
Active
Industry standards-Medicine
YY 1289-2022 Laser treating equipment—Ophthalmic laser photocoagulators
YY 1289-2022 Laser treating equipment—Ophthalmic laser photocoagulators
Basic Information
Standard Code:
YY 1289-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical ultrasound, laser, and high-frequency instruments and equipment
ICS Name:
Ophthalmic equipment
Publish Date:
2022-10-17
Implement Date:
2025-11-01
Publisher:
国家药品监督管理局
Technical Committee:
全国光学和光子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:
16 pages
Scope
本文件规定了眼科激光光凝仪(以下简称光凝仪)的术语和定义、产品组成、要求、试验方法等内容。
本文件适用于临床上进行眼底激光光凝治疗的设备。
Development Information
Replace the following standards
Referenced Standards
YY 0789-2010 Q-Switched Nd:YAG laser ophthalmic system
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 9706.20-2000 Medical electrical equipment—Part 2:Particular requirements for the safety of diagnostic and therapeutic laser equipment
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
GB/T 26599.1-2011 Lasers and laser-related equipment—Test methods for laser beam widths,divergence angles and beam propagation ratios—Part 1:Stigmatic and simple astigmatic beam
YY/T 1057-2016 General specifications for medical foot switch
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 1057-2016 General specifications for medical foot switch
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