GB 11533-1989
Replaced
YY 1289-2016
Active
Industry standards-Medicine
YY 1289-2016 Laser treating equipment—Ophthalmic semiconductor laser photocoagulators
YY 1289-2016 Laser treating equipment—Ophthalmic semiconductor laser photocoagulators
Basic Information
Standard Code:
YY 1289-2016
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:
2016-03-23
Implement Date:
2018-01-01
Pages:
13 pages
Scope
This standard specifies the basic parameters, product components, requirements, test methods, inspection rules, and markings, labels, and user manuals of ophthalmic laser coagulators that use semiconductor lasers as light sources (hereinafter referred to as laser coagulators).
This standard applies to equipment used in clinical settings for performing ophthalmic semiconductor laser coagulation surgeries on patients.
Development Information
Superseded by the following standards
Referenced Standards
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 0789-2010 Q-Switched Nd:YAG laser ophthalmic system
YY/T 0844-2011 Laser therapeutic equipment—Pulsed carbon dioxide laser treating instrument
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
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 15313-1994 Terminology for laser
GB/T 15313-2008 Terminology for laser
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 7247.1-2024 Safety of laser products—Part1:Equipment classification and requirements
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
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