GB 12259-1990
Abolished
YY 0599-2015
Active
Industry standards-Medicine
YY 0599-2015 Therapeutic laser equipment—Excimer laser cornea ametropia cure system
YY 0599-2015 Therapeutic laser equipment—Excimer laser cornea ametropia cure system
Basic Information
Standard Code:
YY 0599-2015
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical ultrasound, laser, and high-frequency instruments and equipment
ICS Name:
Treatment equipment
Publish Date:
2015-03-02
Implement Date:
2017-01-01
Pages:
13 pages
Scope
This standard specifies the terms and definitions, structure, and basic parameters, requirements, test methods, inspection rules, marking, packaging, transportation, and storage of excimer laser corneal refractive surgery machines.
This standard applies to excimer laser corneal refractive surgery machines (hereinafter referred to as "surgery machines"). The surgery machines use 193 nm excimer lasers to remove corneal tissue to change the shape of the cornea and thereby improve vision. They are mainly used in refractive corneal surgery (PRK), in situ corneal ablation (LASIK), and therapeutic corneal ablation (PTK).
Development Information
Replace the following standards
Superseded by the following standards
Referenced Standards
GB 11239.1-2005 Operation microscopes—Part 1:Requirements and test methods
YY 91057-1999
ISO 10936-2
ISO 15004-2
ANSI Z80.11-2007
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 17736-1999 Testing method of main parameters for laser protective eyewear
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 12261-1990
Abolished
GB 12261-1990 Artificial heart-lung machine—Bubble oxygenator
GB 12262-1990
Abolished
GB 12262-1990 Artificial heart-lung machine—Heat exchanger
GB 2024-1994
Replaced
GB 2024-1994 Acupuncture needles
GB 10035-1994
Replaced
GB 10035-1994 The air-bag type sequential external counter-pulsation device
GB 16174.1-1996
Replaced