GB 12259-1990
Abolished
YY 1301-2016
Active
Industry standards-Medicine
YY 1301-2016 Therapeutic laser equipment—Er:YAG laser equipment for therapy
YY 1301-2016 Therapeutic laser equipment—Er:YAG laser equipment for therapy
Basic Information
Standard Code:
YY 1301-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical ultrasound, laser, and high-frequency instruments and equipment
ICS Name:
Treatment equipment
Publish Date:
2016-03-23
Implement Date:
2018-01-01
Pages:
13 pages
Scope
This standard specifies the basic parameters, product composition, technical requirements, test methods, and requirements for marking labels and packaging of Er:YAG laser treatment machines.
This standard applies to Er:YAG laser treatment machines (hereinafter referred to as treatment machines) with a wavelength of 2.94 μm. The treatment machine achieves its therapeutic effect by vaporizing, carbonizing, and coagulating human tissue with Er laser pulses.
Development Information
Referenced Standards
GB/T 17736-1999 Testing method of main parameters for laser protective eyewear
ISO 11146-1
ISO 11146-2
ISO/TR 11146-3
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 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
YY/T 0758-2009 General requirements for therapeutic laser fiber
YY/T 0758-2021 General requirements for medical laser fiber
YY/T 1057-2016 General specifications for medical foot switch
GB/T 7247.1-2024 Safety of laser products—Part1:Equipment classification and requirements
YY 1057-2016 General specifications for medical foot switch
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
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GB 10035-1994
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GB 16174.1-1996
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