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

Publish Date: 2016-03-23 Implement Date: 2018-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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

Word Count: 21 Thousand words Pages: 13 pages

Superseded by the following standards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

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