YY 1289-2022Laser treatment equipment - Ophthalmic laser photocoagulator (English PDF)
激光治疗设备 眼科激光光凝仪
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
October 17, 2022
Implementation date
November 1, 2025
Scope
YY 1289-2022 is the English-translated version of 激光治疗设备 眼科激光光凝仪.
YY 1289-2022 is the Chinese standard "Laser treatment equipment - Ophthalmic laser photocoagulator". Its scope clause reads: This document specifies the terms and definitions, product composition, requirements, test methods, etc. of ophthalmic laser photocoagulation apparatus (hereinafter referred to as photocoagulation apparatus).
This document is applicable to equipment for clinical fundus laser photocoagulation therapy. Its clauses include terms and definitions; product composition.
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Document preview — YY 1289-2022
National Standard of the People's Republic of China
- ICS
- 11.040.70
- Classification
- C41
- Replacing
- YY 1289-2016
Issued by: National Medical Products Administration
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Product Composition
- 5 requirements
- 6 Test method
1 Scope
This document specifies the terms and definitions, product composition, requirements, test methods, etc. of ophthalmic laser photocoagulation apparatus (hereinafter referred to as photocoagulation apparatus).
This document is applicable to equipment for clinical fundus laser photocoagulation therapy.
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.
GB 7247.1 Safety of Laser Products Part 1.Equipment Classification and Requirements
GB 9706.1 Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Essential Performance
GB 9706.20 Medical electrical equipment Part 2.Special requirements for the safety of diagnostic and therapeutic laser equipment
GB/T 14710 Environmental requirements and test methods for medical electrical equipment
GB/T 26599.1 Test methods for laser beam width, divergence angle and beam transmission ratio of lasers and laser related equipment Part 1
Divide into. astigmatism-free and simple astigmatism beams
YY 0789-2010 Q switch Nd.YAG laser eye treatment machine
YY 1057 General Technical Specifications for Medical Foot Switches
YY 9706.102 Medical Electrical Equipment Part 1-2.General Requirements for Basic Safety and Essential Performance Collateral Standard. Electromagnetic Compatibility
Content requirements and tests
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Photocoagulation
Due to the absorption of light radiation, the proteins in biological tissues are thermally denatured.
3.2 Spot diameter
When measured in air, the diameter of the smallest circular area containing 86.5% of the radiant power [that is, the light intensity within the irradiation range of the spot along the diameter
The diameter value when it is reduced to 1/e2 (13.5%) of the center].
4 Product Composition
A photocoagulator should at least contain the following components.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 9 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 7247.1Safety of laser products - Part 1: Equipment classification and requirements
- GB 9706.1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 14710The environmental requirement and test methods for medical electrical equipment
- GB/T 26599.1Lasers and laser-related equipment -- Test methods for laser beam widths, divergence angles and beam propagation ratios -- Part 1: Stigmatic and simple astigmatic beam
- YY 0789-2010Laser therapeutic equipment - Q-switched ophthalmic laser equipment
- YY 1057General specifications for medical foot switches
GB 9706.20
Editions of YY 1289
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 1289-2022 | Laser treatment equipment - Ophthalmic laser photocoagulator | current edition | Current |
| YY 1289-2016 | Laser treatment equipment - Ophthalmic laser photocoagulator | previous edition | In force until 2025-11-01 |
This page sells the current edition, YY 1289-2022. Earlier editions are listed for reference only.
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Related Standards
GB 7247.1-2012 — Safety of laser products - Part 1: Equipment classification and requirements
GB 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.103-2020 — Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
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YY 1289-2022
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