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YY 1289-2022: Laser treating equipment - Ophthalmic laser photocoagulators
Status: Valid YY 1289: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 1289-2022 | English | 279 |
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Laser treating equipment - Ophthalmic laser photocoagulators
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YY 1289-2022
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| YY 1289-2016 | English | 279 |
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Laser treating equipment - Ophthalmic semiconductor laser photocoagulators
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YY 1289-2016
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PDF similar to YY 1289-2022
Basic data | Standard ID | YY 1289-2022 (YY1289-2022) | | Description (Translated English) | Laser treating equipment - Ophthalmic laser photocoagulators | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.040.70 | | Word Count Estimation | 13,190 | | Date of Issue | 2022-10-17 | | Date of Implementation | 2025-11-01 | | Older Standard (superseded by this standard) | YY 1289-2016 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the terms and definitions, product composition, requirements, test methods, etc. of the ophthalmic laser photocoagulation instrument. This standard applies to equipment for clinical fundus laser photocoagulation therapy. | YY 1289-2022: Laser treating equipment - Ophthalmic laser photocoagulators---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.70
CCSC41
Pharmaceutical Industry Standard of the People's Republic of China
Replace YY 1289-2016
Laser Therapy Equipment Ophthalmic Laser Photocoagulation
2022-10-17 release
2025-11-01 Implementation
Released by the State Drug Administration
table of contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Product Composition 1
5 requirements 2
6 Test method 5
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents"
drafting.
This document replaces YY 1289-2016 "Ophthalmic Semiconductor Laser Photocoagulation Instrument for Laser Therapy Equipment". Compared with YY 1289-2016,
In addition to structural adjustment and editorial changes, the main technical changes are as follows.
--- Changed the "scope" (see Chapter 1, Chapter 1 of the.2016 edition);
--- Changed the "normative references" (see Chapter 2, Chapter 2 of the.2016 edition);
--- Changed the "terms and definitions" (see Chapter 3, Chapter 3 of the.2016 edition);
--- Changed the "peak wavelength" (see 5.1.1, 5.1.1 of the.2016 edition);
---Changed the "pulse characteristics" (see 5.1.5, 6.1.5, 5.1.5, 6.1.5 of the.2016 edition);
--- Changed the "control of terminal output power (or energy)" (see 5.1.6, 6.1.6, 5.1.6, 6.1.6 of the.2016 edition);
--- Added "foot switch (if applicable)" (see 5.4, 6.4);
--- Deleted the inspection rules, signs, labels, instructions for use, packaging, transportation and storage (see Chapter 7, Chapter 8, Chapter 8 of the.2016 edition
Chapter 9).
Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is sponsored by the National Optical and Photon Standardization Technical Committee Medical Optics and Instruments Sub-Technical Committee (SAC/TC103/SC1)
Focus on.
The previous versions of the documents replaced by this document are as follows.
---YY 1289-2016.
Laser Therapy Equipment Ophthalmic Laser Photocoagulation
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 photocoagulation
Due to the absorption of light radiation, the proteins in biological tissues are thermally denatured.
3.2
Spot diameter spotdiameter
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.
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