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YY 0599-2024: Laser therapeutic equipment - Excimer laser cornea ametropia equipment
Status: Valid YY 0599: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0599-2024 | English | 369 |
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Laser therapeutic equipment - Excimer laser cornea ametropia equipment
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YY 0599-2024
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| YY 0599-2015 | English | 155 |
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Therapeutic laser equipment - Excimer laser cornea ametropia cure system
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YY 0599-2015
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| YY 0599-2007 | English | 399 |
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Excimer laser cornea ametropia cure system
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YY 0599-2007
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PDF similar to YY 0599-2024
Standard similar to YY 0599-2024 YY/T 0593 YY 0592 YY 0599 Basic data | Standard ID | YY 0599-2024 (YY0599-2024) | | Description (Translated English) | Laser therapeutic equipment - Excimer laser cornea ametropia equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 18,164 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2027-07-20 | | Older Standard (superseded by this standard) | YY 0599-2015 | | Issuing agency(ies) | State Drug Administration | YY 0599-2024: Laser therapeutic equipment - Excimer laser cornea ametropia equipment---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 11.040.60
CCSC41
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0599-2015
Laser therapy equipment
Excimer laser corneal refractive therapy device
Released on 2024-07-08
2027-07-20 Implementation
The State Drug Administration issued
Table of Contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirement 2
5 Test methods 4
Appendix A (Normative) Spectral weighting function for ultraviolet radiation hazard analysis 8
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 0599-2015 "Laser Therapy Equipment Excimer Laser Corneal Refractive Therapy Machine" and is consistent with YY 0599-2015
In addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- Changed "Scope" (see Chapter 1, Chapter 1 of the.2015 edition);
--- Deleted the term and definition of "small spot scanning" (see 3.1 of the.2015 edition);
--- Deleted the term and definition of "slit spot scanning" (see 3.2 of the.2015 edition);
--- Deleted the term and definition of "hybrid variable spot scanning" (see 3.3 of the.2015 edition);
--- Deleted the term and definition of "energy density" (see 3.6 of the.2015 edition);
--- Deleted "Product composition and basic parameters" (see Chapter 4 of the.2015 edition);
--- Deleted the requirements for "normal working conditions" (see 5.1 of the.2015 edition);
--- Changed the requirements for "laser wavelength" (see 4.1.1, 5.2.1 of the.2015 edition);
--- Changed the requirements for "laser mode" (see 4.1.2, 5.2.2 of the.2015 edition);
--- Changed the requirements for "laser terminal output power (energy)" (see 4.1.3, 5.2.3 of the.2015 edition);
--- Deleted the requirement of “laser treatment surface energy density” (see 5.2.4 of the.2015 edition);
--- Changed the requirements for "laser pulse width" (see 4.1.4, 5.2.5 of the.2015 edition);
--- Changed the requirements for "laser repetition frequency" (see 4.1.5, 5.2.6 of the.2015 edition);
--- Changed the requirements for "spot size of laser treatment surface" (see 4.1.6, 5.2.8 of the.2015 edition);
--- Changed the requirements for "laser terminal output divergence angle" (see 4.1.7, 5.2.7 of the.2015 edition);
--- Changed the requirements for "Laser terminal output power (energy) instability (St)" (see 4.1.8, 5.2.9 of the.2015 edition);
--- Changed the requirements for "Reproducibility (Rp) of laser terminal output power (energy)" (see 4.1.9, 5.2.10 of the.2015 edition);
--- Changed the requirements for "alignment system" (see 4.2, 5.3 of the.2015 edition);
--- Changed the requirements for "scope of corrected vision zone" (see 4.3, 5.4 of the.2015 edition);
--- Changed the requirements for "eye tracking system" (see 4.6, 5.7 of the.2015 edition);
--- Added the requirements for "aiming system" (see 4.7);
--- Changed the requirements for "patient support system" (see 4.9, 5.9 of the.2015 edition);
--- Changed the requirements for "auxiliary light source" (see 4.10, 5.10 of the.2015 edition);
--- Changed the requirements for "foot switch" (see 4.11, 5.11 of the.2015 edition);
--- Added "electromagnetic compatibility" requirements and test methods (see 4.14, 5.14);
--- Changed the method of "Photobiological Hazard" (see 5.12, 6.14.2 of the.2015 edition);
--- Deleted the requirements and test methods for "laser protective glasses" (see 5.12 and 6.12 of the.2015 edition);
--- Deleted the requirements and test methods for "appearance" (see 5.13 and 6.13 of the.2015 edition);
--- Deleted the requirements and methods of "environmental adaptability" (see 5.15 and 6.15 of the.2015 edition);
--- Deleted the chapter "Inspection Rules" (see Chapter 7 of the.2015 edition);
--- Deleted the chapter "Marking, Labeling, Instructions for Use" (see Chapter 8 of the.2015 edition);
--- Deleted the chapter “Packaging, Transport and Storage” (see Chapter 9 of the.2015 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed and coordinated by the State Food and Drug Administration.
The previous versions of this document and the documents it replaces are as follows.
---First issued in.2007 as YY 0599-2007, first revised in.2015;
---This is the second revision.
Laser therapy equipment
Excimer laser corneal refractive therapy device
1 Scope
This document specifies the requirements for excimer laser keratoplasty devices and describes the corresponding test methods.
This document applies to the excimer laser corneal refractive therapy device (hereinafter referred to as the therapy device).
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies 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 9706.222 Medical electrical equipment Part 2-22.Basic safety and basic requirements of laser equipment for surgery, plastic surgery, treatment and diagnosis
Special requirements for this performance
GB 11239.1-2005 Surgical microscopes Part 1.Requirements and test methods
YY/T 1057 General technical requirements for medical foot switches
YY 1296 Optics and Photonics Surgical Microscopes Optical Hazards of Ophthalmic Surgical Microscopes
YY 9706.102 Medical electrical equipment Part 1-2.General requirements for basic safety and essential performance Collateral standard. Electromagnetic compatibility
Requirements and tests
ISO 15004-2 Ophthalmic instruments Basic requirements and test methods Part 2.Protection against light hazards (Ophthalmicinstru-
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Correction zone optical zone
The area of the cornea that receives all intended refractive treatment.
Note. The treatment area is the sum of the corrected vision area and the transition zone, which is the entire corneal area involved in laser treatment. The transition zone is outside the corrected vision area, but
And within the treatment area.
3.2
alignment
Position the therapeutic laser beam to the desired location for treatment.
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