This document specifies the product classification and requirements for Q-switched ophthalmic laser equipment, and describes the corresponding test methods.
This document is applicable to Q-switched ophthalmic laser equipment (hereinafter referred to as the “therapeutic equipment”).
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 7247.1-2012 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: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
YY 9706.102 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
3 Terms and definitions
There are no terms and definitions that need to be defined in this document.
4 Product classification
According to the laser terminal pulse output mode, the output mode of the therapeutic equipment may be divided into single pulse output and pulse train output. According to the number of sub-pulses in a single output, the pulse train output mode may be divided into dual pulse, triple pulse, quadruple pulse, etc. The waveform diagram for the laser pulse output mode (taking the triple pulse mode for the pulse train output as an example) is shown in Figure 1.
Key:
τ——Sub-pulse width;
t——Pulse train width;
T——Repetitive pulse train period.
Foreword I 1 Scope 2 Normative references 3 Terms and definitions 4 Product classification 5 Requirements 6 Test methods
Laser therapeutic equipment - Q-switched ophthalmic laser equipment
1 Scope
This document specifies the product classification and requirements for Q-switched ophthalmic laser equipment, and describes the corresponding test methods.
This document is applicable to Q-switched ophthalmic laser equipment (hereinafter referred to as the “therapeutic equipment”).
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 7247.1-2012 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: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
YY/T 0065 Ophthalmic instruments - Slit-lamp 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
3 Terms and definitions
There are no terms and definitions that need to be defined in this document.
4 Product classification
According to the laser terminal pulse output mode, the output mode of the therapeutic equipment may be divided into single pulse output and pulse train output. According to the number of sub-pulses in a single output, the pulse train output mode may be divided into dual pulse, triple pulse, quadruple pulse, etc. The waveform diagram for the laser pulse output mode (taking the triple pulse mode for the pulse train output as an example) is shown in Figure 1.
Key:
τ——Sub-pulse width;
t——Pulse train width;
T——Repetitive pulse train period.
Contents of YY 0789-2024
Foreword I
1 Scope
2 Normative references
3 Terms and definitions
4 Product classification
5 Requirements
6 Test methods
