Translated English of Chinese Standard: YY0065-2016 www.chinesestandard.net Buy True-PDF Auto-delivery. Sales@ChineseStandard.net PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE S REPUBLIC OF CHINA YY ICS 11.040.70 C 40 YY0065-2016 Replacing YY0065-2007 Ophthalmic instruments - Slit-lamp microscopes 眼科仪器裂隙灯显微镜 (ISO 10939: 2007, MOD) Issued on: January 26, 2016 Implemented on: January 1, 2018 Issued by: China Food and Drug Administration www.chinesestandard.net Buy True-PDF Auto-delivery. Page 1 of 15
Table of Contents Foreword... 3 1 Scope... 5 2 Normative references... 5 3 Terms and definitions... 5 4 Requirements... 6 5 Test methods... 9 6 Accompanying files... 15 7 Marks... 15 www.chinesestandard.net Buy True-PDF Auto-delivery. Page 2 of 15
Foreword This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 0065-2007 "Ophthalmic instruments - slit-lamp microscopes"; compared with YY 0065-2007, the main technical changes of this standard are as follows: -- Add the requirements for focus difference between left and right observation systems (see Table 1, serial number 7); -- Add the requirements for optical radiation hazards (see 4.4); -- Delete the requirements for minimum spot size (2007 version 4.1.3); -- Delete the requirements for slit spot illuminance (2007 version 4.1.6); -- Delete the requirements for diameter of field of view (2007 version 4.1.5); -- Delete the requirements for mechanical movement (2007 version 4.2); -- Delete the requirements for environmental test (2007 version 4.5). This standard uses the redrafted law to amend and adopt ISO 10939:2007 "Ophthalmic Instruments - slit-lamp microscopes". Compared with ISO 10939:2007, there are technical differences in this standard. The terms involved in these differences have been indicated by a vertical single line ( ) in the marginal position on its outer side. The technical differences between this standard and ISO 10939:2007 and its causes are as follows: -- With regard to normative references, this standard has made adjustments with technical differences to adapt to China's technical conditions. The adjustments are centrally reflected in Chapter 2 normative references and the specific adjustments are as follows: Use GB 9706.1 which is adopted to be equivalent to international standard to replace IEC 60601-1; -- Add "this standard applies to universal slit-lamp microscopes" in the scope of Chapter 1. -- Add Chapter 5 test methods. As the recommended test methods, it makes the requirements of this standard operable. There is no test method in ISO 10939:2007. www.chinesestandard.net Buy True-PDF Auto-delivery. Page 3 of 15
Ophthalmic instruments - Slit-lamp microscopes 1 Scope This standard, together with ISO 15004-1 and ISO 15004-2:2007, specifies the requirements and test methods for slit-lamp microscopes. This standard applies to universal slit-lamp microscopes. This standard does not apply to slit-lamp microscope accessories, such as camera equipment and lasers. If there are differences, this standard takes precedence over ISO 15004-1 and ISO 15004-2:2007. 2 Normative references The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document. GB 9706.1 Medical electrical equipment - Part 1: General requirements for safety (GB 9706.1-2007, IEC 60601-1:1988, IDT) ISO 15004-1 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments ISO 15004-2:2007 Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection 3 Terms and definitions The following terms and definitions apply to this document. 3.1 Slit-lamp microscope It is an instrument that consists of microscope and rotating illumination system which is capable of producing slit image. www.chinesestandard.net Buy True-PDF Auto-delivery. Page 5 of 15
e) At the highest visual angular magnification, the resolution of field-of-view center shall be at least 1800Nlp/mm (N is numerical aperture). 4.3.2 High eye point eyepiece If the manufacturer claims to be high eye point eyepiece, the distance between the exit pupil of observation system and the closest part of eyepiece shall be no less than 17mm. 4.4 Optical radiation hazard of slit-lamp microscopes Slit-lamp microscopes shall meet the requirements of ISO 15004-2:2007 for light hazard protection. Slit-lamp microscopes shall be classified as Class-1 instruments or Class-2 instruments according to ISO 15004-2:2007 Chapter 4. ISO 15004-2:2007 applied to slit-lamp microscopes is as follows: a) For Class-1 slit-lamp microscopes: 1) 5.1, 5.2 and 5.4 of ISO 15004-2:2007 apply. 2) The test methods of 6.1, 6.2, 6.4 and 6.5 of ISO 15004-2:2007 apply. 3) If it is determined to be Class-1 instruments, there are no more requirements; if it is determined not to belong to Class-1 instruments, more requirements specified in b) shall apply. b) For Class-2 slit-lamp microscopes: 1) 5.1, 5.3 and 5.5 of ISO 15004-2:2007 apply. 2) The test methods of 6.1, 6.2, 6.3, 6.4, 6.5 and 6.6 of ISO 15004-2:2007 apply. 3) ISO 15004-2:2007 Chapter 7 applies. If the intended use of slit-lamp microscopes includes the use of an accessory 90D lens, measure the related exposure of cornea and lens. The 90D lens (such as Volk lens) shall be placed at 7mm position behind the focal plane of slit-lamp with the largest illuminated area. Exposure measurement is taken at the minimum dimension point of the illuminated area 7mm behind the 90D lens. 5 Test methods 5.1 Overview www.chinesestandard.net Buy True-PDF Auto-delivery. Page 9 of 15
microscope) to focus reticle, and the image is clear. Measure the maximum amount of movement between the two after changing the magnification. The result shall meet the requirements of No. 4 in Table 1. 5.6 Errors of the focal plane of lighting system with respect to mechanical axis of rotation Place the reticle with adjustable front-to-back distance on object plane; adjust the width of slit to be minimized; use the microscope with intermediate visual angular magnification to observe and adjust it to the zero-line coincidence of slit image and reticle. As shown in Figure 1, the lighting system and the observation system rotate within the left (right) 45. When the rotation angle is α, if the slit image deviates from the reticle zero-line, read out the lateral deviation value (Δa)α from the reticle; then adjust the reticle so that the slit image coincides with the zero-line of the reticle. Record the axial distance Δa before-after adjustment of the reticle. The values of (Δa)α and Δa measured shall be in accordance with the regulations of No.5 in Table 1. 5.7 Confocal errors of observation system and lighting system at slit surface Use visual angular magnification to firstly adjust slit image to vertical position and record the clearest diopter-value of the slit image. When the rotating slit is tilted at any angle, use simple eye to observe; adjust the diopter loop of left (right) eyepiece to have clear slit; measure the displacement amount of left (right) eyepiece; use the same method to measure the diopter difference of left (right) eyepiece when it is at the highest and lowest visual angular magnification. The measured maximum displacement amount shall be in accordance with the provisions of No. 6 in Table 1. 5.8 Focus difference of left and right observation system Adjust the eyepiece diopter of slit-lamp microscope to zero and measure it at the highest visual angular magnification. Regard cross reticle as test object, adjust the focus of the cross division at left (right) observation system of slit-lamp microscope, and then use the right (left) observation system to adjust the focus of the cross division and read out the displacement amount. The result shall meet the requirements of No.7 in Table 1. 5.9 Eyepiece 5.9.1 Zero diopter error of eyepiece Use diopter-meter to test and the result shall meet the requirements of No.8 1) in Table 1. 5.9.2 Adjustment range of eyepiece interpupillary distance www.chinesestandard.net Buy True-PDF Auto-delivery. Page 12 of 15