YY 0065-2016Ophthalmic instruments - Slit-lamp microscopes (English PDF)

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.

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.

4 Requirements

5 Test methods

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 alpha, if the slit image deviates from the reticle zero-line, read out the lateral deviation value (deltaa)alpha from the reticle; then adjust the reticle so that the slit image coincides with the zero-line of the reticle. Record the axial distance deltaa before-after adjustment of the reticle. The values of (deltaa)alpha and deltaa measured shall be in accordance with the regulations of No.5 in Table 1.