YY 0792.2-2010Ophthalmic instruments - Endoilluminators - Part 2: Fundamental requirements and test methods for optical radiation safety (English PDF)
眼科仪器 眼内照明器 第2部分：光辐射安全的基本要求和试验方法
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
December 27, 2010
Implementation date
June 1, 2012
Scope
YY 0792.2-2010 is the English-translated version of 眼科仪器 眼内照明器 第2部分：光辐射安全的基本要求和试验方法.
YY 0792.2-2010 is the Chinese standard "Ophthalmic instruments - Endoilluminators - Part 2: Fundamental requirements and test methods for optical radiation safety".
Its scope clause reads: This part of YY 0792 specifies the optical radiation safety requirements for intraocular lasers. The intraocular illuminator is used for eye surgery during ophthalmic surgery Ming use.
This section does not apply to other active and passive ophthalmic devices and surgical microscopes. Its clauses include normative reference documents; terms and definitions.
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Document preview — YY 0792.2-2010
National Standard of the People's Republic of China
- ICS
- 11.040.70
- Classification
- C40
Issued by: National Medical Products Administration
Contents
- Preface
- 1 Scope
- 2 normative reference document
- 3 Terms and definitions
- 4 requirements
- 6 Information provided by the manufacturer
- 7 logo
- Appendix A (normative) Retinal safety analysis Spectral weighting function
- Appendix B (Normative Appendix) Information provided by the manufacturer to the user
- Appendix C (informative) Method of measuring light intensity
1 Scope
This part of YY 0792 specifies the optical radiation safety requirements for intraocular lasers. The intraocular illuminator is used for eye surgery during ophthalmic surgery
Ming use.
This section does not apply to other active and passive ophthalmic devices and surgical microscopes.
2 normative reference documents
The terms of this document are incorporated by reference in this section and become part of this section. Whichever is the date of the reference file, which is followed by all (Excluding corrigenda) or revisions do not apply to this part, however, encourage parties to reach an agreement under this section
Whether you can use the latest version of these files. For undated references, the latest edition applies to this section.
GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
3 terms and definitions
The following terms and definitions apply to this part of YY 0792.
3.1 Aperture
Usually a circular through-hole through which light can enter an optical system.
3.1.1 Effective aperture
Through aperture
Limiting the aperture of the amount of light projected onto the ocular retina.
Note. For non-intangible and non-circular through-aperture, equivalent to the straight-through circular aperture treatment; for porous perforated aperture, according to the area of the equivalent of the circle
Shaped aperture treatment.
3.1.2 Numerical aperture
The numerical aperture of the fiber is represented by the product of the refractive index of the medium in which the object is illuminated and the sinusoidal sinusoidal value of the illumination cone.
NA = n 'sinu'
Where.
n '--- the refractive index of the medium in which the object is illuminated;
u '--- half of the light cone angle.
3.1.3
The aperture is exitingaperture
The light guide portion of the intraocular illuminator, the light emitted by the intraocular illuminator light source, is output through the light guide.
3.2 Intraocular illuminator endoiluminator
A device consisting of an intraocular illuminator light source and an optical fiber synthetic intraocular illuminator light guide is intended to be inserted into the eye for eye […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.
Referenced standards
Normative references
IEC 60601
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