YY 0792.2-2010 English PDF

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YY 0792.2-2010: Ophthalmic instruments. Endoilluminators. Part 2: Fundamental requirements and test methods for optical radiation safety

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0792.2-2010	459	Add to Cart	3 days	Ophthalmic instruments. Endoilluminators. Part 2: Fundamental requirements and test methods for optical radiation safety

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YY/T 0758   YY 0762   YY/T 0842   YY/T 0787   YY 0861   YY 0792   

Basic data

Standard ID: YY 0792.2-2010 (YY0792.2-2010)
Description (Translated English): Ophthalmic instruments. Endoilluminators. Part 2: Fundamental requirements and test methods for optical radiation safety
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C40
Classification of International Standard: 11.040.70
Word Count Estimation: 13,164
Date of Issue: 2010-12-27
Date of Implementation: 2012-06-01
Quoted Standard: GB 9706.1
Adopted Standard: ISO 15752-2000, MOD
Regulation (derived from): State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the eye illuminator optical radiation safety requirements. The eye in the eye illuminator for eye surgery lighting. This section does not apply to other active and passive devices and ophthalmic surgical microscope.

YY 0792.2-2010: Ophthalmic instruments. Endoilluminators. Part 2: Fundamental requirements and test methods for optical radiation safety

---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.
Ophthalmic instruments.Endoilluminators.Part 2. Fundamental requirements and test methods for optical radiation safety ICS 11.040.70 C40 People's Republic of China Pharmaceutical Industry Standard Ophthalmic instruments intraocular luminaire Part 2. basic requirements for the safety of optical radiation and experiment method Part 2. Fundamentalrequirementsandtestmethods foropticalradiationsafety (ISO 15752..2000, MOD) 2010-12-27 release 2012-06-01 implementation State Food and Drug Administration issued Directory Preface III 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 requirements 2 Method for determination of spectral irradiance 3 6 Information provided by the manufacturer 3 7 logo 4 Appendix A (normative) Retinal safety analysis Spectral weighting function 5 Appendix B (Normative Appendix) Information provided by the manufacturer to the user 7 Appendix C (informative) Method of measuring light intensity

Foreword

YY 0792 "ophthalmic instrument eye illumination device" is divided into two parts. - Part 1. General requirements; - Part 2. Basic requirements and test methods for the safety of optical radiation; This part is part 2 of YY 0792. This part of the revised use of ISO 15752..2000 "ophthalmic instruments, intraocular lighting, optical radiation safety of the basic requirements and test methods" (English version). The main differences between this part and ISO 15752..2000 are as follows. a) IEC 60601-1..1998 and IEC 60601-1 appearing in ISO 15752..2000 to correspond to our national standard GB 9706.1-2007 and GB 9706.1. b) 3.1.1 Terminology. "Effective pore size" is supplemented by the same term as the "light aperture", which complements the equivalent pore size method. c) an increase of the 4.3.3 setpoint deviation clause; d) 4.5.1 supplemented the limitation of the provisions of the increase in the form of instructions and additional instructions. This part is redrafted in accordance with ISO 15752..2000, and the modifications and technical differences have been incorporated into the text and in which they are The blanks of the terms are marked with a vertical single line (|). Appendix A and Appendix B of this section are normative and Appendix C is an informative appendix. This part is proposed and assigned by the National Standardization Subcommittee for Medical Optics and Instruments (SAC/TC103/SC1). This part of the drafting unit. the State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center. This part of the main drafters. Jia Xiaohang, Wen Yan, Wang Jingtao. Ophthalmic instruments intraocular luminaire Part 2. basic requirements for the safety of optical radiation and experiment method

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 effectiveaperture 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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