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YY/T 1146-2016 English PDF

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YY/T 1146-2016: Measurement methods of illuminance for medical optical instruments
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Basic data

Standard ID YY/T 1146-2016 (YY/T1146-2016)
Description (Translated English) Measurement methods of illuminance for medical optical instruments
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C40
Classification of International Standard 11.040.70
Word Count Estimation 5,575
Date of Issue 2016-03-23
Date of Implementation 2017-01-01
Older Standard (superseded by this standard) YY 91146-1999
Regulation (derived from) Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies) State Food and Drug Administration

YY/T 1146-2016: Measurement methods of illuminance for medical optical instruments

---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.
Measurement methods of illuminance for medical fiber instruments ICS 11.040.70 C40 People's Republic of China Pharmaceutical Industry Standard Replacing YY 91146-1999 Methods of illumination test for medical optical instruments 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The release of this document The Agency does not assume responsibility for identifying these patents. This standard replaces YY 91146-1999 "medical optical instrument illumination test method", compared with YY 91146-1999, in addition to editorial The main technical changes are as follows. --- increase the normative reference document JJG245-2005 light meter verification procedures; - Added the terms and definitions of "illuminance", "light field center illumination", "light field uniformity" (see 3.1, 3.2, 3.3); --- Removed Appendix A Medical Optical Instrument Illumination Test Record Table. This standard is proposed by the State Food and Drug Administration. This standard is nationalized by the National Standardization Subcommittee for Medical Optical Instruments (SAC/TC103/SC1). The drafting of this standard unit. Zhejiang Medical Device Testing Institute. The main drafters of this standard. Wang Jingtao, Jia Xiaohang, He Tao, Qi Weiming, Peng Jianhua. This standard replaces YY 91146-1999. YY 91146-1999 the previous version of the release of the situation. --- WS2-311-84; --- YY 91146-1999. Methods of illumination test for medical optical instruments

1 Scope

This standard is applicable to ophthalmic optical instruments with objective lens, eyepiece and lighting fixture illumination test, other visual medical optical instrument illumination test The method may be performed according to the applicability reference. Ophthalmic optical instrument Illumination test, refers to the instrument lighting device irradiation in the surface of the light field center illumination test and/or surface light field uniformity test.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. Standard for Verification of Illumination of JJG245-2005

3 terms and definitions

The following terms and definitions apply to this document. 3.1 Illuminance iluminance The amount of luminous flux on the face irradiated to the surface at a point is divided by the area of the face. 3.2 Center center illuminance centraliluminanceoflightfield Ec The illuminance of the geometric center of the surface light field. 3.3 Uniformity of light field uniformity of light field The ratio of the illuminance of the edge of the surface to the center of the light field.

4 test method

4.1 Instruments and equipment 4.1.1 The test illuminometer shall meet at least the requirements of the secondary illuminometer in JJG245-2005. 4.1.2 The effective diameter of the illuminance meter receiver shall not be greater than 1/3 of the diameter of the light field (or diagonal length) when the object field uniformity test is performed. 4.2 Test procedure 4.2.1 ophthalmic optical instrument illumination test should be in the ambient light is not greater than 1lx, no significant impact on the test under the conditions. 4.2.2 measured instrument supply voltage should be consistent with the nominal voltage, voltage stability should be controlled within ± 2%. 4.2.3 Test should be carried out after the light source is stable, the warm-up time is not less than 30min.

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