YY/T 0932-2014 PDF EnglishUS$160.00 · In stock · Download in 9 seconds
YY/T 0932-2014: Medical luminaries. Medical head-mounted luminaires Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
YY/T 0932-2014: Medical luminaries. Medical head-mounted luminaires---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0932-2014YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040 C 40 Medical luminaires - Medical head-mounted luminaires ISSUED ON: JUNE 17, 2014 IMPLEMENTED ON: JULY 01, 2015 Issued by: China Food and Drug Administration Table of ContentsForeword ... 3 1 Scope ... 4 2 Normative references ... 4 3 Terms and definitions ... 4 4 Requirements ... 5 5 Test methods ... 6 6 Marking ... 8 Medical luminaries - Medical head-mounted luminaries1 ScopeThis Standard specifies the requirements and test methods of head-mounted luminaries. Medical head-mounted luminaries are clinically worn on the doctor's head for diagnostic examination and illumination of patients.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 5702-2003, Methods of measuring the color of light sources GB/T 7922-2008, Method of measuring the color of light sources GB 9706.1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance GB/T 14710-2009, Environmental requirement and test methods for medical electrical equipment GB/T 16886.1-2011, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process GB/T 16886.5-2003, Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity GB/T 16886.10-2005, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity GB/T 20145-2006, Photobiological safety of lamps and lamp systems JB/T 7403-1994, Illuminance meter ISO 15004-2: 2007, Ophthalmic instruments -Fundamental requirements and test methods - Part 2: Light hazard protection3 Terms and definitionsFor the purpose of this document, the following terms and definitions apply. 3.1 medical head-mounted luminaries Lighting device worn on a doctor's head for diagnostic examination of patients.4 Requirements4.1 Optical requirements 4.1.1 Illuminance The manufacturer shall specify the illumination at the specified distance from the light outlet, with a tolerance of ±20%. 4.1.2 Spot diameter The manufacturer shall specify the spot diameter at the specified distance from the light outlet, with a tolerance of ±10%. 4.1.3 Color rendering index The color rendering index of emitted light shall be ≥ 85. 4.1.4 Color temperature The color temperature of emitted light shall be between 3 000 K ~ 6 700 K. 4.2 Headband adjustment range (if applicable) The adjustment range of headband shall be no less than 520 mm ~ 640 mm. 4.3 Brightness adjustment function The light output shall be adjustable from at least 10% of the maximum value to the maximum value, and an indication of the relative light intensity ratio or intensity change direction corresponding to the maximum light intensity shall be given. 4.4 Material biocompatibility Application site materials in direct contact with the operator’s skin, such as headbands, shall be proven to be biocompatible in one of the following ways: a) According to the biological evaluation principles of GB/T 16886.1-2011, the following requirements shall be met: -- No cytotoxicity; -- No delayed-type hypersensitivity. Emphasize the light of the light source to the maximum position; respectively measure the spot diameter in horizontal direction and vertical direction at the distance specified by the manufacturer, and calculate the average value. 5.1.4 Color rendering index 5.1.4.1 Equipment For the spectral radiation measurement system, the spectral measurement range is not less than 380 nm ~ 780 nm, the wavelength resolution is not more than 2 nm, and the relative spectral radiance difference is not more than 1%. 5.1.4.2 Steps The wavelength step of the spectral radiation system is selected at 5 nm. Measure the relative spectral power distribution S(λ) of the light source when the light intensity setting of the light source is adjusted to the maximum value. 5.1.4.3 Calculation It shall be carried out according to the provisions of GB/T 5702-2003 and GB/T 7922- 2008. 5.1.5 Correlated color temperature According to the relative spectral power distribution S (λ) of the light source measured in 5.1.3.2, calculate the color coordinates u and v according to GB/T 5702-2003, and then find the corresponding correlated color temperature according to the blackbody radiation trajectory in the uv chromaticity coordinate diagram. 5.2 Headband adjustment range Check with a general measuring tool. 5.3 Brightness adjustment function Proceed according to the method of 5.1.2. 5.4 Biocompatibility of materials 5.4.1 General The following materials can be finished parts or test pieces processed by the same method. The shape and size of test materials shall be prepared and treated according to the test requirements. 5.4.2 Cytotoxicity test ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of YY/T 0932-2014 be delivered?Answer: The full copy PDF of English version of YY/T 0932-2014 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of YY/T 0932-2014_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0932-2014_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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