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YY 1081-2011Medical endoscopes—Endoscope supply units—Cold light sources (English PDF)

医用内窥镜 内窥镜功能供给装置 冷光源

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

December 31, 2011

Implementation date

June 1, 2013

Scope

YY 1081-2011 is the English-translated version of 医用内窥镜 内窥镜功能供给装置 冷光源.

YY 1081-2011 is the Chinese pharmaceutical industry standard for the cold light source used as the supply device of an endoscope in examination and surgery.

It sets the requirements for such light sources, covering the luminous flux delivered to the light guide and its stability, the colour temperature and the spectrum, the heat at the distal end, the lamp and its life and the warning that it is failing, the fan and the noise, and the electrical safety.

Other cold light sources may adopt it so far as it suits them. Issued on 31 December 2011, it has applied since 1 June 2013.

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Document preview — YY 1081-2011

National Standard of the People's Republic of China

Replacing
YY 91081-1999

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword3
  • 1 Scope4
  • 2 Normative References4
  • 3 Terms and Definitions4
  • 4 Requirements5
  • 5 Test Methods7
  • 6 Inspection Rules13
  • Appendix A14

Foreword

This Standard was drafted in accordance with provisions given in GB/T 1.1-2009.

From the date of implementation of this Standard, YY 91081-1999 "Medical endoscope - Cold light source" shall be abolished.

1 Scope

This Standard specifies the requirements for cold light sources.

This Standard applies to cold light sources which are used as a function of supply device in endoscope inspection and surgery, other cold light sources can selectively adopt this document according to the applicability.

2 Normative References

For the application of this document, the following documents are essential. For dated references, only the dated editions are applicable to this document. For undated references, the latest editions (including any amendments) apply to this document.

GB/T 5702-2003 Light source color rendering evaluation method

GB/T 7922-2008 Color of light source measurement methods

GB 9706.1-2007 Medical electrical equipment. Part 1: General requirements for safety

GB 9706.19-2000 Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment

3 Terms and Definitions

The following terms and definitions apply in this document.

3.1 Light input surface of the optical fiber cable

Effective light-through surface at the connection terminal between the optical fiber cable and the cold light source.

3.2 Reference plane

The coincide plane between the light input surface of the optical fiber cable and the cold light source which is connected with adaptation cable.

4 Requirements

4.1 Structure

The manufacturer shall provide the structure of cold light source in any viable form, including the characteristics of applicable bulb. And it shall clearly indicate if there is guided optical beam contained in the structure.

The product provided by manufacturer shall be consistent with the described structure.

4.2 Spectral properties

spectrums, it shall provide the distribution and matching ratio of the corresponding spectrums.

4.2.4 Spectral characteristics of cold light source of special spectrum use

For cold light source of special spectrum use, the manufacturer shall provide the spectral characteristics of cold light source, including the spectrum's main peak value, the nominal value and tolerance of FWHM (full width at half maximum). Cold light source shall comply with the spectral characteristics.

4.3 Illumination uniform performance of reference window

4.3.1 Illumination uniformity

The manufacturer shall provide the nominal value of illumination uniformity of reference window for cold light source used for rigid endoscope. the actual measured value shall not be greater than 1.05 times of the nominal value.

4.4 Radiation performance

4.4.1 Total output luminous flux

The manufacturer shall provide the nominal value of the total output luminous flux, tolerance of -10%, the upper limit does not count.

4.7 Safety measures of anti-fault

For cold light source used for surgery, it shall have safe measures of anti-fault, it may adopt methods such as providing indication of life-span of bulbs or providing indication of changing bulbs, or the use of spare bulbs.

5 Test Methods

5.1 Determination of CRI

5.1.2 The relative spectral power distribution S(lambda) of cold light source is obtained according to the measurement of 5.1.2, CALCULATE the ration of output radiation flux and luminous flux according to photometry principle.

5.1.1 Device

Spectroradiometer system. Spectral measurement range shall not be less than 380 nm - 780 nm, the wavelength resolution shall not be greater than 1.5.nm, the relative spectral radiance difference shall not be greater than 1%.

5.1.3 Calculation

It shall be carried out according to the provisions of GB/T 5702-2003 and GB/T 7922-2008.

5.2 Calculation of correlated color temperature

The relative spectral power distribution S(lambda) of cold light source is obtained according to the measurement of 5.1.2, CALCULATE color coordinates u, v according to GB/T 5702-2003, Then FIND the corresponding correlated color temperature according to blackbody radiation locus in uv chromaticity coordinates graph.

5.3 Calculation of radiation flux ratio of red, green and blue light

According to the correlated spectral power distribution S(lambda) of cold light source obtained from the measurement of 5.1.2, Phier, Phieg, Phieb shall be determined by formula (1), (2), (3) respectively.

5.6 Determination of illumination uniformity

5.6.1 Device
5.6.1.2 Positioning device

It shall be able to position the light input surface of standard single fiber for measurement, to ensure the light input surface to be located on the reference window of cold light source, and it can meet the positioning requirements of measurement positions selected on reference window.

5.6.2 Steps
5.6.2.1 Preparations

CONTROL the test environment, the dark intensity shall not be more than 1 lx.

CONTROL the power supply of light source to remain stable at the nominal voltage, the voltage shall be monitored, the voltage stability shall be controlled within ± 2%.

Light source shall be fully preheated, time shall not be less than 30 min.

The intensity setting of cold light source shall be adjusted to the maximum.

5.8.2.2 Measurement of luminous flux

USE positioning device to position the light input surface of standard single fiber onto the reference window of cold light source, and LET the center of light input surface to coincide with the center of reference window of cold light source; and center axis to be perpendicular to the plane of reference window.

5.9 Electrical safety performance test

It shall be conducted in accordance with the specified methods in GB 9706.1-2007 and GB 9706.19-2000.

6 Inspection Rules

Inspection rules shall be based on product features and decided by manufacturer. […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.

Referenced standards

Similar standards

Editions of YY 1081

EditionTitleRevisionStatus
YY 1081-2011Medical endoscopes—Endoscope supply units—Cold light sourcescurrent editionCurrent
YY 91081-1999Medical endoscopes—Endoscope supply units—Cold light sourcesprevious editionSuperseded

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