YY 0763-2009 PDF English
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Medical endoscopes - Fibre optical cables for lighting
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YY 0763-2009: Medical endoscopes - Fibre optical cables for lighting---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/YY0763-2009
ICS11.040
C 40
PHARMACEUTICAL INDUSTRY STANDARD
YY 0763–2009
Medical endoscopes
Fibre optical cables for lighting
Issued on. DECEMBER 30, 2009
Implemented on. JUNE 01, 2011
Issued by. State Food and Drug Administration of the People’s Republic of
China
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Terms and definitions... 4
4 Requirements... 5
5 Test method... 7
References and Original Chinese Documents... 17
Foreword
This standard was proposed by and under jurisdiction of the National Technical
Committee of Optics & Optical Instruments of Standardization Administration of
China (SAC/TC103/SC1).
The drafting organization of this standard is State Food and Drug Administration
Hangzhou Centre for Medical Devices Quality Supervision and Testing.
Chief drafting staffs of this standard include Yan Qinglai, Jia Xiaohang, Ma Jun and
Zhang Qinyuan.
Medical endoscopes — Fibre optical cables for lighting
1 Scope
This standard specifies the scope, terms and definitions, requirements, and test
methods of fibre optical cables for lighting of the medical endoscopes.
This standard applies to fibre optical cables, which may be used as independent
products, used for normal lighting of examination and operation together with medical
endoscopes.
NOTE Normal fibre optical cables refer to those not for special purpose of application.
2 Normative references
The following standards contain provisions which, through reference in this standard,
constitute provisions of this standard. For dated references, subsequent
amendments (excluding any correction) or revisions are not applicable to this
standard. However, parties who mutually agree to this standard are encouraged to
investigate the possibility of applying the most recent editions of the normative
documents indicated below. For undated references, the latest edition of the
respective normative document is applicable to this standard.
GB 9706.1 – 2007 Medical electrical equipment — Part 1.General requirements
for safety (idt IEC 60601-1.1988 + A1.1991 + A2.1995)
3 Terms and definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
light input surface
the effective light transmission surface of the joint between fibre optical cable and
cool light-illuminator.
3.2
light output surface
the effective light transmission surface of the joint between fibre optical cable and
medical endoscope.
3.3
initial condition
the condition that the fibre optical cable has been never inspected or tested under the
applied force in accordance with this standard; and is placed naturally, horizontally
and straightly.
4 Requirements
4.1 Dimensions
4.2 Optical performance
4.2.1 Light output angle
In the instructions for use, the manufacturer shall state the nominal value of the light
output angle of the fibre optical cables, with permissible tolerance of±10%.
4.3.1 Torsion
Under torsional condition, the light transmission performance of the fibre optical
cable shall not be less than 90% of performance of initial condition.
4.3.2 Momentary flattening
Under momentarily flattened condition, the light transmission performance of the
fibre optical cable shall not be less than 90% of initial-condition.
4.3.3 Tension
After axially tensional test, the light transmission performance of the fibre optical
cable shall not be less than 90% of performance of initial condition.
4.3.4 Minimum bendable radius
In the instructions for use, the manufacturer shall state the minimum bendable radius
of the fibre optical cable. After the fibre optical cable is tested by bent to the minimum
bendable radius, its light transmission performance shall not be less than 90% of
performance of initial condition.
4.4 General requirements
The light input surface and light output surface of the fibre optical cable shall be
bright and clean, smooth and neat, and free of notch. The external surface shall be
continuously smooth; and free of sharp edge, burr, cracking and other defects which
may possibly result in hazard to human body.
4.5 Disinfection
Repetitively disinfected for 20 times according to the instructions for use, the light
transmission performance of the fibre optical cable shall not be less than 90% of
performance of initial condition.
4.6 Dieletric strength
After the moist pre-treatment, the fibre optical cable is tested for 1 min under an
effective sinusoidal 1,500 VAC 50 Hz voltage which is applied to the end of the light
input surface and the end of the light output surface. There shall be no breakdown
and flashover.
4.7 Designation
The fibre optical cable shall be designated with classification mark of BF type, in
accordance with those specified in sub-clause 6.1 of GB 9706.1 – 2007.
5 Test method
5.1 Dimensions
General measuring tools shall be used for measurement.
5.2 Determination of light output angle
5.2.1.1 Light illuminator
At spectrum ranging from 380 nm to 780 nm, the light illuminator to be used shall be
continual, stable, spectrum-rich, and capable of adjusting the output of light intensity.
The stability of the light intensity output shall be within ±2%.
5.2.1.2 Injection device
5.2.1.2.1 Integrating sphere
For the integrating sphere to be used, the total area of the opening holes shall not
exceed 10% of the whole spherical area inside the sphere.
5.2.1.2.2 Cosine radiation panel
A transmission-type cosine radiation panel shall be used. The luminance
unevenness at each point and in any direction shall not be greater than 5%. Those
opening holes, their area bigger than the integrating sphere, shall be placed at the
light output opening of the integrating sphere; closely against the light input surface;
and perpendicular to the mechanically positioning axis of the light input surface of the
fibre optical cable.
5.2.2 Ambient conditions
Under the testing environment, the dark luminance shall be controlled not greater
than 1 lx.
5.2.3 Steps
Fix the end of the light input surface of the fibre optical cable. Let the cosine radiation
panel be placed against the light input surface of the fibre optical cable. Adjust the
illuminator to appropriate light intensity.
5.2.4 Calculation
The average light output angle,θ, is determined according to Equation (1).
5.4 Calculation of light transmission rate
Ranging from 380 nm to 780 nm, the light transmission rate, T, corresponding to D65
Standard Illuminant is determined according to Equation (3).
5.5 Torsional test
5.5.1 Determination of luminous flux output
5.6 Momentarily flattening test
5.6.1 Devices
They are shown in Figure 5.
5.9 Test of impact due to falling
5.9.1 Devices
5.9.1.1 Special wooden board for testing
It is a 50-mm-thick hard wooden board (for example, made of hard wood with density
greater than 700 kg/m3).
5.10 General required inspections
They include visual observation, hand-feeling, and operating inspection.
5.11 Disinfection test
The fibre optical cable is repetitively disinfected for 20 times according to the method
specified in the instructions for use. Measure the luminous flux output in accordance
with those specified in sub-clause 5.5.1.Compare it to the measured value from
sub-clause 5.5.2.
5.12 Dielectric strength test
The fibre optical cable is moist-pretreated in accordance with those specified in
sub-clause 4.10 of GB 9706.1-2007, and then tested in accordance with sub-clause
20.4 of GB 9706.1-2007.
5.13 Check of marking
Test shall be carried out in accordance with sub-clause 6.1 of GB 9706.1-2007.
References and Original Chinese Documents
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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