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YY 0763-2009

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YY 0763-2009 英文版 320 购买 现货,9秒内自动发货PDF,有增值税发票。 医用内窥镜 照明用光缆 有效

   
标准编号: YY 0763-2009 (YY0763-2009)
中文名称: 医用内窥镜 照明用光缆
英文名称: Medical endoscopes - Fibre optical cables for lighting
行业: 医药行业标准
中标分类: C40
国际标准分类: 11.040
字数估计: 11,183
发布日期: 2009-12-30
实施日期: 2011-06-01
引用标准: GB 9706.1-2007
起草单位: 国家食品药品监督管理局杭州医疗器械质量监督检验中心
归口单位: 全国医用光学和仪器标准化分技术委员会
范围: 本标准规定了医用内窥镜照明用光缆的范围、术语和定义、要求、试验方法。本标准适用于内窥镜检查和手术所使用的可作为独立产品的普通照明用光缆。


YY 0763-2009
ICS11.040
C 40
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
YY 0763–2009
Medical endoscopes
Fibre optical cables for lighting
医用内窥镜
照明用光缆
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
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.
5.2.1.3 Output and testing device
The luminance meter and the other linear light detectors shall be designed with
accuracy within 1%. The detector dimensions shall satisfy that the included angle to
the centerline of the light output surface of the fibre optical cable is not greater than 6
degrees.
A device is so set up as to fix the end of the light output surface of the fibre optical
cable, able to clip the probe of the luminance meter, and able to let the probe of the
surface P), with the center of the light output surface of the fibre cable as the center
of the sphere (as Point O); and with a fixed value, R, as the radius. During movement,
the probe surface is always kept tangent with this spherical surface.
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
5.3.1.2 Aperture
It shall be a round and black aperture, with diameter less than that of the light input
surface of the tested fibre optical cable.
5.3.2 Steps
Select and set the spectrophotometer wavelength step to be 5 nm.
As shown in Figure 2, place the aperture at the light output opening to make
measurement of reference line.
As shown in Figure 3, keep the position of the aperture as shown in Figure 2. Adjust
the position of the light input surface of the measured fibre optical cable. Let the
optical cable. Measure the spectral transmission rate, t (λ) (where λ is arithmetic
sequence of ranging from 380 to 780, in nm, with tolerance of 5).
5.3.3 Calculation
Ranging from 420 nm to 720 nm, the absolute difference of the inconsistency of the
spectral transmission rate, Δt, is determined according to Equation (2).
minmax )()(t λλ tt −=∆ ... (2)
Where
λ is arithmetic sequence of ranging from 420 to 720, in nm, with tolerance of 5.
5.4 Calculation of light transmission rate
Standard Illuminant is determined according to Equation (3).
)()()(
)()()()(
λλλ
λλλλ
∆⋅⋅
∆⋅⋅⋅
VD
VtD
Where
λ is arithmetic sequence of ranging from 380 to 780, in nm, with tolerance of 5.
D65 (λ) is the relatively spectral radiance of D65 Standard Illuminant. The specific
value may be referred to ISO 10526. 1999 CIE S 005 “CIE Standard Illuminants for
Colorimetry”;
t (λ) is the spectral transmission rate of the measured fibre optical cable, measured
and obtained according to sub-clause 5.3.2;
V (λ) is the spectral luminous efficiency function of human eyes.
5.6.1.1 Flat steel base plate
horizontal and straightly.
5.6.1.2 Moveable steel flat plate
The plate dimensions shall ensure that forces are evenly applied onto a fibre cable of
100 mm long segment. Both edges in contact with the fibre optical cable being
measured shall be chamfered by a radius about 5 mm. The angle of chamfer is not
part of the 100 mm segment of the flat plate.
5.6.1.3 Load
The gross weight of the moveable flat plate and the load shall be 50 N. The load is
placed at the center of the moveable flat plate.
First, the fibre optical cable is placed naturally, horizontally and straightly. Then, the
moveable steel flat plate and load are gently and slowly placed onto the central
segment of the fibre optical cable, preventing it from being transversely moved. Let
the fibre optical cable to be pressed between the flat steel base plate and the
moveable flat plate. Under this condition for 1 minute, 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.
5.7 Tensile test
Gradually apply pulling force up to 20N at direction of fibre axis. Held for 5 min and
straight condition. 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.
5.8 Minimum bendable radius test
5.8.1 Device
It is a cylindrical spindle with smooth surface, with a diameter equal to the minimal
bendable radius, given by the manufacturer, of the fibre optical cable.
5.8.2 Steps
The central segment of the fibre optical cable is tightly wrapped on the spindle by one
optical cable’s natural minimal bending radius is greater than the given minimal
bendable radius after the external force is released. Let the fibre optical cable restore
to natural, horizontal and straight condition. 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.
References and Original Chinese Documents
[1] YY 0763-2009 Medical endoscopes Fibre optical cables for lighting.
   
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