YY/T 0922-2014 PDF English
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Medical Endoscopes - Endoscope Accessories - Bridges
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YY/T 0922-2014: PDF in English (YYT 0922-2014) YY/T 0922-2014
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PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.99
C 40
Medical Endoscopes -
Endoscope Accessories - Bridges
ISSUED ON: JUNE 17, 2014
IMPLEMENTED ON: JULY 1, 2015
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 4
4 Requirements... 5
5 Test Methods ... 8
6 Inspection Rules ... 10
Medical Endoscopes -
Endoscope Accessories - Bridges
1 Scope
This Standard specifies the terms, definitions, requirements and test methods of
bridges.
This Standard is applicable to bridges, which are used for endoscope import for
medical purposes.
2 Normative References
The following documents are indispensable to the application of this Standard. In terms
of references with a specified date, only versions with a specified date are applicable
to this Standard. In terms of references without a specified date, the latest version
(including all the modifications) of is applicable to this Standard.
GB/T 14233.1-2008 Test Methods for Infusion, Transfusion, Injection Equipment
for Medical Use - Part 1: Chemical Analysis Methods
GB/T 14233.2-2005 Test Methods for Infusion, Transfusion, Injection Equipment
for Medical Use - Part 2: Biological Test Methods
GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and
Testing within a Risk Management Process
YY/T 0149-2006 Medical Instruments of Stainless Steel - Test Methods of
Corrosion Resistance
3 Terms and Definitions
The following terms and definitions are applicable to this Standard.
3.1 Endoscope Accessory
Endoscope accessory refers to accessory, which are indispensable to and/or suitable
for endoscope to implement the expected purposes of endoscope; or make it
convenient for the implementation of the expected purposes of endoscope; or improve
the expected purposes of endoscope; or increase the additional functions of
endoscope.
shall prevail in all the tests.
In terms of materials which have already been proved to be applicable, if it can be
proved that the subsequent manufacturing process of the materials would not generate
biosafety hazards, repeated biological tests may be unnecessary.
NOTE 1: in design, if instrument materials have demonstrable history of usage in specific
application, or relevant material and/or instrument information may be obtained
from other aspects, then, it may be believed that the materials have already been
proved to be applicable before.
NOTE 2: in terms of metal materials, if medical metal materials with an applicable range
of application in national or industrial standards are adopted, repeated biological
tests may be unnecessary.
4.2 Dimensions
4.2.1 Total length
The nominal value tolerance of the total length of bridge shall be: ± 3% or 1 mm.
4.2.2 Minimum main channel width
The minimum width of main channel shall be not less than the nominal value.
4.3 Coordination
4.3.1 Locking, inserting and disassembly
Locking (if it is equipped with a locker), inserting and disassembly, which are jointly
coordinated by bridge, sheath, endoscope or obturator, shall comply with the following
requirements:
a) After the coordination, it shall be able to be locked; the locking shall be reliable;
b) Inserting shall be relaxing; disassembly shall be relaxing and convenient.
4.3.2 Positioning and sealing
After the joint coordination of bridge, sheath or endoscope, it shall satisfy the following
requirements:
a) After it is properly inserted, the positioning shall be reliable; there shall be no
loosening;
b) Except when the manufacturer claims that there is no requirement for sealing,
after it is properly inserted, it shall be properly sealed. In water permeability test,
within 1 min, permeated water shall not exceed 5 drops.
4.8.1 Sterility
If bridges are disposable, they shall be sterile.
4.8.2 Ethylene oxide residue
If the disposable bridges adopt ethylene oxide for sterilization, ethylene oxide residue
shall be not more than 10 μg/g.
5 Test Methods
5.1 Materials
5.1.1 Chemical composition of metal materials
Chemical composition of metal materials shall be tested through the method of
appropriate precision.
5.1.2 Biocompatibility
It is recommended that biological tests shall adopt relevant parts in GB/T 16886.
5.2 Dimensional Measurement
5.2.1 Equipment
Standard measuring tools, measuring instruments or other tools with equivalent
precision shall be adopted for measurement test.
5.2.2 Environmental conditions
Room temperature: 23 °C ± 5 °C.
5.2.3 Procedure
The procedure of measurement shall comply with routine methods.
5.3 Inspection of Coordination
5.3.1 Locking, inserting and disassembly test
5.3.1.1 Equipment
Standard dynamometer or other equivalent tools.
5.3.1.2 Environmental conditions
The test shall be conducted under room temperature.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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