YY 0068.2-2008 PDF in English
YY 0068.2-2008 (YY0068.2-2008) PDF English
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Medical endoscopes. Rigid endoscope. Part 2: Mechanical properties and test methods
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YY 0068.2-2008: PDF in English YY 0068.2-2008
YY
ICS 11.040
C 40
Pharmaceutical Industry Standard
of the People’s Republic of China
Partially replacing YY 0068-1992
Medical endoscopes – Rigid endoscope –
Part 2. Mechanical properties and test methods
ISSUED ON. OCTOBER 17, 2008
IMPLEMENTED ON. JUNE 1, 2010
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Requirements ... 7
5 Test methods ... 10
Foreword
The clause 5 of this Part are recommended.
YY 0068 Medical endoscopes – Rigid endoscope is divided into four parts.
— Part 1. Optical properties and test methods;
— Part 2. Mechanical properties and test methods;
— Part 3. Marking and instruction manual;
— Part 4. Fundamental requirement.
This Part is the Part 2 of YY 0068.
This Part corresponds to ISO 8600-1.2005 Optics and photonics – Medical
endoscopes and endotherapy devices – Part 1. General requirements, and ISO
8600-4.1997 Optics and optical instruments – Medical endoscopes and certain
accessories – Part 4. Determination of maximum width of insertion portion.
Furthermore, this Part is not equivalent to the degree of consistency specified
in the ISO 8600-1.2005 and ISO 8600-4.1997.
The terms and definitions of this Part are consistent with the concepts described
in ISO 8600-6.2005 Optics and photonics – Medical endoscopes and
endotherapy devices – Part 6. Vocabulary.
The differences between this Part and the parts of the ISO 8600 are as follows.
— DIVIDE the parts of the standard according to the characteristics of rigid
endoscopes described in this Standard;
— SUPPLEMENT the contents of working length, dimensions of the
eyepiece cover, coordination, encapsulation, strength and stiffness,
connection, and external surface quality of the insertion portion.
This Part replaces the requirements and relevant test methods specified in the
Sections 4.3, 4.6, 4.7, 4.8 and 4.11 of the YY 0068-1992. From the date of the
implementation of this Part, the replaced clauses in the YY 0068-1992 will be
abolished at the same time.
This Part shall be used together with GB 11244-2005. The relevant
requirements are the supplement to the relevant requirements specified in the
GB 11244-2005.
This Part was proposed by and shall be under the jurisdiction of the Technical
Medical endoscopes – Rigid endoscope –
Part 2. Mechanical properties and test methods
1 Scope
This Part of YY 0068 specifies the mechanical property requirements and test
methods of the rigid endoscopes.
This Part applies to the rigid endoscopes for medical purposes.
2 Normative references
The provisions in the following documents become the provisions of this Part
through reference in this Part of the YY 0068. For dated references, the
subsequent amendments (excluding corrections) or revisions do not apply to
this Part. However, parties who reach an agreement based on this Part are
encouraged to study if the latest versions of these documents are applicable.
For undated references, the latest versions apply to this Part.
YY 0068.1 Medical endoscopes – Rigid endoscope – Part 1. Optical
properties and test methods
3 Terms and definitions
The terms and definitions established in the YY 0068.1 and the following ones
are applicable to this Part of the YY 0068.
3.1 Endotherapy device
It refers to the medical device entering into the human body’s natural orifice or
surgical incision via the channel which is the same with or different from that of
the endoscope during the endoscopic surgery, for the purposes of examination,
diagnosis or treatment.
Note 1. The endotherapy devices include some devices guiding the insertion of the endoscopes or
endotherapy devices, such as catheter, trocar or sliding pipe. The endotherapy devices also
include the devices entering from different human bodies’ incisions which are different from those
of the endoscope, and used under the observation of the endoscope for security reasons.
Note 2. The term “endoscopic accessories” is used in the Section 2.1.102 of the GB 9706.19-2000.
4.3 Encapsulation
4.3.1 Fog layer
For the endoscopes containing optical elements, CLEAN and DRY the sealed
interior. After the sudden change test from low temperature to high temperature,
there shall be no blurry field of view.
4.3.2 Encapsulation reliability
The endoscopes containing optical elements shall be able to bear the following
encapsulation test without losing efficiency.
1) CONDUCT hydrostatic test for 12h at 1m under water;
2) REPEAT to conduct the test for 20 times according to the sterilization or
disinfection methods specified by the manufacturer.
Note. Section 4.3.2 b) of this Part does not apply to the disposable endoscopes.
4.4 Strength and stiffness
If the dimensions of the cross section of the endoscope’s insertion portion is too
small, or the slenderness ratio is too large, and thus it is easy to be damaged,
the manufacturer shall give a warning description in the accompanying files. In
the meantime, GIVE an indication of the vulnerable and frangible portions, and
CLAIM the maximum bearable force or torque. CONDUCT the test to verify this
force or torque. The test force or torque shall not be less than the declared
value.
If the endoscope’s insertion portion allows to be bent moderately, the
manufacturer shall describe the allowable bending portion, maximum deflection,
force under the maximum deflection, and test methods in the accompanying
files.
Note. The applicability determination depends on the continuous clinical feedback, or manufacturer’s self-
declaration, or senior’s evaluation.
4.5 Connection
For the connecting portions constituted by the endoscopes, if using the tight fit
method for connection, there shall be no visible gaps at the fitting locations; if
using the welding method for connection, there shall be no uneven bumps, de-
soldering, surfacing, or significant pitting at the welds; if using the gluing method
for connection, there shall be no overflow or apparent gel at the gluing locations,
and there shall be no glue marks on other portions.
5.2 Coordination inspection
5.2.1 Tests for locking, insertion and demolition
5.2.1.1 Equipment
Standard tension meter, or other equivalent tools.
The minimum reading of the measuring tool shall be greater than 10% of the
required minimum reading.
5.2.1.2 Environmental conditions
At room temperature.
5.2.1.3 Procedures
5.2.1.3.1 USE a special fixture or soft noose to connect the terminal of the
eyepiece cover or the leading-out terminal of the endoscope.
5.2.1.3.2 The measurement procedures shall be in accordance with the
routine method. The test’s point of action shall be located on the mechanical
axis or extension line of the specimen. The force direction shall parallel to this
mechanical axis.
5.2.2 Tests for positioning and coordination
Environmental conditions. at room temperature.
VERIFY the test described in the Section 4.2.2 a) via the operations coordinated
with the inspection.
LOCK the coordination BETWEEN endoscope AND sheath as well as
BETWEEN endoscope AND bridge and sheath. CONDUCT the test described
in the Section 4.2.2 b) afterwards. USE a casing pipe to tighten the distal sheath.
SEAL at the juncture. USE a rubber hose to connect the casing head with the
water source whose differential pressure is not lower than 1m water column.
TURN on the water column. LAST for 1min. OBSERVE the leakage situation
within 1min at the location where the endoscope coordinates with the sheath,
or with the bridge and sheath.
5.3 Encapsulation inspection
5.3.1 Fog layer test
5.3.1.1 Equipment
One temperature regulating water bath. The maximum controllable water
and above and whose steam pressure can be up to more than 200kPa.
5.3.2.1.2 One sink with the depth of 1m. The dimensions of the bottom surface
shall be able to ensure that all the test specimens can lie flat.
5.3.2.2 Environmental conditions
At room temperature within the range of 5°C to 30°C.
5.3.2.3 Procedures
5.3.2.3.1 Repeatedly CONDUCT the test for 20 times according to the
sterilization or disinfection methods specified by the manufacturer.
5.3.2.3.2 SOAK in the sink with the depth of 1m for 12h.
5.3.2.3.3 TAKE out the endoscopes. CLEAN the surfaces according to the
routine method.
5.3.2.3.4 OBSERVE the optical system.
5.4 Strength and stiffness tests
5.4.1 Strength test
CONDUCT the maximum force or torque test according to the methods
indicated by the manufacturer. If the manufacturer indicates no methods,
SELECT the point of force application and the direction according to the worst
conditions.
5.4.2 Stiffness test
CONDUCT the maximum deflection and force tests according to the methods
indicated by the manufacturer. If the manufacturer indicates no methods,
APPLY force to the direction perpendicular to the initial mechanical axis at the
farthest end according to the way of cantilever beam, so as to conduct the
maximum deflection test.
5.5 Connection inspection
USE visual observation combined with the hand-feeling inspection for
verification.
5.6 External surface quality of the insertion portion
USE visual ...
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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