YY/T 0940-2014 PDF English
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| YY/T 0940-2014 | English | 170 |
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Medical Endoscopes - Endotherapy Device - Grasping Forceps
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YY/T 0940-2014: Medical Endoscopes - Endotherapy Device - Grasping Forceps---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/YYT0940-2014
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THEPEOPLE’S REPUBLIC OF CHINA
ICS 11.040.99
C 40
Medical Endoscopes - Endotherapy Device - Grasping
Forceps
Issued on. JUNE 17, 2014
Implemented on. JULY 01, 2015
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative References... 4
3 Terms and Definitions... 5
4 Requirements... 5
5 Test Methods... 10
6 Inspection Rules... 14
Foreword
This Standard was drafted as per the rules specified in GB/T 1.1-2009.
Please note some contents of this document may involve the patents. The issuing
agency of this document shall not assume the responsibility to identify these patents.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Subcommittee for
Standardization of Medical Optics and Instruments (SAC/TC 103/SC 1).
Drafting organizations of this Standard. Zhejiang Institute for the Control of Medical
Device; and Medical Device Supervising and Testing Center of Hangzhou, State Food
and Drug Administration.
Chief drafting staffs of this Standard. Qi Weiming, Zhang Qinyuan, Jia Xiaohang, and
Yan Qinglai.
Medical Endoscopes - Endotherapy Device - Grasping
Forceps
1 Scope
This Standard specifies the scope, terms and definitions, requirements, and test
methods of grasping forceps.
This Standard is applicable to grasping forceps used in endoscopic surgery.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) is applicable to this document.
GB/T 1962 (all parts) Conical Fittings with a 6% (Luer) Taper for Syringes,
Needles and Certain other Medical Equipment
GB/T 4340.1-2009 Metallic Materials - Vickers Hardness Test - Part 1.Test
Method
GB 9706.4 Medical Electrical Equipment - Part 2-2.Particular Requirements for
the Safety of High Frequency Surgical Equipment
GB 9706.19 Medical Electrical Equipment - Part 2.Particular Requirements for
the Safety of Endoscopic Equipment
GB/T 14233.1-2008 Test Methods for Infusion Transfusion Injection Equipment
for Medical Use - Part 1.Chemical Analysis Methods
3 Terms and Definitions
For the purpose of this document, the following terms and definitions apply.
3.1 Grasping forceps
An endotherapy device that is used in conjunction with a designated endoscope, which
is mainly composed of a handle, a clamp rod, and a clamp head; and is used to grasp
and obtain human tissue.
3.3 Maximum insertion portion width
The maximum outer width of the insertion portion
3.4 Working length
The maximum length of the insertion portion of the grasping forceps.
3.5 Endotherapy device
In endoscopic surgery, for the purposes of inspection, diagnosis or treatment, it is a
medical device that enters the human body's natural orifice or surgical incision through
the same or different channel as the endoscope.
4 Requirements
4.1 Materials used in contact with the patient
4.1.1 Requirements for chemical composition
The part of material that is used in contact with the patient shall be clearly stated by
the manufacturer in any possible form. Among them, the metal material shall be
marked with the designation and/or code and the chemical composition requirements
of the material; and the chemical composition of the metal material shall be verified
through tests.
4.1.3 Dissolved and precipitated products of polymer materials in contact with patients
4.1.3.1 Appearance (turbidity, color). colorless and transparent; no foreign matter can
be seen by visual inspection.
4.1.3.5 Evaporation residue. The total dry residue of the dissolution solution shall be
less than 2.0mg.
4.1.4 Hardness
The clamp head shall meet the hardness requirements specified by the manufacturer.
4.1.5 The manufacturer shall claim that the surface part of the device that uses metal
materials shall be consistent with the internal material. If it is really necessary to coat
the surface of the device, the manufacturer shall provide the corresponding coating
requirements and test methods.
4.2 Appearance
4.2.1 Under the field of view of the endoscope, the visible tip of the surgical instrument
shall be processed to eliminate possible directional reflection.
4.2.2 Except for special purposes, there shall be no possible damage such as burrs
on the outer surface.
4.3 Dimensions
4.3.1 Maximum insertion portion width
The manufacturer shall give the nominal value of the maximum insertion portion width
in the instruction manual.
4.4 Use performance
4.4.1 Opening and closing performance
The opening and closing of the clamp head shall be smooth, and the clamp rod shall
not be shaken that interferes with the user's usage when opening and closing.
4.4.2 Clamping force
There shall be a certain clamping force.
The manufacturer shall give the meshing force of the clamp head in the locking state;
and its actual meshing force shall not exceed 20% of the manufacturer's stated value.
4.4.6 Closing force transmission coefficient
The force transmission coefficient between the force applied by the handle and the
closing force of the clamp head shall comply with the manufacturer's provisions.
4.4.7 Tooth shape of the clamp head
The arrangement of the tooth shape of the grasping forceps head shall meet the design
requirements, and the tooth shape shall be clear, accurate, and in place.
4.5 Tolerance (applicable to non-disposable products)
4.5.1 High-temperature and high-pressure resistance
The grasping forceps marked as being able to withstand high-temperature and high-
pressure shall still meet the requirements of 4.4 after 20 high-temperature and high-
pressure tests.
4.6 Sterilization requirements (applicable to disposable products)
4.6.1 The grasping forceps shall be sterile.
4.6.2 Residual ethylene oxide (applicable to products using ethylene oxide sterilization
method), and residual concentration of ethylene oxide. 10μg/g below.
4.7 Luer connector (applicable to the grasping forceps with the filling port)
It shall meet the relevant requirements of GB/T 1962 (all parts).
4.8 Product instruction manual
4.8.1 It should contain a clear description of the endoscope and its accessories that
can be used in conjunction with the grasping forceps; so that the user can select the
appropriate endoscope and its accessories according to this guide.
4.8.8 Operation, transportation and storage environmental restrictions. the allowable
environmental conditions for operation, transportation and storage shall be specified.
4.9 Marking and labels
The product shall have a clearly identifiable and permanently affixed marks, the name
and/or trademark of the manufacturer or supplier.
4.11 Water/air flow performance (applicable to grasping forceps with filling ports)
The manufacturer shall give requirements and test methods for the water or air flow of
the injection channel.
5 Test Methods
5.1 Material test
5.1.1 Chemical composition test
The chemical composition analysis test of metal materials is carried out with the
method whose accuracy reaches or is better than 1/3 of the tolerance or limit.
5.1.3.4 Potassium permanganate reducing substances. it shall be carried out
according to the method specified in 5.2 of GB/T 14233.1-2008.
5.1.3.5 Steaming residues. it shall be carried out according to the method specified in
5.5 of GB/T 14233.1-2008.
5.1.4 Hardness test
It shall be carried out according to the method specified in GB/T 4340.1-2009; measure
3 points on each of the 2 pieces of clamp head; and take the arithmetic average of
every 3 points.
5.2 Appearance
5.2.1 Imitate actual operation and take visual inspection.
5.2.2 Defects such as burrs. feel it, and take visual inspection.
5.3 Dimensions
5.3.1 Inspection of the maximum insertion portion width
Use universal measuring tools to test.
5.4 Use performance test
5.4.1 Opening and closing test
Imitate actual operation and take visual inspection.
5.4.2 Clamping force test
Clamp a No. 7 type-Ⅰ suture thread specified by YY 0167-2005 at the front 1/3 of the
head of the grasping forceps; the grasping forceps are completely closed; and apply
the manufacturer's specified pulling force to the suture thread in a direction parallel to
the main axis of the clamp rod. The suture thread must not slip off.
5.4.5 Locking-meshing force
The locking-meshing force is tested in a simulated application state. The slightly open
state of the clamp head is given by the manufacturer; and is expressed by the open
height at the 1/3 front of the head. Put the handle of the grasping forceps in the locking
state; and measure the meshing force value at the1/3 front of the head in this state,
which is the locking-meshing force.
5.4.6 Closing force transmission coefficient
The test is performed in a simulated application state. The slightly open state of the
clamp head is given by the manufacturer. It is expressed by the open height at the 1/3
front of the head. The force fi on the handle is within the range of 5N~20N; and the
sampling interval is no greater than 3N. Record the closing force value fo perpendicular
to the bisector of the opening angle of the clamp head at the 1/3 front of the head; and
fit the collected data through the least squares method to get the value of fo/fi, which is
the closing force transmission coefficient.
5.4.7 Tooth type test of clamp head
Use a 10x magnifier to observe the alignment.
5.5 Tolerance test
5.5.1 High-temperature and high-pressure resistance test
After repeating the test for 20 times in accordance with the manufacturer's high-
temperature and high-pressure test method, the test shall be carried out according to
the method of 5.4.
5.6 Sterilization requirement test
5.6.1 It shall be carried out according to the method specified in GB/T 14233.2; thereof,
the preparation method of the test solution can be specified by the manufacturer, if it
is not applicable.
5.6.2 It shall be carried out in accordance with the gas chromatography method
specified in Clause 9 of GB/T 14233.1-2008.
5.7 Luer connector test
It shall be carried out according to related tests of GB/T 1962.
5.8 Inspection of product instruction manual
Check the contents of the product instruction manual provided by the manufacturer.
5.9 Inspection of marking and label
Visually inspect the contents of the marking and label on the product.
5.10 Electrical safety test methods
It shall be carried out according to the method in GB 9706.4 and GB 9706.19.
5.11 Water/air flow performance
It shall be carried out according to the test method specified by the manufacturer.
6 Inspection Rules
The inspection rules are determined by the manufacturer according to the product
characteristics.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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