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YY/T 0940-2014 PDF in English


YY/T 0940-2014 (YY/T0940-2014, YYT 0940-2014, YYT0940-2014)
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Standards related to: YY/T 0940-2014

YY/T 0940-2014: PDF in English (YYT 0940-2014)

YY/T 0940-2014
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
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
GB/T 14233.2-2005 Test Methods for Infusion, Transfusion, Injection Equipment
for Medical Use - Part 2: Biological Test Methods
GB/T 16886 (all parts) Biological Evaluation of Medical Devices
YY/T 0149-2006 Medical Instruments of Stainless Steel - Test Methods of
Corrosion Resistance
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.
4.1.2 Biocompatibility
The materials in contact with patients shall be evaluated for biosafety in accordance
with the principles and requirements of GB/T 16886.1 to prove that they have good
biocompatibility.
Biological evaluation may consider the results of biological tests; thereof, the selection
of test items is carried out in accordance with the guidelines of GB/T 16886.1.
For materials that have been previously proven to be applicable, if it can be proven
that the subsequent manufacturing process is not sufficient to produce biosafety
hazards, the biological test may not be repeated.
NOTE 1: The materials of the device under design have a demonstrable history of use in
specific applications, or information about materials and/or devices may be obtained from other
sources; then it is believed that the materials have previously been proven applicable.
NOTE 2: If the metal material uses the medical metal material suitable for the application range
in the national or industry standards; the biological test may not be repeated.
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.
4.1.3.2 pH: Compared with the blank control solution of the same batch, the pH
difference shall be less than 2.0.
4.1.3.3 The total content of heavy metals that can be dissolved: The total content of
heavy metals that can be dissolved in the dissolution solution does not exceed
5.0μg/mL.
4.1.3.4 Potassium permanganate reducing substance: the difference in consumption
with an equal volume of the same batch of blank control solution shall be less than
2.0mL.
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.
After the test method according to 5.4.3, there shall be no distortion, cracking or other
permanent deformation.
4.4.4 Rotation performance (applicable to grasping forceps with rotation
function)
The rotation shall be smooth, and there should be no shaking that interferes with the
user's usage when the clamp rod rotates.
4.4.5 Locking-meshing force (applicable to grasping forceps with locking device)
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.
4.5.2 Corrosion resistance
Use martensitic and austenitic stainless-steel materials to be tested according to the
boiling water test method in YY/T 0149-2006, and it shall meet the requirements of
Class-b; other materials are conducted once in accordance with the most unfavorable
disinfection and sterilization methods specified by the manufacturer in the instruction
manual; and there shall be no corrosion.
4.5.3 Performance withstanding repeated operation
It can withstand repeated operations for 20 times without damage or breakage.
4.6 Sterilization requirements (applicable to disposable products)
4.6.1 The grasping forceps shall be sterile.
If the grasping forceps are high-frequency surgical instruments, they shall meet the
requirements of GB 9706.4 and GB 9706.19.
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.
5.1.2 Biocompatibility
All tests are given priority to the relevant standards of GB/T 16886 and are carried out
according to its methods.
5.1.3 test method of dissolved and precipitated products
Preparation of the test solution: prepare according to the method of item 6 in Table 1
of GB/T 14233.1-2008.
5.1.3.1 Appearance: it shall be carried out according to the method specified in 5.1 of
GB/T 14233.1-2008.
5.1.3.2 pH: it shall be carried out according to the method specified in 5.4.1 of GB/T
14233.1-2008.
5.1.3.3 Heavy metals: it shall be carried out according to the method specified in 5.6
of GB/T 14233.1-2008.
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
manufacturer shall specify the placement state of the device in the test.
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.
5.5.2 Corrosion resistance test
Use martensitic and austenitic stainless-teel materials to be tested according to the
boiling water test method in YY/T 0149-2006. The remaining materials shall be
sterilized once in accordance with the disinfection and sterilization methods specified
by the manufacturer in the instruction manual.
5.5.3 Performance test withstanding repeated operation
It shall imitate the actual operation.
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
......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.