YY/T 0943-2014 English PDF (YYT0943-2014)

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YY/T 0943-2014: Medical endoscopes. Endotherapy device. Needle forceps
YY/T 0943-2014
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.99
C 40
Medical endoscopes - Endotherapy device - Needle 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 ... 4
4 Requirements ... 5
5 Test methods ... 9
6 Inspection rules ... 13
Medical endoscopes - Endotherapy device - Needle forceps
1 Scope
This Standard specifies the scope, terms and definitions, requirements, test methods for
needle forceps.
This Standard applies to needle forceps used in endoscopic surgery.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
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/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 0043-2005, Medical suture needle
YY/T 0149-2006, Medical instruments of stainless steel - Test methods of corrosion
resistance
YY 0167-2005, Non-absorbable surgical suture
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 needle forceps
An endoscopic instrument for use with a designated endoscope. It is mainly composed
of handle, forceps rod, forceps head. It is used to hold suture needles.
may not be repeated.
NOTE 1: When the material of the device in the design has a demonstrable history of use in a
specific application, or information about the material and/or the device can be obtained from other
sources, it can be considered that the material has been previously demonstrated to be suitable.
NOTE 2: If the metal material adopts 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 Dissolution extracts of polymeric materials in patient contact parts
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 Total content of soluble heavy metals: The total content of soluble heavy metals
in the dissolution solution does not exceed 5.0μg/mL.
4.1.3.4 Potassium permanganate reducing substance: The consumption difference with
the same volume of blank control solution in the same batch 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 forceps head shall meet the hardness requirements specified by the manufacturer.
4.1.5 Surface and internal material consistency
The manufacturer shall claim that the surface of the part of the device made of metal
material is consistent with the internal material. If it is really necessary to coat the
surface of the device, the manufacturer shall give the corresponding coating
requirements and test methods.
4.2 Appearance
4.2.1 Under the endoscopic field of view, the visible tip portion of the surgical
instrument shall be treated, so as to eliminate possible directional reflections.
4.2.2 Except for special purposes, the outer surface shall not have burrs and other
defects that may cause injury.
4.2.3 The locking teeth on the locking mechanism of the needle forceps shall be
complete.
4.3 Size
4.3.1 Maximum insertion portion width
The manufacturer shall give the nominal value of the maximum insertion portion width
in the instructions for use.
The measured value shall not be greater than the nominal value.
4.3.2 Working length
The manufacturer shall give the nominal value of the working length in the instructions
for use and give a schematic illustration.
The tolerance of nominal value of working length: ±3%.
4.3.3 Maximum opening range of forceps head
The manufacturer shall give the nominal value of the maximum opening range of the
forceps head in the instructions for use and give a schematic diagram to show it clearly.
The tolerance of nominal value of opening range of the forceps head: ±20%.
4.4 Use performance
4.4.1 Opening-closing performance
The forceps heads shall open and close smoothly. When the forceps rods are opened
and closed, there shall be no shaking that interferes with the user's use.
4.4.2 Clamping force
There shall be a certain clamping force.
4.4.3 Locking performance
The use of the lock shall be flexible and reliable. It shall not be able to bounce off when
it is unintentional in the locked state. When the locking teeth are fully locked, the tooth
surface of the front 3/5 of the lip teeth shall all contact the forceps head. The tooth
profile of the two tooth surfaces shall be completely close.
4.4.4 Elasticity and firmness
After the test method in 5.4.4, there shall be no distortion, cracking or other permanent
deformation.
4.4.5 Rotation performance (for needle forceps with rotation function)
Rotation shall be smooth. When the forceps rods are rotated, there must be no shaking
that interferes with the user's use.
diagram if necessary.
4.8.3 Product specifications shall be included.
4.8.4 A statement of the intended use of the product shall be included.
4.8.5 Instructions for preparation, inspection and operation when using the product shall
be included.
4.8.6 It shall include environmental protection information:
- Specify any risks regarding waste, residues and their disposal at the end of their
service life;
- Provide advice on minimizing these risks.
4.8.7 If the needle forceps are not single-use products, the instructions for use shall
include details on the methods of cleaning, disinfection or sterilization that can be used.
Prescribe suitable disinfectants when necessary. List the temperature, pressure,
humidity, and time limits to which these equipment components can withstand.
4.8.8 Operation, transportation and storage environmental restrictions: The allowable
environmental conditions for operation, transportation and storage shall be specified.
4.9 Labelling
There shall be clearly legible and permanently affixed formal marks, the name and/or
trademark of the manufacturer or supplier on the product.
NOTE: If it is a single-use product, it can be marked on sterile packaging.
4.10 Water/ventilation performance (for needle forceps with injection ports)
The manufacturer shall give requirements and test methods for the water or ventilation
volume 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 shall be carried out by a
method whose accuracy is equal to or better than 1/3 of the tolerance or limit value.
5.1.2 Biocompatibility
All tests are preferably carried out accordin...