YY 0847-2011 (YY0847-2011) & related versions
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Medical endoscopes - Endotherapy device - Stone retrieval forceps
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YY 0847-2011: PDF in English
YY 0847-2011
YY
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.99
C 40
Medical endoscopes - Endotherapy device –
Stone retrieval forceps
ISSUED ON. DECEMBER 31, 2011
IMPLEMENTED ON. JUNE 1, 2013
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 ... 9
6 Inspection rules ... 12
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some content of this document may involve patents. The
issuing agency of this document does not undertake the responsibility for the
identification of these patents.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of National Medical Optical
Instrument Standardization Technical Committee (SAC/TC103/SC1).
The drafting organizations of this Standard. Supervising and Testing Center of
Hangzhou Zhejiang Institute of State Food and Drug Administration, and
Zhejiang Institute for the Control of Medical Device.
Main drafters of this Standard. Zhang Qinyuan, Jia Xiaohang, Yan Qinglai, He
Tao and Qi Weiming.
Medical endoscopes - Endotherapy device –
Stone retrieval forceps
1 Scope
This Standard specifies the scope, terms and definitions, requirements and test
methods of stone retrieval forceps.
This Standard is applicable to stone retrieval forceps that is used for endoscopic
surgery as an independent product.
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 1962.1-2001 Conical fittings with a 6% (Luer) taper for syringes,
needles and certain other medical equipment - Part 1. General requirement
GB/T 1962.2-2001 Conical fittings with a 6% (Luer) taper for syringes,
needles and certain other medical equipment - Part 2. Lock fittings
GB 4234-2003 Stainless steel for surgical implants
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
YY 0294.1-2005 Surgical instruments - Metallic materials - Part 1. Stainless
steel
YY/T 1052-2004 Marking requirements for surgical instruments
3 Terms and definitions
The following terms and definitions are applicable to this document.
3.1 Wire basket
A mesh basket that is used for taking stone, foreign matter or tissue sample.
3.2 Stone retrieval forceps
An endotherapy device that works with designated endoscope, which is mainly
composed of handle, slender guiding-rope and guiding-duct, and wire basket
on the head. It traps the stone, foreign matter or tissue sample via wire basket’s
circle; and firmly catches the stone, foreign matter or tissue sample through
contraction of wire basket.
3.3 Insertion portion
A part of stone retrieval forceps which can be inserted into human nature orifice,
surgical incision, endoscope’s device channel or endotherapy device’s channel.
3.4 Maximum insertion portion width
The maximum external width of insertion portion.
3.5 Working length
The maximum length of insertion portion of stone retrieval forceps.
3.6 Endotherapy device
A medical device, which is used in endoscopic surgery, goes into human nature
orifice or surgical incision through the same or different channel with endoscope,
so as to realize examination, diagnosis or treatment.
Note 1. Endotherapy device includes some devices that lead the endotherapy device to insert.
It also includes some devices that are used under observation of endoscope and go from
human opening which is different from the endoscope, for safety purpose.
4 Requirements
4.1 Material used in the part of contacting with patients
4.1.1 Requirements for chemical composition
Material used in the part of contacting with patients shall be clearly indicated in
any possible form by the manufacturer. Metal material shall be marked with
trademark and/or code as well as the material’s chemical composition
requirements. Metal material’s chemical composition shall be verified by
experiment.
4.1.2 Biocompatibility
For material used in the part of contacting with patients, it shall conduct
biological safety evaluation according to principles and requirements in GB/T
16886.1, so as to prove that it has good biocompatibility.
Biological evaluation shall consider the results of biological test. The selection
of test items are conducted according to the guideline of GB/T 16886.1.
Relevant parts of GB/T 16886 are preferred for all the tests.
For material that has previously been proved as applicable, if it can prove that
the following manufacturing process is insufficient to produce any biological
safety hazards, then it may be exempted from repeated biological test.
Note 1. When device’s material in design has demonstrable history of using in specific
application OR any obtainable material’s and/or device’s information from other aspects, it shall
be regarded that the material has been proved as applicable.
Note 2. If metal material uses medical metal material that is suitable in application scope of
national or industrial standard, it may be exempted from repeated biological test.
4.1.3 Polymeric material’s dissolving precipitates in the part of contacting
with patients
4.1.3.1 Surface / appearance. colorless and transparent, no foreign matter
inspected by visual inspection.
4.1.3.2 pH. pH difference is less than 2.0.
4.1.3.3 Heavy metal. leachables are less than 5.0 µg/mL.
4.1.3.4 Potassium permanganate reducing substances. consumption
difference with standard test solution is less than 2.0 mL.
4.1.3.5 Evaporation residue. less than 2.0 mg.
4.2 Appearance
4.2.1 Except for special purpose, there shall not have any possible safety-harm
on the outer surface.
4.2.2 There is no floss, loosing, other obvious abnormalities or damage for wire
5.3.4 Use a universal measuring tool to measure, according to requirements in
4.3.4.
5.4 Performance tests
5.4.1 Tensile strength test
Apply the nominal tension, provided by the manufacturer, to the whole stone
retrieval forceps. No damage or fracture on each part of stone retrieval forceps.
5.4.2 Coil the insertion portion into a circle or arc of which the radius is 10 cm;
push the handle; the stone retrieval forceps shall be open and close smoothly.
5.4.3 Coil the insertion portion into a circle or arc of which the radius is 10 cm;
open the stone retrieval forceps; turn the handle; the stone retrieval forceps
shall rotate smoothly.
5.5 Tolerance tests
5.5.1 High temperature and high pressure resistance test
After 20 tests of high temperature and high pressure resistance, it shall still
comply with requirements in 4.2 and 4.4.
5.5.2 Corrosion resistance test
Conduct boiling water test in YY/T 0149-2006 for the portion that uses stainless
steel, according to requirements in 4.5.2. For other materials, it shall conduct
once according to the sterilization method, as designated in the instructions for
use by the manufacturer. There shall have no corrosion.
5.5.3 Repeated operation resistance
For operation of actual-practice simulation, it shall comply with requirements in
4.5.3.
5.6 Sterility requirement test
5.6.1 Conduct in the method specified in GB/T 14233.2-2005, according to
requirements in 4.6.1.
5.6.2 Conduct in gas chromatography specified in GB/T 14233.1-2008,
according to requirements in 4.6.2.
5.7 Luer fitting test
Conduct according to relevant tests in GB/T 1962.1-2001, GB/T 1962.2-2001,
and requirements in 4.7.
......
| Standard ID | YY 0847-2011 (YY0847-2011) | | Description (Translated English) | Medical endoscopes - Endotherapy device - Stone retrieval forceps | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.99 | | Word Count Estimation | 9,933 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | GB/T 1962.1-2001; GB/T 1962.2-2001; GB 4234-2003; GB/T 14233.1-2008; GB/T 14233.2-2005; GB/T5 16886.1; YY/T 0149-2006; YY 0294.1-2005; YY/T 1052-2004 | | Drafting Organization | Hangzhou, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | | Administrative Organization | National Standardization Technical Committee of Medical optics and instruments | | Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard specifies the range of stone extraction baskets, terms and definitions, requirements, test methods. This standard applies to endoscopic surgery can be used as stand-alone products, stone basket. |
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