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YY 0847-2011: Medical endoscopes - Endotherapy device - Stone retrieval forceps
YY 0847-2011
Medical endoscopes - Endotherapy device - Stone retrieval forceps
ICS 11.040.99
C40
People's Republic of China pharmaceutical industry standards
Medical endoscope endoscopic instruments stone basket
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some content of this document may involve patents, publication of this document
Institutions do not assume the responsibility to identify these patents.
This standard was proposed by the State Food and Drug Administration.
This standard by the national medical and optical instruments Standardization Technical Committee (SAC/TC103/SC1) centralized.
This standard was drafted. State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center, Zhejiang Medical Devices Unit
The inspection.
The main drafters. Zhang Qin Yuan, JIA Xiao Hang, Yan Qing, the He Tao, Qi Weiming.
Medical endoscope endoscopic instruments stone basket
1 Scope
This standard specifies the stone basket scope, terms and definitions, requirements, test methods.
This standard applies to endoscopic surgery can be used as a standalone product stone basket.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 1962.1-2001 6% for syringes, needles and other medical equipment (Luer) taper fittings - Part 1. General
Claim
GB/T 1962.2-2001 syringes, needles and other medical equipment - 6% (Luer) taper fittings - Part 2. Lock fittings
GB 4234-2003 stainless steel surgical implants
GB/T 14233.1-2008 Infusion, transfusion, injection equipment - Part 1. Chemical analysis
GB/T 14233.2-2005 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test
YY/T 0149-2006 stainless steel medical equipment corrosion test methods
YY 0294.1-2005 surgical instrument metallic materials - Part 1. Stainless steel
YY/T 1052-2004 mark surgical instruments
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Basket wirebasket
One kind of mesh baskets for taking lap stones, foreign objects or tissue samples.
3.2
Stone basket stoneretrievalforceps
One kind specified endoscope with endoscopic instruments used mainly by the handle, an elongated cable guide catheter and the tip of the composition of the basket, through
Over the basket trap live stones, foreign objects or tissue sample, then crawl through the basket strong contraction stones, foreign objects or tissue samples.
3.3
Inserting portion insertionportion
Part of the stone basket, which can be inserted into the body part natural orifice or a surgical incision, or insert an endoscope or endoscopic instrument channel device
Mechanical instrument channel.
3.4
Maximum insertion portion width maximuminsertionportionwidth
The maximum width of the outer portion of the insert.
3.5
Working length workinglength
Take the maximum length of the insertion portion of the stone basket.
3.6
Endoscopic instruments endotherapydevice
In endoscopic surgery, to check, diagnostic or therapeutic purposes, and the endoscope through the same or different channels to enter the body's natural hole
Tract or surgical incision medical devices.
Note 1. The number of an endoscopic instrument comprising an endoscopic instrument to guide the instrument inserted. Some endoscopic instruments are also included in the observation using the endoscope, for safety
Purposes different from the endoscope into the opening of the body of the instrument.
4 Requirements
4.1 with the contact material used in some patients
4.1.1 Chemical Composition Requirements
Contact with the material used in some patients, the manufacturer should be given explicit in any possible form, wherein the metal material shall be marked with grades and /
Or code and the chemical composition of the material requirements, the chemical composition of the metallic material should be verified by experiment.
4.1.2 biocompatibility
Materials and patient contact should be based on biological safety evaluation GB/T 16886.1 principles and requirements to demonstrate good
Biocompatibility.
Biological Evaluation of the results of biological tests considered, select pilot projects in accordance with GB/T 16886.1 of the guidelines. All test
Experience preferred GB/T 16886 of the relevant part.
For previously it has been proved to be suitable materials, if they can prove that the subsequent process of its manufacture is insufficient to produce bio-safety hazards, can no longer
Repeat biological experiments.
Note 1. Materials Design instrument has demonstrable history of use in specific applications, or can be obtained from other sources to related materials and/or information devices can be
That the material has previously been proved to be suitable.
Note 2. If the metal material by the state or industry standard application for medical metal materials, biological tests may not be repeated.
4.1.3 The precipitate was dissolved contact with the body portion of the polymeric material
4.1.3.1 Surface/Appearance. colorless, transparent, visual inspection with no foreign body.
4.1.3.2 pH. pH difference of 2.0 or less.
4.1.3.3 Heavy Metal. Dissolution was 5.0μg/mL or less.
4.1.3.4 Potassium permanganate reducing substances. the consumption of the standard test solution difference 2.0mL or less.
4.1.3.5 steaming residue. 2.0mg or less.
4.2 Appearance
4.2.1 In addition to the special purpose, the outer surface should not have any security may cause harm.
4.2.2 basket no random wire, loose or other obvious abnormalities, no damage.
4.2.3 basket shape illustrated herein should be identical.
4.2.4 Push the handle to open and close the basket, the connecting portion of the handle, the insertion portion and the basket does not come off or loose.
4.2.5 the insertion portion without damage.
4.3 Dimensions
4.3.1 The maximum width of insertion portion
Manufacturers in the specification should be given the maximum width of insertion portion of the nominal value.
Found not be greater than the nominal value.
4.3.2 Working length
Manufacturers should be given in the specification of the working length of the nominal value and gives a schematic view of the express.
Working length of the nominal value tolerance. ± 3%.
4.3.3 open width basket
Manufacturers should be given in the specification in the natural state of relaxation of the nominal value of the basket to open web and gives a schematic express.
The nominal value of the basket open width tolerance. -20%, the upper limit is not counted.
4.3.4 The effective length basket
Manufacturers in the specification should be given the effective length of the nominal value of the basket in the natural state of relaxation and gives a schematic express.
Basket effective length of the nominal value of tolerance. -20%, the upper limit is not counted.
4.4 Performance
4.4.1 Tensile strength.
Manufacturers in the accompanying information shall be given outside the maximum tension throughout the stone basket can bear, and tests proved stone at the Rally
Basket should not be damaged.
4.4.2 basket should open and close smoothly.
4.4.3 If the stone basket with rotation, the rotation should be smooth.
4.5 tolerance (non-disposable products applicable)
4.5.1 high temperature high pressure performance
Identified as autoclavable basket of stone, can not be broken after the high temperature high pressure test 20 times.
4.5.2 Corrosion Resistance
Stainless steel section Press YY/T 0149-2006 in boiling water test method to test, in line with b-level requirements; the rest of the material in accordance with
For the most unfavorable instrument sterilization methods specified by the manufacturer in the specification once, should have good corrosion resistance.
4.5.3 withstand repeated operation performance
Capable of withstanding repeated operation 20 times without breakage, fracture.
4.6 sterility requirements (for aseptic packaging products)
4.6.1 stone basket should be sterile.
4.6.2 residual ethylene oxide (for ethylene oxide sterilization).
Residual ethylene oxide concentration. 25μg/g or less.
4.7 luer connector (for stone basket having an injection port)
Shall comply with GB/T 1962.1-2001 and GB/T 1962.2-2001 relevant requirements.
4.8 Specification
4.8.1 should contain endoscopes and other medical devices with the stone basket used in conjunction with (eg. gravel filter) is clearly stated, so make
Wearer can follow this guide to select the appropriate endoscopes and other medical devices.
4.8.2 stone basket stone basket should include a schematic shape in a natural state of relaxation, stone basket should contain the names and functions of each part
The presentation, given schematic if necessary.
4.8.3 should contain product specifications.
4.8.4 should contain the description of the intended use of the product.
4.8.5 using the product should include preparation, examination and operating instructions.
4.8.6 should include environmental protection contents.
--- Specified for waste, residues, etc., and any risk management at the end of its useful life is;
--- Provide these recommendations to minimize the risk.
4.8.7 If the stone basket is not disposable products, the instructions shall include information on the available cleaning, disinfection or sterilization methods
Details, where appropriate, specify the appropriate disinfectants, and lists the components of these devices can withstand the temperature, pressure, humidity and time limits.
4.8.8 handling, transport and storage environment restrictions. the provisions should allow the ambient conditions operating, transportation and storage time.
4.9 tag label
The product should be clearly and easily recognizable and permanent firmly affixed in the form of marks, the name of the manufacturer or supplier and (or) trademark.
5 Test methods
5.1 Testing and Materials
5.1.1 Chemical composition test
Using the current approved methods of chemical analysis of metallic materials test results should meet the requirements of 4.1.1.
5.1.2 biocompatibility
Biological tests recommended GB 16886 related parts.
5.1.3 Test Method precipitate dissolved
5.1.3.1 Surface/Appearance. according to GB/T 14233.1-2008 Table 1, item 6 of the test solution was prepared, and then follow the GB/T 14233.1-
5.1 2008 will be specified.
5.1.3.2 pH. according to GB/T 14233.1-2008 Table 1, item 6 of the test solution was prepared, and then follow the GB/T 14233.1-
2008 will be the method specified in 5.4.1.
5.1.3.3 Heavy metals. according to GB/T 14233.1-2008 Table 1, item 6 of the test solution was prepared, and then follow the GB/T 14233.1-
2008 5.6 Method specified conduct.
5.1.3.4 Potassium permanganate reducing substances. According to GB/T 14233.1-2008 Table 1, item 6 of the test solution was prepared, and then follow
The method GB/T 14233.1-2008 be specified in 5.2.
5.1.3.5 evaporation residue. according to GB/T 14233.1-2008 Table 1, item 6 of the test solution was prepared, and then follow
The method GB/T 14233.1-2008 be specified in 5.5.
5.2 Appearance
5.2.1 touch, visual, should meet the requirements of 4.2.1.
5.2.2 touch, visual, should meet the requirements of 4.2.2.
5.2.3 visual comparison should meet the requirements of 4.2.3.
5.2.4 touch, visual, should meet the requirements of 4.2.3.
5.2.5 with fingertips stroked the entire surface of the insertion portion, should not crush, excessive bending and other damage.
5.3 Dimensions
5.3.1 test with a universal measuring tool should meet the requirements of 4.3.1.
5.3.2 test with a universal measuring tool should meet the requirements of 4.3.2.
5.3.3 distance between the point of tangency general gauge measuring the maximum cross section of the basket between, after averaging, as calculated by the geometric
In the cross-sectional diameter of the circle, as the amplitude of the opening should meet the requirements of 4.3.3.
5.3.4 test with a universal measuring tool should meet the requirements of 4.3.4.
5.4 Performance Test
5.4.1 tensile strength test
Said tension is applied to the maker of the entire stone basket, all parts of the stone basket shall not be damaged breakage.
5.4.2 the insertion portion coiled 10cm radius of the arc or circle, push and pull the handle, the basket should open and close smoothly.
5.4.3 the insertion portion coiled 10cm radius of the arc or circle, open basket, turn the handle, basket rotation should be smooth.
5.5 tolerance test
5.5.1 Performance test high temperature high pressure
High temperature high pressure test 20 times, you should still meet the requirements of 4.2, 4.4.
5.5.2 corrosion resistance test
Stainless steel section Press YY/T 0149-2006 test in boiling water test method should meet the requirements of 4.5.2. The remaining material
Expected to conduct a sterilization method in accordance with manufacturer's specified in the specification should be no corrosion.
5.5.3 withstand repeated operation performance test
Imitation actual operation, shall comply with the requirements of 4.5.3.
5.6 Sterility test
5.6.1 The method according to GB/T 14233.2-2005 be specified, should meet the requirements of 4.6.1.
5.6.2 according to GB/T 14233.1-2008 stipulated in gas chromatography, it should meet the requirements of 4.6.2.
5.7 luer test
According to GB/T 1962.1-2001 and GB/T 1962.2-2001 related trials should meet the requirements of 4.7.
Check the product manual 5.8
Check the contents of the product manual provided by the manufacturer, should meet the requirements of 4.8.
5.9 tag label inspection
By visual inspection mark on the product label content should meet the requirements of 4.9.