YY/T 0619-2017 English PDF (YYT0619-2017)

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YY/T 0619-2017: Medical Endoscopes - Rigid Resectoscope
YY/T 0619-2017
Medical endoscopes-Rigid resectosocope
ICS 11.040.99
C40
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0619-2007
Medical endoscope rigid electrocoagulation endoscope
Published on.2017-02-28
2018-01-01 implementation
State Food and Drug Administration issued
Content
Foreword I
1 range 1
2 Normative references 1
3 Classification and composition 1
4 Requirements 1
5 Test method 4
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0619-2007 "hard coagulation cutting endoscope", compared with YY 0619-2007 except editorial modification
The technical changes are as follows.
--- Added requirements for labels and accompanying materials (see 4.4);
--- Increased requirements for surface materials, materials, and dissolved precipitates of polymer materials used in contact with patients
(see 4.5.1, 4.5.2, 4.5.4);
--- Increased corrosion resistance requirements (see 4.6);
--- Increased requirements for disinfection and sterilization (see 4.7);
--- Increased packaging requirements (see 4.8);
---Modified the product composition and removed the guide beam in the composition (see 3.2,.2007 edition 4.2);
--- Revised the surface quality requirements of the components of the resectoscope (see 4.2.1, 4.2.2.6,.2007 edition 5.2);
--- Revised the basic size requirements of the resectoscope (see 4.2.1, 4.2.2.1, 4.2.2.2,.2007 edition 5.3);
---Modified the field of view quality of the resectoscope, eyepiece cover, fog layer, sealing, illumination spot, pressure steam sterilization requirements (see 4.1,
4.2.1.1,.2007 edition 5.5);
--- Revised the mechanical performance requirements of the electric mirror (see 4.2.1.1, 4.2.2.3, 4.2.2.7,.2007 version 5.6);
--- Revised the perfusion requirements of the resectoscope (see 4.2.2.4,.2007 edition 5.7);
--- Revised the biocompatibility requirements of the resectoscope (see 4.5.3,.2007 version 5.12);
--- Revised the electrical safety requirements of the resectoscope (see 4.9,.2007 version 5.13);
---Modified the basic parameters of the optical performance of the optical mirror in the electric mirror (see 4.1,.2007 edition 5.4);
--- Removed the illuminance uniformity requirement of the resectoscope (see.2007 edition 5.9);
--- Removed the plating requirements of the resectoscope (see.2007 edition 5.11);
--- Removed the environmental test requirements for the resectoscope (see.2007 version 5.14).
Please note that some of the contents of this document may involve patents. The publisher of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Optics and Instruments (SAC/TC103/SC1).
This standard was drafted. Zhejiang Medical Device Inspection Institute, Hangzhou Haoke Photoelectric Instrument Co., Ltd., Shenyang Shenda Endoscope Co., Ltd.
The main drafters of this standard. Zhang Yiyuan, Jia Xiaohang, Yan Qinglai, He Tao, Zhang Yuxing, Gao Lun, Chen Chong.
The previous versions of YY 0619 were released as follows.
---YY 0619-2007.
Medical endoscope rigid electrocoagulation endoscope
1 Scope
This standard specifies the classification, composition, requirements and test methods of rigid electrocoagulation electric resection endoscopes.
This standard applies to rigid electrocoagulation endoscopes (hereinafter referred to as resectoscopes). The electric resectoscope is clinically suitable for use under direct endoscopy.
High-frequency current thermal effect, cutting, vaporization and coagulation surgery on the diseased tissue.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 9706.4 Medical electrical equipment - Part 2-2. Particular requirements for safety of high-frequency surgical equipment
GB 9706.19 Medical electrical equipment - Part 2. Particular requirements for safety of endoscopes
GB/T 14233.1-2008 Medical infusions, blood transfusions, injecting machines - Test methods - Part 1
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
Medical endoscopes - Endoscopes - Part 1 . Optical performance and test methods
Medical endoscopes - Endoscopes - Part 2. Mechanical properties and test methods
YY 0068.3-2008 Endoscopes for medical endoscopes - Part 3. Labels and accompanying materials
Medical endoscopes - Endoscopes - Part 4. Basic requirements
YY/T 0149-2006 Test method for corrosion resistance of stainless steel medical instruments
YY/T 0842-2011 Medical endoscope endoscope attachment sheath
3 Classification and composition
3.1 Classification
3.1.1 According to the classification of GB/T 16886.1, the electric resectoscope is a medical device with short-term surface contact with mucous membrane.
3.1.2 According to the structure, it is divided into single sheath and double sheath.
3.1.3 According to the working mode of the operator, it is divided into active and passive.
3.1.4 Divided into single pole and bipolar according to the working mode of the electrode.
3.2 Composition
The resectoscope consists of an optical mirror, a sheath, a obturator, an operator, a surgical electrode, and a high frequency connection.
4 requirements
4.1 Optical performance of the endoscope
Should meet the requirements of YY 0068.1-2008.
4.2 Mechanical properties
4.2.1 General mechanical properties of the endoscope
4.2.1.1 The general mechanical performance requirements of the endoscope shall comply with the requirements of YY 0068.2-2008.
4.2.1.2 The general mechanical performance requirements of the sheath shall comply with the requirements of 4.2, 4.3, 4.4, 4.5 and 4.6 of YY/T 0842-2011.
4.2.2 Other mechanical properties
4.2.2.1 Surgical electrode size
4.2.2.1.1 Working electrode working length
The manufacturer shall give the nominal value of the working length in the accompanying materials and give a schematic illustration.
The deviation of the working length from the nominal value shall be within the tolerance specified by the manufacturer.
4.2.2.1.2 Maximum width of surgical electrode insertion part
The manufacturer shall give the nominal value of the maximum width of the inserted part in the accompanying documentation.
The measured value shall not be greater than the nominal value.
4.2.2.1.3 Surgical electrode travel
The nominal value of the surgical electrode stroke tolerance. ± 2mm.
4.2.2.2 High frequency cable size
The high frequency connection line length is >1500mm.
4.2.2.3 Connection reliability
The high-frequency cable plug and the surgical electrode should be connected reliably. When the moving part slides, it should not be loose or fall off.
4.2.2.4 Perfusion flow
The resectoscope should have a perfusion structure, and the flow rate during perfusion should be no less than 300mL/min.
4.2.2.5 Sealing performance
The sheath of the resectoscope and the operator, the endoscope and the operator and the water valve should be well sealed, and the leakage should not exceed 5 per 1 min.
Drip, the connection between the surgical electrode and the operator should not leak more than 5 drops per 10s.
4.2.2.6 Surgical electrode insertion part outer surface quality
4.2.2.6.1 The insertion part shall not have any safety hazard that may be caused except for special purposes.
For the insertion of the part that may cause safety damage for special purposes, all possible means should be used to avoid the undesired danger
The damage is minimized. At least the following instructions should be included in the accompanying materials.
a) warning of possible hazard indications, means of prevention of hazards, and handling instructions after the hazard is discovered;
b) safe operating procedures;
c) A statement that the operator is required to use specialized training.
4.2.2.6.2 In the field of view of the endoscope, the visible head end portion of the surgical electrode shall have no effect on the use of directional reflection.
4.2.2.7 Visibility of the surgical electrode
When the surgical electrode is moved to the distal position with the moving portion of the operator, its head end should be within the range observable by the endoscope.
4.3 Conduction performance
The high-frequency connection line of the resectoscope and the surgical electrode should be well-conducted, and the impedance value should be less than 3Ω.
4.4 Labels and accompanying materials
4.4.1 General requirements for labels and accompanying materials
Should meet the requirements of YY 0068.3-2009.
4.4.2 Labels and accompanying materials Other requirements
The manufacturer should indicate in the instruction manual the possibility of heat and other risks to the patient and operator when using the product.
a) thermal damage to the endoscope due to electrical or capacitive coupling of high frequency currents;
b) image interference on the video screen caused by high frequency electromagnetic waves;
c) keep the working part of the charged electrode within the operator's observation range to avoid accidental high frequency burns;
d) In order to ensure that the charged electrode is in the correct position during the operation, there must be sufficient distance from the end of the endoscope, at high frequency output
Avoid contact with metal parts and other conductors of the endoscope, including liquid vents that may be conductors, prior to excitation;
e) During the operation, the insulated high-frequency secondary accessories may be exposed to the protection of the charged electrodes;
f) to avoid high-frequency burns of the contralateral tissue, during the excitation of the charged electrode, its high-frequency current only acts on the clinically expected area of action;
g) Set the appropriate high frequency output power for the intended surgery to avoid unintended damage due to unreasonable settings.
4.5 Materials used in contact with the patient
4.5.1 Surface material
If the material used in contact with the patient is a metallic material, the exposed portion should be consistent with the internal material, if it is necessary to
For coating, the manufacturer shall give the corresponding coating requirements and test methods.
For the part of the insulating material on the product, do not use non-conductive coatings (such as paint) that do not provide long-lasting isolation. See the tolerance test.
4.7.1.
4.5.2 Material Requirements
The material used in the part in contact with the patient shall be clearly indicated in any form possible, and the metal material shall be marked with the grade and /
Or the code number and the chemical composition requirements of the material.
The polymer material should be given the Chinese and English name, the main structure and/or the CAS number.
The chemical composition of the metal material should be verified by experimentation.
4.5.3 Biocompatibility
Materials in contact with patients should be evaluated for biosafety in accordance with the principles and requirements of GB/T 16886.1 to demonstrate good
Biocompatibility.
The biological evaluation can consider the results of biological tests, and the selection of the test items is carried out according to the guidelines of GB/T 16886.1.
For materials that have previously been proven to be applicable, if it can be demonstrated that the subsequent process of manufacture is not sufficient to create a biosafety hazard,
Repeat the biological test.
Note 1. The material of the device under design has an arguable history of use in a specific application, or information about the material and/or device may be obtained from other aspects.
The material has been previously proven to be suitable for use.
Note 2. If metal materials are used in medical metal materials suitable for the application range of national or industry standards, biological tests may not be repeated.
4.5.4 Dissolved precipitates of polymer materials in contact with the patient
4.5.4.1 pH. Compared with the same batch of blank control solution, the pH difference should be no more than 2.0.
4.5.4.2 Total content of soluble heavy metals. The total content of soluble heavy metals in the eluate does not exceed 5.0 μg/mL.
4.5.4.3 Potassium permanganate reducing substance. the difference between the consumption of the same batch of blank control solution should be no more than 2.0mL.
4.6 Corrosion resistance (for non-disposable products)
The martensitic and austenitic stainless steel materials are tested according to the boiling water test method in YY/T 0149-2006, which is in accordance with class b.
Requirements; the remaining materials are in accordance with the most unfavorable disinfection and sterilization method specified by the manufacturer in the specification, meeting the requirements of Class B.
4.7 Disinfection and sterilization
4.7.1 Tolerability of re-sterilizable or sterilized products
Should meet the requirements of YY 0068.4-2009.
4.7.2 Aseptic supply products
Should meet the requirements of YY 0068.4-2009.
4.8 Packaging
Should meet the requirements of YY 0068.4-2009.
4.9 Electrical safety performance
4.9.1 The electrical safety performance requirements of the endoscope shall comply with the requirements of YY 0068.4-2009.
4.9.2 The electrical safety performance requirements of the surgical electrode should meet the requirements of GB 9706.4.
4.9.3 The electrical safety performance requirements for the interconnection conditions of the endoscope and the surgical electrode shall comply with the requirements of GB 9706.19.
5 Test methods
5.1 Optical performance test of endoscope
Test according to the method specified in YY 0068.1-2008, and verify the conformity of 4.1.
5.2 Mechanical performance test
5.2.1 Endoscope general mechanical performance test
5.2.1.1 Test according to the method specified in YY 0068.2-2008 and verify the conformity required by 4.2.1.1.
5.2.1.2 Test according to the methods specified in 5.2, 5.3, 5.4, 5.5...