YY/T 0283-2007 PDF EnglishUS$160.00 · In stock · Download in 9 seconds
YY/T 0283-2007: Large intestine fiber endoscope Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Obsolete YY/T 0283: Historical versions
Similar standardsYY/T 0283-2007: Large intestine fiber endoscope---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0283-2007YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.70 C 40 Replacing YY/T 0283-1995 Large intestine fiber endoscope Issued by. China Food and Drug Administration Issued on. JULY 02, 2007 Implemented on. MARCH 01, 2008 Table of ContentsForeword... 3 1 Scope... 4 2 Normative references... 4 3 Classification... 5 4 Requirements... 5 5 Test methods... 8 6 Inspection rules... 14 7 Marking and operation instructions... 15 8 Package, transportation and storage... 16 Annex A... 18 Annex B... 25 Annex C... 26ForewordThis Standard is the revision of YY/T Q283-1995 “Large Intestine Fiber Endoscope”. Compared with YY/T 0283-1995, main differences in this Standard are as follows. — Specify the name of standard; — Add the classification of waterproof ability of product; — Increase the quantity index of broken-fiber number; — Add the coincidence requirements between illumination source and observation view-field; — Modify the requirements on product marking; — Add the requirements on waterproof product; — Add the requirements on biocompatibility; — Modify the test method of view-field angle; — Delete the requirements on sealing property in previous standard; — Add Annex A (Normative). For electrical connection part, it shall comply with GB 9706.1-1995 “Medical Electrical Equipment - Part 1.General Requirements for Safety”, GB 9706.4-1999 “Medical Electrical Equipment - Part 2.Particular Requirements for the Safety of High Frequency Surgical Equipment”, and GB 9706.19-2000 “Medical Electrical Equipment - Part 2.Particular Requirements for the Safety of Endoscopic Equipment”. The details are given in Annex A (Normative). Annex A and B of this Standard are normative; Annex C is informative. This Standard replaces YY/T 0283-1995, since the date of issuance. This Standard was approved by State Food and Drug Administration. This Standard shall be under jurisdiction of National Technical Committee on Medical Optical Instruments of Standardization Administration of China. Drafting organization of this Standard. Medical Optical Equipment Factory of Shanghai Medical Instruments Co., Ltd. Main drafters of this Standard. Li Yafen, Sun Qi, and Shen Tianming. This Standard was first-time published in November 1995. Large Intestine Fiber Endoscope1 ScopeThis Standard specifies the classification, marking, requirements, test methods, inspection rules, identification, operation instructions, packaging, transportation, and storage of large intestine fiber endoscope. This Standard is applicable to large intestine fiber endoscope (hereinafter referred as fiber endoscope). This product is used to the examination and diagnosis of large intestine cavity and can also be used in the relevant surgical operation.2 Normative referencesThe provisions in following documents become the provisions of this Standard through reference in this Standard. For dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this Standard, however, parties who reach an agreement based on this Standard are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies. GB/T 191-2008 Packaging - Pictorial marking for handling of goods GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability) GB 9706.1-1995 Medical electrical equipment - Part 1.General requirements for safety GB 9706.4-1999 Medical electrical equipment - Part 2.Particular requirements for the safety of high frequency surgical equipment GB 9706.19-2000 Medical electrical equipment - Part 2.Particular requirements for the safety of endoscopic equipment GB 11244-2005 General requirements for the medical endoscope and endoscope accessories GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1.Evaluation and testing3 Classification3.1 Fiber endoscope includes sigmoidoscope and colonoscope.4 Requirements4.1 Working conditions The normal working conditions of fiber endoscope. 4.2 Surface requirements 4.2.1 The coherence of each connecting part shall be reliable and fixed. The welding part shall be flat without fake welding, de-soldering or overlaying. 4.2.2 The external surface of head-end, bend part and inserted hose part shall be flat and smooth, without obvious bulge, scratch or burr. 4.3 Performance of optical system 4.3.1 Illumination shall not be less than 8 000 lx, at working distance. 4.3.2 Resolution ratio shall not be lower than 3.51 lp/mm, at working distance. 4.3.3 The quantity of the broken-fiber of coherent fiber bundle must not be more than 5 pieces, within 50% of view-field scope. The total quantity must not be more than 10 pieces. 4.4 Water supply and suction system 4.4.1 Supplied water can wash the surface of lens. The flow of supplied water shall not be lower than 45 mL/min. 4.5 Bend-angle operation system 4.5.1 Bend-angle locking structure shall be able to tightly lock the hand-wheel. The bend-angle part shall be able to do bend action under locking state. After locking is released, it shall not affect the operating function of bend-angle hand-wheel. There is no too-tight, too loose or stuck-up phenomenon during operation. 4.6 Sealing 4.6.1 Fiber endoscope shall be soaked in water as a whole. Its internal cavity can withstand pressure of 22 kPa for 3 min; without air leakage (applicable to waterproof type). 4.6.2 The head-end part shall be used within 20°C ~ 40°C. The surface of optical parts shall not generate mist due to temperature variation that affect observation. 4.7 Marking 4.7.1 The inserted flexible tube shall be marked with length marking. The marked line and words shall be legible. 4.9 Biocompatibility Fiber endoscope is a medical device which contacts with mucous membrane for short-term in accordance with GB 16886.1-2001.The surface of the part inserted into human body shall be made of materials which are proved to conform to biocompatibility or pass the following tests. 4.11 Requirements on ambient test Conform to atmosphere environmental test group II, mechanical environmental test group II and table 3 in GB/T 14710-1993. 4.12 Safety Fiber endoscope shall conform to the relevant requirements in GB 9706.1-1995, GB 9706.4-1999 and GB 9706.19-2000.For details, refer to annex A (Normative).5 Test methods5.1 Surface requirements Adopt visual inspection and hand-touch inspection to check the surface. It shall conform to Article 4.2. 5.2 Performance of optical system 5.2.1 Illumination test 5.2.1.1 Under the voltage of 220V, insert the illumination tester specified in Annex B (Normative) into the cold lighting surface (150W). Adjust the illumination value of cold light source to above 70 000 lx. 5.2.3 Broken-fiber test Place a white paper with two circles drawn on it on the working surface; light it uniformly; observe from lens. The quantity of broken-fibers, within 50% of view-field and out of 50% of view-field shall conform to Article 4.3.3. 5.2.4 View-field angle test 5.2.4.1 Measuring instruments 5.2.5 Coincidence of illumination source and observation view-field Visual inspection shall be conducted under the maximum illumination of the provided lamp in accordance with Article 4.3.5. 5.2.6 Clear observation range Fix the endoscope; adjust the distance between objective lens and the observed object. When it is at 5mm and 100mm positions, observe through the eyepiece of endoscope; it shall be able to clearly see 1.0mm-wide strip; it shall conform to Article 4.3.6. 5.3 Water supply and suction performance test 5.6 Marking Adopt visual inspection to check whether the operation conform to Article 4.7. 5.7 Dimensions Measured by general measuring tools, it shall conform to Article 4.8. 5.8 Biocompatibility test 5.8.1 Cytotoxicity shall be tested in accordance with the method specified in Chapter 8 of GB/T 16886.5-2003.Cytotoxicity shall conform to the requirements in Article 4.9.1. 5.10 Environmental test Environmental test shall be conducted in accordance with the relevant requirements in GB/T 14710-1993 and Article 4.11 of this Standard. 5.11 Safety test Safety test shall be conducted in accordance with the methods specified in GB 9706.1-1995, GB 9706.4-1999, and GB 9706.19-2000.It shall conform to the requirements in Article 4.12.6 Inspection rules6.1 Classification of inspection The inspections of fiber endoscope are divided into exit-factory inspection and type inspection. 6.2 Exit-factory inspection 6.2.1 Product can be delivered out of factory after being confirmed as qualified through exit-factory inspection. 6.3 Type inspection 6.3.1 In case of the following circumstances, type inspection shall be conducted. 6.4 Biocompatibility evaluation 6.4.1 In case of the following circumstances, biocompatibility evaluation shall be conducted. 6.4.2 When conducting biocompatibility evaluation, select the samples according to test needs. All of samples shall pass inspection.7 Marking and operation instructions7.1 Marking 7.1.1 Fiber endoscope shall have the following marks. 7.1.2 Product qualification certificate shall have the following marks. 7.1.3 Outer package shall have the following marks. 7.2 Operation instruction It shall conform to the requirements specified in No. 10 “Management Regulations on Manual, Labelling, and Packaging Logo of Medical Instruments” issued by China Food and Drug Administration, and the relevant requirements in GB 9706.1-1995 and GB 9706.19-2000.8 Package, transportation and storage8.1 Package 8.2 Transportation It shall conform to the relevant requirements in order contract. 8.3 Storage The packed fiber endoscope shall be stored in the well-ventilated indoor environment where is free of corrosive gas, with the relative humidity not exceeding 80%. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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