YY/T 0283-2007Large intestine fiber endoscope (English PDF)

4.1 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).

5.1 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.

6.1 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.

7.1 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.

8.1 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%. […]