YY/T 0283-2007 English PDF (YYT0283-2007)
YY/T 0283-2007 English PDF (YYT0283-2007)
YY/T 0283-2007: Large intestine fiber endoscope
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
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 Contents
Foreword ... 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 ... 26
This 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 Endoscope
This 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 references
The 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 testing
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. Test for in vitro cytotoxicity
GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. Tests for irritation and delayed-type hypersensitivity (ISO 10993-10. 2002, IDT)
YY 0466-2003 Medical devices - Symbols to be used with medical device labels labelling and information to be supplied (ISO 15223. 2000, IDT)
4.3.5 Light spot at working distance shall fill-cover the whole view-field, without obvious dark-light boundary.
Clear observation range. 5 mm~100 mm.
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.
4.4.2 Suction shall be smooth. There is no liquid ejected backward at the places of button and forceps channel socket. The suction flow must not be lower than 400 mL/min. 4.4.3 Suction tube shall be able to be washed by mild brush (only applicable to waterproof type).
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.
4.5.2 For upward and downward directions, the bend-angle of fiber endoscope shall be ≥ 180°; for left-ward and right-ward directions, it shall be ≥ 160°. When it is bent at any angle, the entry and exit of matching tools shall be smooth.
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.
4.7.2 There shall be direction-mark on top of filed.
4.7.3 Hand-wheel must have operation direction mark. The front bend direction shall be consistent with the marked sign.
The mechanical dimensions of fiber endoscope shall conform to Table 1.
Β -- View-field angle, unit. degree (°);
D -- Diameter of annulus, unit. mm;
L -- Distance BETWEEN the end-face of the centre of head-end window AND the centre of measuring target, unit. mm.
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
5.3.1 Water supply performance
Turn on the air pump according to the usage requirements (pressure is not greater than 50kPa; flow rate is not greater than 500 L/h) to conduct water supper operation. Use the measuring glass of which the minimum scale value is not greater 5mL and stopwatch to measure the volume of the supplied water within 1min in accordance with Article 4.4.1. GB/T 16886.5-2003. Cytotoxicity shall conform to the requirements in Article 4.9.1. 5.8.2 Sensitization shall be tested in accordance with the method specified in Chapter 6 of GB/T 16886.10-2005. It shall conform to the requirements in Article 4.9.2. 5.8.3 Stimulus response shall be tested in accordance with the method specified in Chapter 5 of GB/T 16886.10-2005. It shall conform to the requirements in Article 4.9.3. 5.9 Dissolved precipitate
For the test methods of dissolved precipitate, adopt the method specified in Annex C (Informative) or the equivalent method. It shall conform to the requirements in Article 4.10. 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 Artic...