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YY 1028-2008 English PDF (YY1028-2008)

YY 1028-2008 English PDF (YY1028-2008)

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YY 1028-2008: Upper gastro intestinal fiberscope

This Standard specifies upper gastro intestinal fiberscope classification, basic parameters, technical requirements, test method, inspection rules, marking, packaging, transportation and storage requirements.
YY 1028-2008
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040
C 40
YYY 1028-2008
Replacing YY 91028-1999
Upper gastro intestinal fiberscope
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Issued by. China Food and Drug Administration
ISSUED ON. OCTOBER 17, 2008
IMPLEMENTED ON. JUNE 01, 2010
Table of Contents
Foreword ... 3
Upper Gastro Intestinal Fiberscope ... 4
1 Scope ... 4
2 Normative References ... 4
3 Product classification ... 5
4 Requirements ... 5
5 Test methods ... 10
6 Inspection rules ... 17
7 Labels, marks and operation instructions ... 19
8 Packaging, transportation and storage ... 20
Foreword
This Standard is the revision of YY 91028-1999 ?€?Upper gastro intestinal fiberscope?€? according to GB 11244-2005 ?€?General requirements for the medical endoscope and endoscope accessories?€?.
This Standard replaces YY 91028-1999 ?€?Upper gastro intestinal fiberscope?€?. The main difference between this Standard and YY 91028-1999 is. it adds the requirements of biological compatibility of touching body parts.
The electrical safety test of this Standard mandatorily executes GB 9706.1-2007 ?€?Medical electrical equipment - Part 1. General requirements for safety?€? and GB 9706.19-2000 ?€?Medical electrical equipment - Part 2. Particular requirements for the safety of endoscopic equipment?€?.
The environmental test of this Standard excites GB/T 14710-1993 ?€?The environmental requirements and test methods for medical electrical equipment?€?.
The Appendix A of this Standard is normative.
This Standard was proposed by and shall be under the jurisdiction of National Technical Committee on Optics and Optical Instruments Standardization Administration Subcommittee on Medical Optics and Instrument (SAC/TC 103/SC 1).
This Standard is drafted by Hangzhou Medical Equipment Quality Supervision and Inspection Centre of State Drug Administration.
Main drafters of this Standard. Mao Xinxin, He Tao, Yan Qinglai, Jia Xiaohang, and Ma Jun.
Upper Gastro Intestinal Fiberscope
1 Scope
This Standard specifies upper gastro intestinal fiberscope?€?s classification, basic parameters, technical requirements, test method, inspection rules, marking, packaging, transportation and storage requirements.
This Standard applies to upper gastro intestinal fiberscope series products, which are used for diagnosis or treatment of oesophagus, stomach and duodenum.
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 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety
GB 9706.19-2000 Medical electrical equipment - Part 2. Particular requirements for the safety of endoscopic equipment
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
GB/T 14233.1-1998 Infusion, transfusion, injection equipment for medical use - Part 1. Chemical analysis methods
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
4.3 Water and air carrying system
4.3.1 Water and air carrying shall be unobstructed; objective lens window surface shall be able to be washed during water carrying; water carrying volume shall not be less than 40 mL/min; air carrying amount shall not be less than 800 mL/min.
4.3.2 Water and air carrying buttons shall be tilted freely without jamming. 4.3.3 Junctions of water and air carrying system shall match properly, be well-sealed and have no leak phenomenon.
4.4 Suction and forceps channel system
4.4.1 Suction shall be smooth; there shall be blowout preventer against fluid in cavity of human body. During imbibition operation, there shall be no fluid back-spray phenomenon at blowout preventer and suction button.
4.4.2 Suction volume must not be less than 400 mL/min.
4.4.3 Suction button shall be tilted freely without jamming.
4.5 Bending-angle operating system
4.5.1 During corner handwheel is in operation, it shall be handy and flexible, and have no intermittent-tightness or intermittent-looseness or jamming phenomenon. 4.5.2 Bending-angle locking mechanism shall be able to lock the handwheel; Unlocking of fixed bending-angle does not affect the operation function of bending-angle handwheel. 4.5.3 When fibber bending-angle part is bent into the maximum angle, the biopsy forceps, snare, etc. can smoothly enter and exit from forceps channel of head-end. 4.5.4 Limit deviation of bending-angle dimension is ?€? 10% (excluding upper limit). 4.6 Sealing performance
4.6.1 Upper gastro intestinal fiberscope is put into water in whole; its inner cavity can withstand 22 kPa intensity of pressure for 3 min without leakage (applicable to waterproof type).
4.6.2 Upper gastro intestinal fiberscope is used at a temperature range of 10 ??C ~ 40??C. Surface of optical element shall not have fog layer due to changes of temperature that may affect observation.
4.7 Matching with accessories
4.7.1 When upper gastro intestinal fiberscope is connected with corresponding accessory connector, there shall be good matching and free handling, without too tight or too lose into water, until lens-body is fully immersed in water. Turn the corner handwheel upward and downward to bend; bend for 3 times in each direction; there shall be no air bubbles from lens-body within 3 min after stabilization; it shall conform to the requirements of 4.6.1.
Note. Due to the air in external gap, some bubbles may emerge at the beginning of immersion, which is a normal phenomenon.
5.3.10 Haze test
Insert the insertable part of upper gastro intestinal fiberscope into water at 10??C; then take out; immediately insert into water at 40??C. Observe with eyepiece after taking out; it shall conform to the provisions of 4.6.2.
5.3.11 Water and air carrying performance test
Water and gas carrying performance test shall be conducted as follows.
a) Turn on the electromagnetic air pump to perform water and air carrying operation; b) Use measuring cup of which the division value is 5mL and stopwatch to measure water carrying volume; use air flow meter of which the precision is grade 2.5 to measure air flow; it shall conform to the provisions of 4.3.1;
c) During water and air carrying test, sealing performance of system junctions shall conform to the provisions of 4.3.3;
d) Repeatedly press-release the water-air button; the mechanical properties shall conform to the provisions of 4.3.2.
5.3.12 Suction test
Suction test shall be conducted as follows.
a) Immerse the head-end of upper gastro intestinal fiberscope into water; set intensity of pressure of suction pump to not greater than 70kPa;
b) Use measuring cup of having a division value of 5mL and stopwatch to measure suction amount; it shall conform to the provisions of 4.4.2;
c) Repeatedly press-release the suction button; its mechanical properties shall conform to the provisions of 4.4.3.
d) During the above operation, there shall be no water sprayed from forceps channel opening, which shall conform to the provisions of 4.4.1.
5.3.13 Cooperating performance with surgical instruments
Insert the matched biopsy forceps into forceps hole; biopsy forceps shall be within the view-field of upper gastro intestinal fiberscope, move freely and have no stuck-sluggish phenomenon, which shall conform to the provisions of 4.7.1 and 4.7.2.
5.4 Use common-use measuring tool or dedicated measuring equipment to measure, which shall conform to the provisions of 4.9.
5.5 Conduct according to the method specified in GB 9706.1-2007 and GB 9706.19-2000, which shall conform to the provisions of 4.10.
5.6 Conduct according to the method specified in GB/T 14710-1993, which shall conform to the provisions of 4.11.
6 Inspection??rules
6.1 General rules
Upper gastro intestinal fiberscope shall pass the inspection by quality inspection department of the manufacturer, and be accompanied with product quality inspection certificate before delivery.
6.2 Group-batch rules
Products of the same-model, produced through one-time material feeding are deemed as a batch; products are inspected batch by batch.
6.3 Inspection classification and inspection items
6.3.1 Inspection is divided into exit-factory inspection and type inspection. 6.3.2 Exit-factory inspection must be carried out when the products are delivered. 6.3.3 Periodical inspection must be carried out under following circumstances. a) Before new products are launched into...

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