YY 1082-2007 English PDF (YY1082-2007)
YY 1082-2007 English PDF (YY1082-2007)
See Chinese contents: YY 1082-2007
YY 1082-2007: Rigid arthroscope
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Replacing YY 91082-1999
ISSUED ON: JULY 02, 2007
IMPLEMENTED ON: MARCH 01, 2008
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Composition ... 5
4 Requirements ... 5
5 Test methods ... 8
6 Inspection rules ... 16
7 Signs, labels and instruction manual ... 18
8 Packaging, transportation, storage ... 19
Appendix A (Normative) Safety requirements for interconnection with medical electrical equipment ... 20
This standard specifies the classification and marking, requirements, test methods, inspection rules, signs, labels and instruction manual, packaging, transportation, storage of rigid arthroscopes.
This standard is applicable to rigid arthroscope (hereinafter referred to as arthroscope). Arthroscope is suitable for the examination and diagnosis of human joint diseases in medical clinics, as well as for treatment together with relevant surgical systems.
2 Normative references
The provisions in following documents become the provisions of this standard through reference in this standard. For the 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 191-2000 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/T 6463-2005 Metallic and other inorganic coatings - Review of methods of measurement of thickness
GB 9706.1-1995 Medical electrical equipment - Part 1: General
requirements for safety (idt IEC 601-1:1988)
GB 9706.19-2000 Medical electrical equipment - Part 2: Particular
requirements for the safety of endoscopic equipment (idt IEC 60601-2-
GB 11244-2005 General requirements for the medical endoscope and
GB/T 14710-1993 The environmental requirements and test methods for
medical electrical equipment
flowrate of water shall be not less than 200 mL/min.
4.8 The head of the puncture needle shall be smooth and sharp, the head of the blunt obturator shall be smooth and round, the handle of the needle of the instrument shall be flat and smooth.
4.9 The inner hole of the instrument puncture cannula shall be clean and smooth, which may allow the instrument puncture needle and the matching surgical instruments to pass smoothly.
4.10 The hardness of the tip of the puncture needle and the instrument puncture needle shall be HRC 36 ~ 46.
4.11 The welded parts of the arthroscope shall be firm and reliable, flat and smooth, there is no insufficient welding or surfacing.
4.12 The plating of arthroscope’s plated components shall comply with the category-V grade-2 requirements of YY 0076-1992.
4.13 Arthroscope is a medical device that is in short-term contact with the injured surface. The outer surface material of the insertion part shall be made of materials that have been proven to be biocompatible. Otherwise, the
following tests shall be carried out:
a) The cytotoxicity score shall be not more than 1;
b) The type of stimulus reaction shall be not more than mild;
c) There shall be no sensitization.
4.14 The safety requirements for the interconnection and use with medical electrical equipment:
The arthroscope shall comply with the requirements of GB 9706.1-1995 and GB 9706.19-2000. See Appendix A (Normative) for specific requirements.
4.15 The environmental test of arthroscope shall meet the requirements of Group-2 of the climatic environmental conditions, Group-2 of mechanical environmental conditions and Table 3 in GB/T 14710-1993.
Table 3 -- Environmental test requirements and inspection items
Test item Test conditions
Test requirements Inspection items
time / h
5 °C 1 - -
4.2 ~ 4.11,
Fr - The equivalent perimeter, in millimeters (mm);
U - The minimum length of the externally-tangent curve, in millimeters (mm). 5.3 Basic parameters of endoscope
5.3.1 Field of view and angle of view
22.214.171.124.1 The measuring instrument consists of the following parts:
a) Optical bench or similar device, which can support the endoscope for testing, it may adjust the optical axis of the endoscope to coincide with the center of the measuring target. At the end surface of the endoscope’s
head, measure the field of view at a point along the perpendicular direction 50 mm from the center point of the measuring target of the concentric
circle where the angle is marked;
b) The target holder and the dial divided by “degrees” (see Figure 1);
c) Measuring target for the measurement of field of view and angle of view (see Figure 2): circular, with a set of measurements in unit of “degree”, measured at 50 mm. The ring of the measuring target may be calculated
according to the formula (2):
D - The diameter of the measuring ring corresponding to different angles of view, in millimeters (mm);
β - Field of view, in degrees (°).
The measuring target is fixed on the instrument.
There shall be a main marking line every 10°, as well as the corresponding degree indications.
A line shall be marked every 2° between each main marking line, 4
marking lines in total.
d) Lighting shall be measured by white-light-illuminated measuring target, the minimum illuminance is not less than 500 lx, it may use an endoscope or external light source.
126.96.36.199.2 The following test methods are only recommended:
Fix the endoscope and adjust the distance between the objective lens and the object to be observed. When the distance is at two positions: 1 mm and 50 mm, it may clearly observe a 1.2 mm width line through the endoscope’s eyepiece, which shall comply with the requirements of clause 4.4.
5.4 Endoscope’s performance
5.4.1 Defect and light spot of field of view
Turn on the cold light source and adjust to the brightest state. Observe the illuminated white paper through the endoscope, which shall meet the
requirements of 4.5.1 and 4.5.5.
5.4.2 Test of half-unshielded eyepiece cover
Test according to the method of 5.5 in GB 11244-2005, the results shall meet the requirements of 4.5.2.
5.4.3 Test of fog layer
Insert the insertion part of the endoscope into water which has a temperature of 20 °C or less. After 10 min, take it out. Then insert it into water which has a temperature of 40 °C. Take it out and wipe it dry. Observe from the eyepiece, it shall meet the requirements of 4.5.3.
5.4.4 Sealing test
Test according to the method in YY 0068-1992, the results shall meet the requirements of 4.5.4.
5.4.5 Illuminance uniformity
Place the illuminometer probe at a distance of 50 mm in front of the endoscope. According to the angle of view of the endoscope, adjust the illuminometer probe, to make it perpendicular to the view direction of the endoscope.
At the point A (A is the center of the field of view at the object side) in Figure 4, use the illuminometer to measure the illuminance at that point, which is the illuminance value E0 of the center of the field of view.
The illuminance at the edge of the field of view is measured at points B1, B2, B3, B4 in Figure 4. In Figure 4, it divides the field of view at the object side into four quadrants, each quadrant contains one measurement point, namely B1, B2, B3, B4 (the four points are 70% of the field of view at the object side). Use the illuminometer to measure the illuminance at each point, which is the illuminance value at the edge of the field of view and recorded as E1, E2, E3, E4, respectively. The calculated values of E1/E0, E2/E0, E3/E0, E4/E0 shall all comply with the 350 mm.
The test of the thickness and mass of the plating shall be carried out in accordance with the provisions of GB/T 6463-2005 and the corresponding
inspection methods, the results shall comply with the requirements of 4.12. 5.10 Evaluation of biocompatibility
Check the relevant evidence of biocompatibility, which shall meet the
requirements of 4.13. Otherwise the test is carried out as follows:
a) It is carried out according to the method as specified in GB/T 16886.5- 2003, the results shall meet the requirements of 4.13 a);
b) It is carried out according to the method as specified in GB/T 16886.10- 2005, the results shall meet the requirements of 4.13 b) and c).
5.11 Safety requirements for interconnection with medical electrical
It is carried out according to the method as specified in Appendix A (Normative), the results shall comply with the requirements of 4.14.
5.12 Environmental test
Test according to the test sequence and test method in GB/T 14710-1993 as well as the requirements of 4.15, the results shall comply with the requirements of 4.15.
6 Inspection rules
Arthroscope may only be exit-factory after passing the inspection by the quality inspection department of the manufacturer and being accompanied with the product quality inspection certificate.
6.2 Classification of inspections
Arthroscopic inspection is divided into exit-factory inspection and type inspection.
6.3 Exit-factory inspection
6.3.1 The exit-factory inspection of arthroscope shall be carried out one by one, the inspection items are 4.2 ~ 4.9, 4.11, as well as the exit-factory inspection items as specified in clause A.8, clause A.9, YY 0068.
e) Any changes in the final product during the storage period;
f) When the use of the product changes;
g) When there are indications that the product will have an adverse effect if applied to the human body.
6.5.2 When conducting biocompatibility tests, take samples according to the requirements of inspection, they shall be all qualified.
7 Signs, labels and instruction manual
7.1.1 Each component of the arthroscope shall be identified of the product code, trademark or corporate sign.
7.1.2 The endoscope of arthroscopic shall indicate the maximum outer diameter of the insertion part, the minimum inner diameter of instrument channel, the angle of view, the field of view, the working length, etc.
7.1.3 If it cannot mark the arthroscope due to the size or shape, it shall be partially marked in the package or instruction manual.
7.1.4 For endoscopes that are capable of subject to pressure vapor sterilization, it shall mark the words “autoclave” on the prominent position of the endoscope. 7.1.5 The outer packaging shall have the following signs:
a) The name of manufacturer;
b) The product name and model number;
c) The year and month of exit-factory;
d) The volume (length x width x height);
e) The net weight;
f) The gross weight;
g) The product standard number;
h) The registration number;
i) The words of “fragile items”, “upwards”, “keeping away from rain” as well as the signs as specified in GB/T 191-2000 and YY 0466-2003.
Safety requirements for interconnection with medical electrical
A.1 Product characteristics
Arthroscope is the BF-type application part of endoscopic electrical equipment. A.2 External mark
It shall have the following markings which are permanently adhered and clearly identifiable:
a) Corporate sign;
b) Product model or code.
A.2.2 Test methods
Use the method as specified in clause 6.1 of GB 9706.1-1995 to carry out inspection and test.
A.3 Completeness of accompanied file
It shall comply with the provisions of 6.8.1 of GB 9706.1-1995.
A.3.2 Test methods
Check the accompanied file.
A.4 Instruction manual
It shall comply with the provisions of 6.8.2 a) and d) of GB 9706.1-1995, meanwhile it shall comply with the provisions of 6.8.2 aa) and bb) of GB 9706.19-2000.
A.4.2 Test methods
equipment, it has no requirement for this clause.
The wet pretreatment shall be carried out according to 4.10 in GB 9706.1-1995. The continuous leakage current test after wet pretreatment shall be carried out by the leakage current tester according to the provisions of 19.4 h) of GB 9706.1-1995. It is required to connect the matching cold light source for testing, the measurement circuit is as shown in Figure 21 and Appendix K of GB 9706.1- 1995.
A.11 Dielectric strength after wet pretreatment
According to the provisions of Table A.2, between the specified parts, it shall be able to withstand 50 Hz, sine wave and the specified test voltage for 1 min, without breakdown or flashover.
A.11.2 Test methods
The wet pretreatment is carried out according to 4.10 in GB 9706.1-1995. The dielectric strength test after wet pretreatment is carried out according to the provisions of 20.4 of GB 9706.1-1995, using the parameter tester of electric shock protection to test the medical electrical equipment.
A.12 Safety of face, corner, edge
It shall meet the requirements of clause 23 of GB 9706.1-1995.
A.12.2 Test methods
Carry out visual observation and hand-touching inspection.
A.13 Protection of over-temperature hazard
It shall meet the requirements of 42.3 in GB 9706.1-1995 and 42.3 in GB 9706.19-2000.
A.13.2 Test methods
It is carried out according to the method as specified in 42.3 of GB 9706.1-1995 and 42.3 of GB 9706.19-2000.
A.14 Cleaning, disinfection and sterilization