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1、UDC 615.473.3 JIS JAPANESE I NDUSTRIAL STANDARD Glass Syringes 31s T 3201-1979 (Reaffirmed: 1985) -: - - , Translation without guarantee I In the event of any doubt arising, the original I I I I standard i n Japanese is to be evidence Translated Japanese Standards Association 1-24, Akasaka 4, Minato
2、-ku Tokyo 107 Japan 0 JSA, lg87 PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/11/2007 00:17:41 MSTNo reproduction or networking permitted without license from IHS -,-,- UDC
3、 615473.3 JAPANESE INDUSTRIAL STANDARD Glass Syringes 1, Scope J I S T 3201-1979 (Reaffirmed: 1985) This Japanese Industrial Standard specifies medical syringes made mainly of glass, hereinafter referred t o as the “syringes“. Remark: The units and numerical values shown i n braces in t h i s standa
4、rd are based on the International System of Units (SI), and are appended for reference. 2. Classification 2.1 Classification by Material and Shape of Cylinder Tip Syringes shall be classified as follows by the material and shape of the cylinder tip. (1) Ground-glass joint tip( 1 (2) Metal tip(2) (3)
5、 Lock type t i p ( 3, Notes (I) The t i p is made of the same glass as that of the outer cylinder. The t i p is made of metal and has the same shape as the ground-glass tip. The t i p is made of metal and has a cut groove construction which guides the flange at the root of the injection needle. ( 2
6、) ( 3 ) 2.2 Classification by Fitting Position of Cylinder Tip Syringes shall be classified as follows by the position of f i t t i n g the cylinder tip. (1) Concentric mouth(4 ). (2) Eccentric mouth( 1. Notes (4) The centre lines of the cylinder t i p and outer cylinder agree with each other. (1 Th
7、e cylinder t i p is attached at a position as shown i n Fig. 1. Fig. 1. Eccentric Mouth PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/11/2007 00:17:41 MSTNo reproduction or
8、 networking permitted without license from IHS -,-,- 2 T 3201-1979 20 2.3 Classification by Marking Method for Scale Marks, etc. Syringes shall be classified as follows by the marking method for 1, 2 scale marks and the like. For dental use 2 m l (i) Printing. 75 ( 2 ) Etching. 2.4 Classification by
9、 Use, Capacity, and Outer Cylinder Length Syringes shall be classified as shown i n Table 1. Table 1. Classification by Use, Capacity, and Outer Cylinder Length Class Length ( mm 2 m l 3 m l 5 m l 10 m l 20 ml 30 m l 50 m l 100 m l 55 65 75 95 100 120 130 160 For minute 1 m i For minute T1 mi(7) For
10、 minute 2 m l quant it y quant it y quant it y 85 85 90 Scale Tumber of xale marks Scale figures m l 20 30 25 25 20 30- 50. 50 1, 2 1, 2, 3 1, 2, 3, 4 , 5 2, 4, 6, 8, 10 5, 10, 15, 20 10, 20, 30, 10, 20, 30, 40, 50 20, 40, 60, 80, 1OC 100, 1 20, 40, 60, 80, 1 40 112, 1, 1-1/2, 2 Ioler- snc e s + 5 %
11、 - + 2 % - + 5 % - Notes ( 6 The length indicates the standard value and does not include the cylinder t i p length. T 1 m l is for tuberculin. (1 Remark: Exclusively i n the case of products for export, where particularly specified by the purchaser with respect t o the class, outer cylinder length,
12、 number of scale marks, and scale figures, these items may be altered based on this standard. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/11/2007 00:17:41 MSTNo reproduct
13、ion or networking permitted without license from IHS -,-,- 3 T 3201-1979 3. Performance 3.1 Scale When a test is performed by the method of 6.4, the requirements of Table 1 shall be satisfied. 3.2 Airtightness When a test is performed by the method of 6.5, no water drops shall f a l l from the engag
14、ing part. 3.3 Alkali Dissolution Degree When a test is performed by the method f o 6.6, the solution shall not turn pink. 3.4 Adhesion of Metal Cylinder Tip When a test is performed by the method of 6.7, the cylinder t i p shall not detach from the outer cylinder. 3.5 Thermal Shock When a test is pe
15、rformed by the testing method of 6.8, there shall not occur cracking due t o changes i n humidity and i n the case of metal cylinder tip, the cylinder t i p shall not detach or loosen. 3.6 Pressure Resistance Strength When a test is performed by the testing method of 6.9, there shall not occur crack
16、ing due t o changes i n pressure. 4. Appearance and Construction Syringes shall consist of an outer cylinder and a sucker, and their appearance and construction shall be as follows: Those parts made of glass shall be free from remarkable seams, foams, cuts, and other defects. The outer cylinder shal
17、l be marked at least with the scale marks and scale figures, specified i n Table 1. For interchangeable outer cylinders, a symbol indicating interchangeability shall be marked and for non-interchangeable ones, the collation number shall be marked on the outer cylinder and sucker. The scale marks, sc
18、ale figures, collation number, or the l i k e shall be distinctly marked by an indelible method. Metal cylinder t i p s shall have smooth finished surfaces, and brass cylinder tips shall be plated with nickel o r chromium. When the injection needle is f i t t e d t o the cylinder tip, the centre lin
19、e of the needle tube of the injection needle shall agree with that of the outer cylinder i n the case of concentric mouth type, and shall be parallel t o o r slightly inclined against the centre l i n e of the outer cylinder i n the case of eccentric mouth type. PROTECTED BY COPYRIGHT Copyright Japa
20、nese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/11/2007 00:17:41 MSTNo reproduction or networking permitted without license from IHS -,-,- 4 T 3201-1979 Class (6) The flange of the outer cylinder shall be of the
21、 double flange type and be able to rest stably on a flat plate. Cylinder tip length mm 5. Dimensions 5.1 Cylinder Tip Length The cylinder tip length shall be as shown in Table 2. i to 20 mi I 1 1 + 2 - 14 + 2 - 30 to 100 ml 5.2 Length of Taper-Finished Part The length of the frosted part of the cyli
22、nder tip in the case of ground-glass cylinder tips, and the length of the taper-finished part at the end in the case of metal tips shall be not smaller than 6.5 mm. A roundness within 0.4 mm may be provided at the end. 5.3 Distance between Flange Root and Sucker End In the case of syringes for denta
23、l use, the distance between the flange root and sucker end when the sucker is pushed into the outer cylinder shall be 25 + 3 mm. - 5.4 Gauge Dimension of Cylinder Tlp When a test is performed by the testing method of 6.3 (21, the taper of the cylinder tip and that of the gauge shall agree, and the e
24、nd of the cylinder tip shall be within the limit of the gauge. 6 . Testing 6.1 Test Items The test items for syringes shall be as follows; (1) Appearance and construction inspection (2) Dimsnsional inspection (3) Scale test ( 4 ) Airtightness test ( 5 ) Aikali test (6) Pull-out test of metal cylinde
25、r tip (7) Thermal shock test ( 8 ) Pressure resistance test PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/11/2007 00:17:41 MSTNo reproduction or networking permitted withou
26、t license from IHS -,-,- 5 T 3201-1979 6.2 Appearance and Construction Inspection Visual inspection shall be performed for the items of 4 . 6.3 Dimensional Inspection The following procedure shall be performed: (1) Inspect the cylinder tip length of 5.1, the length of taper-finished part of 5.2, and
27、 the distance between the flange root and the sucker end of 5.3. (2) Using the inspection gauge shown in Fig. 2 for ground-glass tip and metal tips, and using that shown in Fig. 3 for lock type tips, push the gauge into the cylinder tip under a slight pressure to examine whether the taper of the cyl
28、inder tip and that of the gauge agrees or not. examine whether the end of the cylinder tip is within the limit of the gauge or not. Then, if they agree, Fig. 2 . Inspection Gauge Fig. 3. Inspection Gauge Unit: mm Unit: mm Within 2.3 Zi370 I 0.0025 - 8-, c - 6.4 Scale Test After sucking water to the
29、maximum scale mark of the syringe, the water shall be forced out to the zero scale mark and the quantity of discharged water measured, and thereby the error relative to the maximum scale quantity shall be obtained. 6.5 Airtightness Test The following procedures shall be performed: Suck water into th
30、e syringe, thoroughly freed from water by wiping, the maximum scale mark and to the position corresponding to 1/4 of the maximum scale, respectively, then fix the horizontally held outer cylinder and sucker and apply the pressure specified in Table 3 from the cylinder mouth for 10 sec, and examine w
31、hether water drops fall from the engaging part between the outer cylinder and the sucker. procedure, perform a test by fixing the outer cylinder and blocking the cylinder mouth to prevent water from escaping and then applying the pressure to the sucker. However, where the test cannot be performed by
32、 this PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/11/2007 00:17:41 MSTNo reproduction or networking permitted without license from IHS -,-,- 6 T 3201-1979 Pressure i n ai
33、rtight- ness test kgf/cm (MPa Class Table 3 Liquid quantity i n alkali test m l I I For dental use 2 m l 4.0 0.39 200 2 m l 3 m l 5 m l 10 m l 20 m l 30 m l 50 m l 100 m l 3.0 (0.29 2.5 (0.2451 2.5 (0.245) 2.0 (0.196) 1.8 (0.1771 1.5 (0.147) 1.5 (0.147) 1.2 0.118) 100 200 20 o 300 400 600 600 1000 F
34、or minute quantity 1 m l For minute quantity T 1 m l For minute quantity 2 m l 4.0 0.39 4.0 0.39 3.0 0.28 200 200 250 6.6 Alkali Test The following procedures shall be performed: Place the outer cylinder and sucker i n a container, such that the distilled water contained can be kept neutral even aft
35、er boiling for one hour, then add distilled water of a quantity necessary t o completely immerse the outer cylinder and sucker and boil for 30 min, and after letting cool t o about room temperature, increase the liquid quantity t o the value shown i n Table 3, then drop 1 t o 3 drops of 1 % phenolph
36、thalein reagent solution specified i n the Japanese Pharmacopoeia, and examine whether the solution turns pink at room temperature or not. tip, perform the test a f t e r removing the t i p and adhesives. However, i n the case of a syringe having a metal 6.7 Pulling-out Test of Metal Cylinder Tip Wi
37、th the syringe fixed, a load of 8 kgf (78 N) shall be applied t o the metal cylinder t i p toward the pull-out direction for 5 minutes t o examine whether the cylinder t i p detaches from the outer cylinder or not. Where the fixing of the cylinder t i p has loosened as a result of the above test, ju
38、dgment shall be made that the t i p has detached from the syringe. 6.8 Thermal Shock Test The following procedures shall be performed: After boiling the separated outer cylinder and sucker for 3 min, promptly place them i n water at 10 t o 15“C, and leave them standing for 3 minutes. Continuously re
39、peat this operation 5 times and examine whether there occurs cracking due t o changes i n temperature, and i n the case of a metal-tipped syringe, whether the t i p drops off or loosens or not. 6.9 Pressure Resistance T e s t The outer cylinder with the sucker assembled with it shall be placed i n a
40、n autoclave and withdrawn after application of a steam pressure of 1.05 kgf/cm3 0.103 MPa at 121.5“C for 15 min, and examination shall be made for the occurrence of cracking due t o changes i n pressure. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license wi
41、th JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/11/2007 00:17:41 MSTNo reproduction or networking permitted without license from IHS -,-,- 7 . T 3204-1979 7. Designation of Product Syringes shall be designated by the product name and class. Example: Glass syringe, groun
42、d-glass tip, concentric mouth, for medical use, 2 ml, 8. Marking The outer cylinders of syringes shall be marked with the trade mark of the manufacturer, and packages of syringes shall be marked with the following items of information: (1) Product Name This may be indicated in English. (2) Classific
43、ation (excluding the classification by marking method for scale marks, etc.) However, classification marks may be omitted for the following products. classification may be made in English. The marking of (a) Ground-glass tip syringes, in the classification according to material and shape of cylinder
44、 tip. (b) Concentric mouth syringes of capacities within 5 ml, in the classification according to tip fitting position. (c) Syringes for general medical treatment, in the classification according to use. (3) Manufacturers Name and Address PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/11/2007 00:17:41 MSTNo reproduction or networking permitted without license from IHS -,-,-