《JIS-T-9233-1997-ENG.pdf》由会员分享，可在线阅读，更多相关《JIS-T-9233-1997-ENG.pdf（20页珍藏版）》请在三一文库上搜索。
1、JIS JAPANESE INDUSTRIAL STANDARD Translated and Published by Japanese Standards Association JIS T 9233 :1997 Testing methods for ostomy aids ICs 11.180 Reference number : JIS T 9233 : 1997 (E) PROTECTED BY COPYRIGHT 11 s Copyright Japanese Standards Association Provided by IHS under license with JSA
2、Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/16/2007 00:33:18 MDTNo reproduction or networking permitted without license from IHS -,-,- T 9233 : 1997 Foreword This translation has been made based on the original Japanese Industrial Standard established by the Minister of I
3、nternational Trade and Industry and the Minister of Health and Welfare, through deliberations at the Japanese Industrial Standards Committee in accordance with the Industrial Standardization Law: Date of Establishment: 1997-07-25 Date of Public Notice in O f f i c i a l Gazette: 1997-07-25 Investiga
4、ted by: Japanese Industrial Standards Committee Divisional council on Medical and Safety JE T 9233 : 1997, First hglich edition published in 2004-08 Translated and published by: Japanese Standards Association 41-24, k a k a , k t o - k u , Tokyo, 107-8440 JAPAN L n the event of any doubts arising as
5、 to the contents, the onginai JE i s to be the finaI authority. O JSA2004 Au. rights reserved. Unies otherwise qxdied, no part of t h i s publication may be rrproduced 01 utilized m any form or by any means, electrunic o r medunical, including photocopying and mimfilm, without permission m writing f
6、mm the pUbliSher. Printed i n Japan M&T PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/16/2007 00:33:18 MDTNo reproduction or networking permitted without license from IHS -
7、,-,- JAPANESE INDUSTRIAL STANDARD JIS T 9233 1997 Testing methods for ostomy aids 1 Scope This Japanese Industrial Standard dehes test methods for ostomy appliance, skin barrier disk (wafer, sheet, ring, roll) (hereafter referred to as “skin barrier”), and irrigation set among ostomy aids. Remarks 1
8、 The normative references of this Standard are shown below. JIS B 7503 J I S B 7516 JIS K 6250 JIS K 6253 JIS K 6258 JIS K 6718 JIS K 6735 JIS K 7100 JIS K 7126 JIS T 9232 JIS Z 0237 JIS Z 8102 JIS Z 8401 J I S Z 8802 Dial gauges Metal rules General d e s for physical testing methmk for rubber vulca
9、nized or Harhess testing method for rubber, vulcanized or thermoplastic Testing methods of the efect o f liqutds for vulcanizedrubber Polymethyl methmyIate sheets Polycarbonate sheets Standmd atmospheres for conditioning and testing ofplastics Testing method for gar tp.rmsmission rate tlpoughpIartic
10、$Im andsheeting Glossmy of t e m used in ostomy aids Testing methods ofpressure sensitive adhesive tapes andsheets Names o f non-luminous object colow-s Rules for rounding ofof numerical values Methoh for determination ofpHof aqueous solutions thermoplastic 2 The u n i t s and numerical values given
11、 in the traditional unit system and are appended for information. in this Standard are based on 2 Dehilions For the purposes of this Standard, the dehitions given in JIS T 9232 and the following defhitions apply. test volume the maximum volume obtained in a specifed test static durability the durabi
12、lity under the situation where the increase of load or the deformation velocity of a sample is extremity slow and the deformity progresses as the equilibrium between an external force and a stress are always kept engagement type bag junction portion the part at which a bag and fce plate engage by an
13、 engagement method adhesion a temporal adhesion, one type adhesion (a term generally used for permanent adhesion) adhesive property three basic physical properties expressed as adhesive power, tuck, and holding power PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS und
14、er license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/16/2007 00:33:18 MDTNo reproduction or networking permitted without license from IHS -,-,- 2 T 9233 : 1997 adhesive power a power produced by contact between an adhesive face and adherend peel adhesion a power
15、 needed to peal after a test fragment is pasted on a test plate and crimped of which measurement, a peel angle is 90 or 180 degrees tuck a adhesive power to an adherend in a short time by a very light power holding power a tolerable power of an adhesive against slippage when a static load is imposed
16、 to a longitudinal direction of an adherend and generally expressed as a distance which shifts in a certain time or a time which shifts with a certain distance deodorization o f ostomy bag a nature which prevents to permeate gas as a odor source produced b m feces or urine collected in a ostomy bag
17、and those changes (hydrogen suEde, mercaptan, scatol, ammonia, or others) test plate a plate having a certain quality, size, and surface condition used for measurement of adhesive power and holding power, made of stainless steels and also phenol resin laminates and acryl resin coating plate surh pH
18、hydrogen ion concentration at a skin side contacting with the surface of a skin barrier 3 Test method for ostomy aids Test items Measurement of test volume of ostomy bag Measurement and observation of thickness, form size, colour name, and transparency of ostomy bag Non-load static durability test o
19、f ostomy bag Load static durability test of ostomy bag Load static durability test of engagement type bag junction portion of two-piece ostomy appliance General adhesive propem test of skin contact side Deodorization test of ostomy bag 3.2 General conditions of the test 3.2.1 Standard conditions of
20、test place The test shall be conducted under the standard temperature condition second grade (23IZ“C) specified in 2.2 (standard temperature condition in difference grades) of JIS K 7100. 3.2.2 Standard conditions of a sample A sample shall be left for three hours or more under the standard conditio
21、ns of 3.2.1 before being provided for study. 3.2.3 rounded as shown in JIS 2 8401 and expressed in number of digits shown in table 1. Rounding method of test results The test results obtained in each test shall be PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under
22、license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/16/2007 00:33:18 MDTNo reproduction or networking permitted without license from IHS -,-,- 3 T 9233 : 1997 Test items Test volume ml Thickness P m Fom size cm ColOur name / transparency (sensory observation) Non-
23、load static durability of ostomy bag (cencory observation) Table 1 Rounding method of test results Test results obtained Integer number position Integer number position Integer number position Colou name, transp arency Presence or absence of water leak, time, Load static durabjiity of ostomy bag (se
24、nsory observation) Load static durability of twopiece type (sensory observation) place Presence or absence of water leak Presence or absence of water leak, time, General adhesive p r o p e m of c o n t a c t slnn side 180-degree peel adhesion N/cm(gacd Tilting ball t a c k Mibashi method N M Decdori
25、zing condition Permeability moUm2sPa an3/cmz24h.atm Permeabfity mfcient moIm/m%PaIcmWcmsdgl Holding power Uength of shppage) cfallingtime) Integer number position one digit after decimal point hteger number i position) three digits afkr deamal point three digits after decimal point mm min place doub
26、le - dipt &r decimal point b t e e r number) one &t after deumai point Integer number position 3 . 2 . 4 Records In test results, conditions used shall be recorded. 3.3 Measurement method of test volume of ostomy bag 3.3.1 Device An example of test equipment is shown in figurel. Making a set plate a
27、nd cleansing method of the surface shall be conducted as follows: (1) A set plate used shall be one with 5mm in thickness, 25cm in width, and 40cm in length specified in JIS K 6718 for general use or JIS K 6735 for general use. (2) A set plate has a n inflow hole of 1 O m m in diameter at the positi
28、on of 13cm &om the top edge and the centre of the width direction. A flexible tube of 10 mm in internal diameter is connected through a three-directional valve. The set plate is held vertically and a fine line is drawn through the centre of the innow hole horizontally see figure 1(21. (3) Ethanol (
29、1 ) is applied to the surface of the set plate and the surface is wiped off by a new gauze or others (2). After drymg the surface, ethanol is applied to it again and then it is wiped off by a new gauze or others t i l l its drying completely. This procedure is repeated three times or more until the
30、surface is evaluated to become clean. In addition, precautions must be taken against the following matters on use. (a When dirt on the surface of the set plate doesnt disappear, it should not be used. (b) Cleansing procedures of the surface of the set plate should be conducted at each test. Notes (1
31、) (2) Use one for test Use one in which fibres will not cut, or short fibres will not be eliminated and additives being soluble in ethanol (l are not contained. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, Us
32、er=Wing, Bernie Not for Resale, 03/16/2007 00:33:18 MDTNo reproduction or networking permitted without license from IHS -,-,- 4 T 9233 : 1997 (U Device o Set plate Test water I Flexibie tube I4 I Thiee-oIlalvalve U :Testwater Figure 1 A test volume measurement device of ostomy bag 3 . 3 . 2 Preparat
33、ion (1) Preparation of samples The preparation of samples shall be conducted as follows. (d As for an ostomy appliance in which an ostomy hole of 10mm or more in diameter is not made at skin side, an ostomy hole of 10mm in diameter is made at the centre of skin side. (b) A two-piece ostomy appliance
34、 is connected and installed by a method recommended by the manufacturer or distributor. (cl In the case of non-adhesive ostomy appliance, to prevent fluid leak by inflow of test water coloured with methylene blue, an adhesive or both-side adhesive tape is used. (d In the case of an ostomy appliance
35、having a bottom open-ended ostomy bag, the appliance is closed by a method recommended by the manufacturer or distributor. However, the closed position must be at 3I0.5cm from the lower edge of the appliance. (e) A l l air contained in an ostomy appliance is exhausted However, an air retained for us
36、ual use such as molded article part doesnt need to be exhausted. In the case of presence of flatus vent, the part is closed to prevent leak of test water with an adhesive tape or others. (0 (2) Installation of a sample In an ostomy appliance, a fine line is drawn horizontally through the centre of a
37、n ostomy hole at skin side. A sample is installed in such a manner that this fine line and the fuie line of the set plate come in succession and the ostomy hole of skin side and the inflow hole of the set plate become concentric circular. 3 . 3 . 3 Procedures (1) The plate set an ostomy appliance is
38、 weighed with the accuracy of il g. ( 2 ) A test fluid is infused fiom a flexible tube at the flow velocity of 25k5 d s . PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/16/2
39、007 00:33:18 MDTNo reproduction or networking permitted without license from IHS -,-,- 5 T 9233 : 1997 (d In the case of an ostomy appliance without check-valve, the test water is infused up to the centre of the ostomy hole. (b) In the case of an ostomy appliance with a check-valve, the storage port
40、ion under the check-valve is Ued in the test water and the water is then infused up to lcm above the check-valve. (3) The tube is removed and the appliance filled with the test water is weighed with the accuracy of +lg in each set plate. (4) The test volume is obtained Fom the weighing difference be
41、tween (1) and (3), with 1 as the density of the test water. 3.3.4 Records As for measurement results, the following matters shall be recorded. (1) Name of a sample (2) Measurement results (3) Year, month, and day of measurement (4) Other necessary matters 3.4 Measurement and observation of thickness
42、, size, colour name, and transparency i n an ostomy bag 3.4.1 Thickness The thickness in an ostomy bag(3) shall be measured as follows. Note (3) The thickness used here shall mean the thickness when a certain force is added while a single layer of the ostomy bag is put between two parallel disks of
43、the measurement device. (i) Measurement instmments and method The thickness gage shall have the division of 0.001mm and smooth pressure face and be circular with 510.01 mm in diameter. The pressure of the thickness gage shall be 0.123 6 Ni125 g $ as a principle and shall not be allowable to change b
44、y +15 % or more within the measurement range. When a dial gage is used, a gage with the accuracy of dial gage specified in J E B 7503 or equivalent or better accuracy shall be used. (2) Measurement site The thickness shall be measured at five sites which are apart fiom the single layer of the ostomy
45、 bag as much as possible and the mean value shall be obtained. In addition, when the bag is structured with two kinds of materials or more, each structural material shall be measured. 3.42 s i z e (1) Measurement inctrument The measurement instrument shall have the accuracy of the first degree scale
46、 speded in JIS B 7516 or equivalent or better accuracy. (2) Measurement position The measurement positions are shown in e 2. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/1
47、6/2007 00:33:18 MDTNo reproduction or networking permitted without license from IHS -,-,- 6 T 9233 1997 Side Figure 2 Measurement positions of sizes (3) Measurement method A sample is placed on a horizontal plate and measured. However, in the case of folded type ostomy bag, the length when both the
48、sides are extended shall be measured. As for ostomy appliance having an initial hole or existing hole, the calibre shall be measured. In addition, when this hole is not circular, the long and short diameters shall be measured. (4) Records As for measurement results, the following matters shall be recorded. (a) Names of samples (b) Measurement results (cl Year, month, and day of measurement (d Other necessary matters 3.4.3 Colour name and transparency (1) Observation method It shall be a visual observation. (2) Division of colour names It shall be according to JIS