JIS-T-9205-2001-ENG.pdf

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1、J IS JAPANESE INDUSTRIAL STANDARD Translated and Published by Japanese Standards Association Manually operated hospital gatch bed ICs 11.140 Descriptors : hospital equipment, beds, bedding Reference number : JIS T 9205 : 2001 (E) PROTECTED BY COPYRIGHT 12 s Copyright Japanese Standards Association P

2、rovided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 21:54:50 MDTNo reproduction or networking permitted without license from IHS -,-,- T 9205 : 2001 Foreword This translation has been made based on the original Japanese Industrial Stan

3、dard revised by the Minister of Economy, Trade and Industry through deliberations at the Japanese Industrial Standards Committee, as the result of proposal for revision of Japanese Industrial Standard submit- ted by Healthcare Engineering Association of Japan (HEAJ)/Japanese Standards Association (J

4、SA) with the draft being attached, based on the provision of Article 12 Clause 1 of the Industrial Standardization Law applicable to the case of revision by the provision of Article 14. Conse- quently JI$ T 9205 : 1994 is replaced with this Standard. For this revision, JI$ T 9205 Hospital beds; esta

5、blished in 1983 and revised in 1994, has been revised referring to IEC 60601-2-38 : 1996 Medical electrical equipment-Part 2 : Particular requirements for the safety of electrically operated hospital beds and Amendment 1 : 1999. Attention is drawn to the possibility that some parts of this Standard

6、may conflict with a patent right, application for a patent after opening to the public, utility model right or application for registration of utility model after opening to the public which have technical properties. The relevant Minister and the Japanese Industrial Standards Committee are not resp

7、onsible for identifying the patent right, application for a patent after opening to the public, utility model right or application for registration of utility model after opening to the public which have the said technical properties. Date of Establishment: 1983-06-01 Date of Revision: 2001-01-20 Da

8、te of Public Notice in Official Gazette: 2001-01-22 Investigated by: Japanese Industrial Standards Committee Divisional Council on Medical and Safety JIS T 9205 : 2001, First English edition published in 2004-04 Translated and published by: Japanese Standards Association 4-1-24, Akasaka, Minato-ku,

9、Tokyo, 107-8440 JAPAN In the event of any doubts arising as to the contents, the original JIS is to be the final authority. O JSA 2004 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, inc

10、luding photocopying and microfilm, without permission in writing from the publisher. Printed in Japan PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 21:54:50 MDTNo r

11、eproduction or networking permitted without license from IHS -,-,- T 9205 : 2001 Contents Page 1 1 1 Introduction . 1 2 3 4 5 5.1 5.2 6 6.1 6.2 7 7.1 7.2 8 8.1 8.2 8.3 9 9.1 9.2 9.3 9.4 9.5 9.6 9.7 Scope Normative references Definitions Designation of each part Classification Body . Mattress Perform

12、ance Body and side rails . Mattress Construction . Body . Mattress Dimensions . Shape and dimensions of body Shape and dimensions of side rails Dimensions of mattress Material . Metallic material . Wood and woody material Urethane foam . Material of outer cloth Plastics and rubber . Paint . Other ma

13、terials 2 2 9 9 10 10 10 10 10 10 PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 21:54:50 MDTNo reproduction or networking permitted without license from IHS -,-,- T

14、 9205 : 2001 10 Test method 10.1 10.2 10.3 10.4 10.5 10.6 Static load test . Stability test of body . Horizontal load test Impact test Threshold test Coating test 10.6.1 10.6.2 Wooden part coating test . 10.7 Durability test of mattress 10.8 Load characteristic test of mattress Metallic part coating

15、 test . 11 Inspection 12 Designation of product . 12.1 Body . 12.2 Mattress 13 Marking . 13.1 Body . 13.2 Mattress 14 Instructions for use . 10 10 11 13 14 15 15 15 16 16 16 16 16 17 17 17 17 17 17 (ii) PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license wit

16、h JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 21:54:50 MDTNo reproduction or networking permitted without license from IHS -,-,- JAPANESE INDUSTRIAL STANDARD JIS T 9205 : 2001 Manually operated hospital gatch bed Introduction This Japanese Industrial Standard h

17、as been prepared referring to the first edition of IEC 60601-2-38 Medical electrical equipment-Part 2 : Particular requirements for the safety of electrically operated hospital beds, published in 1996 and Amendment 1 : 1999. However, this IEC Standard does not specify the manu- ally operated hospita

18、l gatch bed, so this Standard introduces only a part of specifi- cations for the strengtWperformance test, marking and instructions for use. 1 Scope This Standard specifies the manually operated hospital gatch bed (here- after referred to as “bed”) consists of the mattress and side rails which are c

19、ombined with the body of manually operated hospital gatch bed (hereafter referred to as “body”). This Standard is applicable to the flat floor type bed also, but excludes beds having a particular function or an electric drive (including an electric hydraulic drive). 2 Normative references The follow

20、ing standards contain provisions which, through reference in this Standard, constitute provisions of this Standard. The most recent editions of the standards (including amendments) indicated below shall be applied. JIS A 5905 JIS B 7502 JIS G 3101 JIS G 3123 JIS G 3131 JIS G 3141 JIS G 3350 JIS G 34

21、44 JIS G 3445 JIS G 3466 JIS G 3505 JIS G 3506 JIS G 3521 JIS G 3532 JIS K 5431 JIS K 5651 JIS K 6401 JIS L 1096 JIS S 1102 JIS Z 1522 Fib re boards Micrometer callipers Rolled steels for general structure Cold finished carbon and alloy steel bars Hot-rolled mild steel plates, sheets and strip Cold-

22、reduced carbon steel sheets and strip Light gauge steels for general structure Carbon steel tubes for general structural purposes Carbon steel tubes for machine structural purposes Carbon steel square pipes for general structural purposes Low carbon steel wire rods High carbon steel wire rods Hard d

23、rawn steel wires Low carbon steel wires Shellac varnish and bleached shellac varnish Aminoalkyd resin paint Flexible polyurethane foam for cushion Testing methods for woven fabrics Beds for domestic use Pressure sensitive adhesive cellophane tapes Japan Agricultural Standard (JAS) Regular plywood PR

24、OTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 21:54:50 MDTNo reproduction or networking permitted without license from IHS -,-,- 2 T 9205 : 2001 3 Definitions For the

25、 main terms used in this Standard, the following definitions manually operated hospital gatch bed The hospital bed having the function capable of adjusting the inclination angle of back section and leg section manu- ally. safe working load The load at which the bed can be safely used. single piece s

26、ide rails The side rails of which the length is not less than half the whole length of side frame of bed. segmented side rails The side rails of which the length is less than half the whole length of side frame of bed. apply: a) b) c) d) 4 Designation of each part The designation of each part shall

27、be as follows: Foot frame Foot board / Castor Driving handle a) Type K and Type O Head board 7 Segmented side rail - Mattress Driving handle Fret b) Type“ Fig. 1 Designation of each part PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IH

28、S Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 21:54:50 MDTNo reproduction or networking permitted without license from IHS -,-,- 3 T 9205 : 2001 I Type I Classification 5 Classification Abbreviation 5.1 classification of castor shall be in accordance with Table 2. Body The cla

29、ssification of body shall be in accordance with Table 1 and the The type in which the height of bottom is changeable and the frame of body is composed of head frame and foot frame. The type in which the height of bottom is changeable and the head board is removable partly or wholly, or movable up an

30、d down. Table 1 Classification and types of body O T 125 or over Type K The type in which the height of bottom is unchangeable II and the head frame and foot frame are fixed. L Type O Classification The type which is mainly composed of steel spring. The type which is mainly composed of urethane foam

31、 The type which is mainly composed of plastics fibre or other material. or other plastics foam material. Type T Abbreviation I II III Table 2 Classification of castor 5.2 Mattress The classification of mattress shall be in accordance with Table 3. Table 3 Classification and types of mattress Class 2

32、 6 Performance 6.1 Body and side rails a) Body and side rails shall be stable and strong when placed on a horizontal floor surface. A strange sound, creak and the like shall not be generated when used. Each part shall be finished well, and shall be free from dangerous projections or sharp corners, f

33、ine splits, flashes, burrs and the like. The surface of coating shall be smooth, and shall be free from cracks and no- ticeable mottles. b) c) PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie No

34、t for Resale, 03/15/2007 21:54:50 MDTNo reproduction or networking permitted without license from IHS -,-,- 4 T 9205 : 2001 Item Static load test Stability Lateral stability test test of body Longitudinal stability test d) For the metallic parts possible to produce rust, anti-corrosive treatment sha

35、ll be performed. The performances of body and side rails shall conform to the requirements in Table 4. Safe working load shall be at least 1700 N. This 1 700 N load is considered to be the sum of the following: - 1350 N (patient) - 200 N (mattress) - 150 N (accessories) Remarks : When tested, the lo

36、ad shall be distributed as shown in Fig. 5. e) f3 Performance Test subclause No abnormality found in any part. 10.1 Not fall down. 10.2 a) 10.2 b) Table 4 Performance of body and side rails Horizontal load test Stationary stability test Not move 10 mm or over. No abnormality found in any part. 10.2

37、c) 10.3 a) Head board (frame) Foot board (frame) Fret No abnormality found in any part. 10.3 b) Side rail 10.3 c) No abnormality found in any part, and the maximum deviation shall be not more than 80 mm at the central part of the upper end. Impact test I Threshold test I No abnormality found in any

38、part. j 10.5 I No abnormality found in any part. 10.4 Coating test Metallic Part I Adhesion property points. The peeling of coating shall be within five 10.6.1 a) Anti-corrosion property Swell or rust shall not be found at the outer part of 3 mm apart from the both ends of flaw. 10.6.1 b) Thickness

39、of Not less than 20 pm at visible part P). coating I 6.2 Mattress I 10.6.1 c) a) The mattress shall be able to bend, fitting to the ups and downs of bottom. Wooden part PROTECTED BY COPYRIGHT The peeling of coating shall be within five points. 10.6.2 Copyright Japanese Standards Association Provided

40、 by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 21:54:50 MDTNo reproduction or networking permitted without license from IHS -,-,- 5 T 9205 : 2001 Item Durability The sewing of outer cloth shall be of high quality, and shall be free from

41、defects such as distortions, wrinkles, slackness, frays, skipped stitches, yarn cuts, cuts, fissures and the like. The outer cloth shall have sufficient strength and shall be free from the possi- bility of fading, discoloration and the like, and stains, dirts, etc. shall not be found. The creak, str

42、ange sound, etc. detrimental to use shall not be generated. The mixing of foreign matters and unpleasant smell shall not be allowed. The performance of mattress shall conform to the requirements in Table 5. Table 5 Performance of mattress Performance Test subclause Each permanent set, di, dz, d3 sha

43、ll be not more than 30 mm. 1 0 . 7 Load I The outer cloth shall be free from slip-outs, frays, breaks, etc. I The breaks and disconnections of spring shall not be found. Deflection increase amount Class 1 DI I 30 mm I The movement, falling-in, etc. of padding shall not be found. I I I character- ist

44、ic Class 3 10.8 7 Construction 7.1 Body a) At least two castors out of all shall have locking devices. And the interchange- ability shall be taken into consideration. For the bed of Type T, the head board and foot board shall be considered so that the shock-absorbing bumper against wall surface is e

45、quipped. It shall be considered so that an IV stand, a harn bag, a dranage bag and the like can be equipped. The mechanism shall be constructed so that the inclination angle between back section and leg section can be adjusted (excluding the flat floor type bed). b) c) d) 7.2 The mattress shall be c

46、onstructed so as to be bent fitting to the ups and downs of bottom and to have appropriate elasticity, and the surface shall be covered with cloth and the like. Mattress 8 Dimensions 8.1 Shape and dimensions of body The shape and dimensions of body shall be in accordance with Fig. 2, Fig. 3 and Tabl

47、e 6. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 21:54:50 MDTNo reproduction or networking permitted without license from IHS -,-,- 6 T 9205 : 2001 I 1 Fig. 2 Sha

48、pe of body Unit: mm Lateral direction - 1 100 or over to and excl. 1 200 Under 1 100 I I I I Fig. 3 External shape of body PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 21:54:50 MDTNo reproduction or networking permitted without license from IHS -,-,- 7 T 9205 : 2001 Dimensions Hole for fixing side rails

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