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1、JIS JAPANESE INDUSTRIAL STANDARD Translated and Published by Japanese Standards Association JIS T 0111-8:1997 (IS0 10328-8 : 1996) (Reaffirmed : 2003) Prosthetics - Structural testing of lower-limb prostheses - Part 8 : Test report ICs 11. 040.40 Descriptors : artificial limbs, artificial organs, le
2、gs, mechanical testing, strength of Reference number JIS T 0111-8 1997 (E materials, medical equipment, samples PROTECTED BY COPYRIGHT 22s Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 00
3、:55:06 MDTNo reproduction or networking permitted without license from IHS -,-,- T 0111-8 : 1997 (IS0 10328-8 : 1996) Foreword This translation has been made based on the original Japanese Industrial Standard established by the Minister of International Trade and Industry, through deliberations at t
4、he Japanese Industrial Standards Committee in accordance with the Industrial Standardization Law: JIS T O111 consists of the following 8 parts under the general title Prosthetics-Structural testing of lo wer-limb prostheses - Part : Test codimations - Part 2 : Test samples - Part 3 :Principal struct
5、ural tests - Part 4 : Loading parameters of principal structural tests - Part 5 : Supplementary structural tests - Part 6 : Loading parameters of supplementary structural tests - Part 7 : Test submission document - Part 8 : Test report Date of Establishment: 1997-07-20 Date of ReaEirmation: 2003-05-
6、20 Date of Public Notice in Official Gazette: Investigated by: Japanese Industrial Standards Committee Divisional Council on Medical and Safety 2003-05-20 JIC T 0111-8 : 1997, First English edition published in 2004-08 Translated and published by: Japanese Standards Association 4-1-24, Akasaka, Mina
7、to-ku, 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 AU rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanica
8、l, including photocopying and microfilm, without permission in writing from the publisher. Printed in Japan M the type of sample in accordance with, 4.1, 4.2 or 4.3 of JIS T 0111-2. In special cases refer to the test submission document (see JIS T 0111-7); the most adverse prosthetic assembly possib
9、le in accordance with 4.6.3 of JIS T 0111-3 specified in the test submission document depending on type of test sample -see b); the load application levers used in accordance with 8.4 of JIS T 0111-2; the alignment in accordance with clause 7 and 8.5 of JIS T 0111-2. 5.2 For static failure and cycli
10、c test samples Any substitution of flexible parts with rigid parts in accordance with 6.3 and 6.4 of JIS T 0111-2 as well as 6.2.8 andlor 7.2.2 of JIS T 0111-3, 7.4.8 and/or 7.5.1.2 of JIS T 0111-5. 6 be included in the test report. a) The particular tests carried out in accordance with the relevant
11、 clauses of JIS T 0111-3 andlor JIS T 0111-5. In special cases reference to the test submission document will be necessary; Records required for all tests The following information for each test sample shall PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under licens
12、e with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 00:55:06 MDTNo reproduction or networking permitted without license from IHS -,-,- 4 T 0111-8 1997 (Is0 10328-8 : 1996) b) the particular dimensions and forces applied during the tests in accordance with the re
13、levant clauses of JIS T 0111-4 and/or JIS T 0111-6. In special cases reference to the test submission document will be necessary; c) proof test of attachments (if required) in accordance with 5.4 of JIS T 0111-3; d) accuracy of test equipment and individual measurements in accordance with clause 9 o
14、f JIS T 0111-3. 7 for each test sample shall be included in the test report. Records required for results of principal structural tests The following information 7.1 a) Measurements of lengths and calculation of deformation in accordance with 5.4.2.4 through 5.4.2.7, 6.1.5, 6.1.8, and 6.1.9 of JIS T
15、 0111-3; b) examinationinspection of function in accordance with 6.1.11 of JIS T 0111-3; c) load at, and nature of, any failure in accordance with 6.1.12 of JIS T 0111-3. For results of all static proof tests 7.2 a) Measurement of effective lever arms in accordance with 6.2.5 of JIS T 0111-3; b) the
16、 ultimate test force E, in accordance with 6.2.6 and 6.2.7 of JIS T 0111-3; c) at the request of the manufacturer/submitter, results of the continuation of test until failure actually occurs in accordance with the note following 6.2.7 of JIS T 0111-3 and with 6.2 of J I S T 0111-7; d) the mode of fa
17、ilure in accordance with 3.1, 3.2 and 6.2.9 of JIS T 0111-3. For results of all static failure tests 7.3 a) All switch-off occurrences in accordance with 7.2.11 of JIS T 0111-3; b) replacement of normal service parts in accordance with 7-22 of JIS T 0111-3; c) measurements of lengths in accordance w
18、ith 7.2.6, 7.2.7, and 7.2.10 of JIS T 0111-3; d) the endurance in accordance with 72-13 of JIS T 0111-3; e) at the request of the manufacturer/submitter, the presence and nature of any cracks in accordance with 7.1.5 of JIS T 0111-3 and 6.3 of JIS T 0111-7; results of the final static test to proof
19、load level in accordance with 7.1.5 of JIS T 0111-3; failures of components adjacent to rigid substitutes of flexible parts in accordance with 7.1.6 of JIS T 0111-3; h) inspection results of nature of any failure in accordance with 7.2.14 of JIS T 0111-3. For results of all cyclic tests f) g) PTOTEC
20、TED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 00:55:06 MDTNo reproduction or networking permitted without license from IHS -,-,- 8 information for each test sample shall
21、be included in the test report. 8.1 Results of all tests in torsion For all torsion tests, records in accordance with 4.3.11 of JIS T 0111-5. 8.2 a) Records required for results of supplementary structural tests The following Results of tests on ankle-foot devices For results of all tests on ankle-f
22、oot devices, records limited to feet and their connections in accordance with 5.1 of JIS T 0111-5. b) For results of static proof tests on ankle-foot devices, results in accordance with 5.4.1.10 of JIS T 0111-5. For results of static failure tests on ankle-foot devices, results in accordance with 5.
23、4.2.3, 5.4.2.4, 5.4.2.6, 5.4.2.7, and 5.4.2.9 of JIS T 0111-5. d) For results of cyclic tests on ankle-foot devices, results in accordance with 5.4.3.6, 5.4.3.7, 5.4.3.8, and 5.4.3.9 of JIS T 0111-5. Results of a l l tests on knee flexion stops c) 8.3 For all results of tests of knee flexion stops,
24、the load at and the mode of failure in accordance with 6.3.4 of JIS T 0111-5. 8.4 a) For results of static proof tests on knee locks Results of tests on knee locks i) Measurements of lengths and calculations of deformation in accordance with 7.3.5, 7.3.8, and 7.3.9 of JIS T 0111-5. Results in accord
25、ance with 7.3.10 and 7.3.12 of JIS T 0111-5. 2) b) For results of static failure tests on knee locks i) 2) The ultimate test force F, in accordance with 7.4.7 of JIS T 0111-5. At the request of the manufacturerhbmitter, results of the continuation of test until failure actually occurs in accordance
26、with the note following 7.4.8 of JIS T 0111-5, and with 6.2 of JIS T 0111-7, The mode of failure in accordance with 7.4.10 of JIS T 0111-5. 3) c) For results of cyclic tests on knee locks 1) 2) 3) Measurements of lengths in accordance with 7.5.1.7 and 7.5.1.11 of JIS T 0111-5. The endurance in accor
27、dance with 7.5.1.12 of JIS T 0111-5. At the request of the manufacturersubmitter, the presence and nature of any cracks in accordance with 7.5.1.13 of JIS T 0111-5 and 6.3 of JIS T 0111-7. 4) Failures of components adjacent to rigid substitutes of flexible parts in accordance with 7.5.1.15 of JIS T
28、0111-5. The nature of any failure in accordance with 7.5.1.16 of JIS T 0111-5. 5) PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 00:55:06 MDTNo reproduction or netwo
29、rking permitted without license from IHS -,-,- 6 T 0111-8 : 1997 (Is0 10328-8 : 1996) Annex A (informative) The following sample data sheets show the preferred format of the test report. Their layout allows the provision of all information concerning general requirements, as well as records required
30、 for test samples, tests and test results, as specified in clauses 4 to 8 of JIS T 0111-8. PTOTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 00:55:06 MDTNo reproduction
31、 or networking permitted without license from IHS -,-,- 7 1997 (IS0 10328-8 : 1996) T 0111-8 Specification according to 5-4-22 of Part 3 JIS T 0111-8 Prosthetics -Structural testing of lower-limb prostheses Test report -Proof test o f attachments Document identification : (see 4.4) Table Al Individu
32、al lever length Prepared by : (see 4.3) Test laboratory/facility : Address : Lengths and Measured deformations value Test load level : (see 4.4.2 of Part 3) A Specified Reference in clauses of limit Part 3 Proof test for attachments : (see 5.4 of Part 3) Test results : (see clause 6 and 7.1) L i L 2
33、 L 3 D i Length of load application levers 5.4.2.4 5 . 4 . 2 . 5 5.4.2.6 2 5.4.2.7, 5.4.3 Bottom load application lever Top load application lever Tel. No. FaxNo. : 120 120 I D 2 I 1 0.5 I 5.4.2.7, 5.4.3 1 Date Year Month : Day : Remarks Signature : Date of report : (see 4.6) (see 4.7) I See Part 3
34、and Part 8. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 00:55:06 MDTNo reproduction or networking permitted without license from IHS -,-,- 8 T 0111-8 1997 (IS0 10
35、328-8 : 1996) JIS T O 1 11-8 Prosthetics -Structural testing o f lower-limb prostheses Test report -Principal structural tests -Static proof test Document identification : (see 4.4) Table A.2- 1 Prepared by : (see 4.3) Test laboratory/facility : Tel. No : Address : Fax No : Identification of test su
36、bmission document and date of submissionldispatch : Test sample(s) submitted by : (see 4.5) Submitter Address : Test load level : (see 4.4.2 of Part 3) Test sample : (see clause 5) Tel. No. : Fax No. : A See Part 3 and Part 8. PTOTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided
37、by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 00:55:06 MDTNo reproduction or networking permitted without license from IHS -,-,- JIS T O 1 11-8 Prosthetics -Structural testing of lower-limb prostheses Test report -Principal structural te
38、sts -Static proof test Document identification (see 4.4) Table A.2-2 Parts used OTop load application lever Extension piece Connection piece/adaptor Knee unit Connection piece/adap tor Extension piece QAdap tor/ankle unit Bottom load application lever : or foot (see note 211 IdentificatiodType of te
39、st sample (see clause 4 of Part 2) Figure A.1 Test assembly Notes 1 AU pieces listed in figure A.l may be part of the sample under test except the load application levers. 2 Where a foot or a structure including a foot is part of the sample under test or used instead of the bottom load application l
40、ever, see 5 . 2 of Part 2 for : Selected foot size : Actual combined bottom offset : Remarks : See Part 2 and Part 8. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007
41、00:55:06 MDTNo reproduction or networking permitted without license from IHS -,-,- 10 T 0111-8 : 1997 (IS0 10328-8 : 1996) Test loading condition I I I JIS T O 1 11-8 Prosthetics -Structural testing o f lower-limb prostheses Test report -Principal structural tests -Static proof test Document identif
42、ication : (see 4.4) Table A.2-3 Actual settling Specification Actual proof test Specification test force Fset according to table force E, according to 2 of Part 4 and table 6 of Part 4 Part 3 and Part 3 Sample Sample Subclause Sample Sample Subclause 1 2 of Part 3 : 1 2 of Part 3 : 6.1.3) 6.1.6*) 6.
43、1.3) 6.1.6) Test results : (see clause 6 and 7.1) Test loading condition Test loading condition Effective lever arm lengths and deformation LA Jk L4 L A Jk L h“ Dimensions in millimetres Test sample 1 I Test sample 2 I Reference subclause in Part 3 I 6.1.5 6.1.5 6-15 6.1.8 6.1.8 6.1.8 6.1.9 I Note)
44、Limited to fis 15 mm according to 6.1.10 of Part 3. Remarks : See Part 2, Part 3, Part 4 and Part 8. PTOTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 00:55:06 MDTNo re
45、production or networking permitted without license from IHS -,-,- 11 1997 (IS0 10328-8 : 1996) T 0111-8 Test loading Sample functions safely conditions (see 6.1.11 of Part 3) Yes No I o U I I O 17 I O o I I 17 o JIS T O 1 11-8 Prosthetics -Structural testing of lower-limb prostheses Test report -Pri
46、ncipal structural tests -Static proof test locument identification (see 4.4 Table A2-4 Load at, and nature of, failure (see 6 . 1 . 1 2 in Part 3) Sample 1 2 Remarks : The specimen submitted for this test satisfies the relevant requirements of load level A of JIS T O111 Yes0 No17 Signature : (see 4.
47、6) Date of report : (see 4.7) - See Part 3 and Part 8. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 00:55:06 MDTNo reproduction or networking permitted without lic
48、ense from IHS -,-,- JIS T O 1 11-8 Prosthetics -Structural testing of lower-limb prostheses Test report -Principal structural tests -Static failure test Document identifleation : (see 4.4) Table k 3 - 1 Prepared by : (see 4.3) Test labor a tory/facility Address : Tel. No. : FaxNo. : Identification of test submission document and date of submissioddispatch : Test sample(s) submitted by : (see 4.5) Submitter : Address : Test load level : (see 4.4.2