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GB/T 31181-2014: Prosthetics Testing of ankle-foot devices and foot units -- Requirements and test methods
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Prosthetics Testing of ankle-foot devices and foot units -- Requirements and test methods
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GB/T 31181-2014
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Basic data | Standard ID | GB/T 31181-2014 (GB/T31181-2014) | | Description (Translated English) | Prosthetics Testing of ankle-foot devices and foot units -- Requirements and test methods | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 80,878 | | Date of Issue | 9/3/2014 | | Date of Implementation | 1/1/2015 | | Quoted Standard | ISO 8549-1; ISO 10328-2006; ISO 22523-2006 | | Adopted Standard | ISO 22675-2006, TDT | | Regulation (derived from) | People's Republic of China Announcement of Newly Approved National Standards No. 21 of 2014 | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This Standard specifies the lower limb prosthetic ankle-foot devices and foot assembly dynamic test, the static test and verification test procedures ultimate static strength tests. Dynamic and static test procedure specified in this standard, the test lo | GB/T 31181-2014: Prosthetics Testing of ankle-foot devices and foot units -- Requirements and test methods
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Prosthetics Testing of ankle-foot devices and foot units. Requirements and test methods
ICS 11.040.40
C35
National Standards of People's Republic of China
Prosthetic ankle-foot devices and foot assembly
Requirements and test methods
(ISO 22675.2006, IDT)
Issued on. 2014-09-03
2015-01-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 Test Force names and symbols 2
5 strength and performance requirements and conditions of use 2
6 coordinate system and the test configuration 3
7 load test conditions and test loading grade 6
8 Numerical test force, size and period of 7
9 Compliance 14
10 16 test samples
Responsibilities 11 Test preparation 19
12 20 Test submission document
13 Equipment 21
14 accuracy 30
15 31 Test principle
16 test program 32
17 testing laboratories (inspection department) Workbook 46
18 46 Test Report
19 Classification and nomenclature 47
20 Label 47
Data refer to Appendix A (informative) The standard test load and test conditions specified load level 50
Annex B (informative) static ultimate strength test alternative Application Guide 56
Test the load levels P6 Application Guide Appendix C (informative) imposed additional 57
Annex D (informative) testing laboratories (inspection department) workbook summary records 59
Appendix E (normative) technical report ISO /T R22676 information 64
Appendix F (Informative Appendix) ISO /T R16142 medical device safety and performance of the basic principles of reference 73
References 74
Referring to FIG. 1 has parameters of the coordinate system 4
Figure 2 prosthetic foot vertical axis (see 6.7.2) and the center of the ankle joint is equivalent to CA (see 6.7.3) Determination of 6
Figure 3 illustrates the establishment of reference points listed in Table dynamic test loading curve Threshold 1012
4 foot test samples with top loading point PT specific configuration illustrated 18
5 13.4.1 and 13.4.2 installed test equipment schematic of the test sample 27
Figure 6 Determination of the standard dynamic test loading conditions of the time synchronization function test force Fc (t) and the tilt angle γ (t) curve 29
FIG. 7 as the prosthetic foot loading platform tilt angle γ (t) function test load class P5 test force Fc (γ) 30
8 static load test program test preparation [see 16.1.1a)] 34
Static verification test prescribed flowchart of FIG 16.2.1 37
10 16.3.1 flowchart 41 static ultimate strength test
Dynamic test specified in the flowchart of FIG 16.4.1 (Continued Figure 12) 44
12 is a flowchart dynamic test specified in 16.4.1 (Continued Fig. 11) 45
13 label layout for the general rule 48
14 label layout style layout 49
Different component shown in Figure A.1 loading force 54
Figure A.2 top loading point PT position with the prosthetic foot length change diagram (see A.2.2.3) 55
Figure E.1 f-axis position of the prosthetic foot loading platform tilting axis TA of heel and toe of the prosthetic foot from the ground instantly raise the height E
Effect 66
Figure E.2 impact prosthetic foot loading platform tilting axis TA u-axis position of the toes off the ground instantaneous displacement Δf false front and rear legs 67
Figure E.3 impact test samples before and after the displacement Δf top loading point PT angular displacement around the icon 68
Figure E.4 top load point shift compensation PT prosthetic foot loading platform with the position of the tilting axis TA prosthetic foot length L may change
Can illustration 70
Figure E.5 prosthetic foot loading platform tilting axis TA compromise fixed offset uTA, C shown on the false front and rear legs of the displacement Δf
[See E.3.4.2c) 2)] 71
Table 1 Test force names and symbols 2
Table 2 strength classification and performance requirements and test verification methods 3
Table 3 Test Force and related reference 7
Table 4 and Annex termination validated arm rigid prosthetic foot model design and adjustment of test apparatus for simulating foot ankle or foot assembly
Specify prosthetic foot length L of the bottom offsets fB1, L (heel) and fB2, L (forefoot) values \u200b\u200brelated to (see 13.2.2) 8
Table 5 Test load rating P5, P4, P3 terminal fitting verification test force test (see 13.2.1) 8
Table 6 test sample and the total length of the terminal fitting length 9
Table 7 based on the specified top prosthetic foot length L all levels of the test load and load point PT prosthetic foot loading platform tilting axis TA
Coordinates 10
Table 8 at an angle of 10 all test load rating at a specific tilt position prosthetic foot toes outward position and the prosthetic foot loading platform
Table 9 Test cycles under load rating P5, P4 and P3 test force all tests and dynamic tests specified (see 16.2,16.3
And 16.4) 11
10 Table 3 dynamic load test threshold curve 12
Tilt 30ms time increment guidance table 11 shown in FIG. 6 loaded in the angle γ (t) and the test force Fc (t) values \u200b\u200b13
Table 12 statement of compliance tests and test samples of the standard required for the number 16
Termination Table 13 optional accessory specially designed 22
Referring to Table A.1 force FR1x and size FR2x 52
Table C.1 test at test force loading level P6 terminal fitting verification test (see 13.2.2.1) 57
Table predetermined number of cycles C.2 Test load test force all grades P6 tests and dynamic tests (see 16.2,16.3 and 16.4) 58
Table of Contents E.1 ISO /T R22676 and the corresponding provisions of the standard list of 64
Possibility of table E.2 top load point shift compensation PT prosthetic foot loading platform tilting axis TA position changes with the prosthetic foot length L 72
Table F.1 This standard R16142 basic principles and ISO /T table 73
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard uses the translation method identical with ISO 22675.2006 "prosthetic ankle-foot devices and foot assembly requirements and test methods."
Correspondence between the consistency of the standards of international documents and normative references of the following documents.
--- GB/T 14191.1-2009 Prosthetics and orthotics academic language - Part 1. external limb prostheses and external orthoses group
The term (ISO 8549-1. 1989, IDT).
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
The standard proposed by the People's Republic of China Ministry of Civil Affairs.
This standard by the national rehabilitation and special equipment Standardization Technical Committee on Persons with Disabilities (SAC/TC148) centralized.
This standard was drafted. national rehabilitation aids research center.
The main drafters of this standard. Ma Feng collar, Liu Junling, Zhang Fang.
Introduction
This standard gives the ISO 10328.2006 alternative ankle-foot device specified in 17.2 and foot assembly of structural surveys,
ISO 10328.2006 test method specified in 17.2 less than the following.
a) before the heel and forefoot test force action line and ISO 10328.2006 16.2 (static test) and 16.3 (dynamic test) prescribed
Master structure test test test force loading conditions Ⅰ and Ⅱ line of action is inconsistent;
During b) palm loaded before loading the dynamic test the heel and foot, respectively, the instantaneous maximum load and load size sub-process
actual;
c) while the front heel and forefoot loading from different angles, resulting in cyclical phenomenon "false step" that appear in the dynamic test and the like.
Test methods specified in this standard has the following characteristics.
a) dynamic test, can simulate heel to toe off the ground to support the entire travel period and the strength, durability and service life performance is
Seeking to verify the actual load conditions, which for various types of ankle foot only in the actual loading conditions in order to play its special properties
Performance evaluation apparatus and foot assembly, this feature is very important;
b) the static test, and the line of action to produce dynamic tests before the maximum heel and forefoot loading moment consistent test force heels
And forefoot test force.
About the relationship between the two, important to note that the test equipment specified in this standard test ankle-foot devices and foot assembly is not complicated,
ISO 10328 is similar to the corresponding sub-structure test equipment inspection requirements. Outside, these two basic components of similar test equipment,
After the modification may be used.
Finally, to be noted that the basic concept of the test procedure specified in this standard can be used in the future for about ankle-foot devices and foot assembly
Specific performance evaluation.
In order to ensure the continuity of ankle-foot devices and foot assembly inspection, a transition period will be set aside. During the transition period these two test methods are
Efficiency, control by ISO 10328.2006 test method specified in 17.2, check this standard test methods. According to the transition period
ISO 10328.2006 and the present time standard assessment system adjustments. Through systematic assessment of these two criteria, this show is expected to draw
Some other research results of the test method standards for suitability.
Note. The test loading conditions and test the load levels and test equipment design guidelines, see separate document "Technical Report" (see References).
Prosthetic ankle-foot devices and foot assembly
Requirements and test methods
1 Scope
Important. This standard applies to ISO 22523.2006 (see Note 1) 4.4 conformity assessment specified strength requirements ankle-foot devices and foot assembly
set. The market has passed the relevant tests of ISO 10328 test, and demonstrate compliance with EN12523. 4.4 specified strength requirements of fake 1999
Limb ankle-foot devices and foot components do not need to re-examination in accordance with this standard.
Warning. This standard does not apply to guidelines issued as the choice of the lower limb prosthesis prescription ankle-foot device or foot assembly. Regardless of any warning
Behavior may pose a security risk to the amputee.
This standard specifies the lower limb prosthetic ankle-foot devices and foot assembly dynamic testing, static verification and static ultimate strength test test test
program.
Dynamic and static test procedures specified in this standard, the test applied for each submission of ankle-foot device or foot assembly unified sample applied
Load conditions characteristic curve is represented by a standardized format and load movement curve.
Ankle-foot devices and foot assembly inspection of each sample in the load can be free to play their own performance.
Note 1. ISO 22523 (previously EN12523) describes the "European Medical Devices Guideline 93/42/EEC" groups listed in Appendix I applies to the prosthetics and orthotics
This requirement.
Note 2. The static test procedure specified in this standard produced the heel and forefoot test force action line, close to the main structure test sample is determined as specified in ISO 10328
Sagittal line of action of load test loading conditions Ⅰ and Ⅱ, and does not change the ISO 10328 provisions ankle-foot devices and foot and heel components of structural tests
Foot forefoot loading platform angle.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
ISO 8549-1 prosthetics and orthotics - Vocabulary - Part 1. External prostheses and orthopedic devices external general term
(Prostheticsandorthotics-Vocabulary-Part 1. Generaltermsforexternallimbprosthesesand
externalorthoses)
ISO 10328.2006 Prosthetics - Structural testing of lower limb prostheses - Requirements and test methods (Prosthetics-Structuraltestingof
lowerlimbprostheses-Requirementsandtestmethods)
ISO 22523.2006 Prosthetics and orthotics - Requirements and test methods (Externallimbprosthesesandexternalortho-
ses-Requirementsandtestmethods)
3 Terms and Definitions
As defined in ISO 8549-1 and the following terms and definitions apply to this document.
3.1
Verify strength proofstrength
Representative occasional harsh circumstances under ankle-foot device or foot can still perform its intended function components can withstand a static load.
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