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GB 14723-2008: Modular units of the lower limb prosthesis
Status: Valid GB 14723: Evolution and historical versions
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| GB 14723-2008 | English | 329 |
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Modular units of the lower limb prosthesis
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GB 14723-2008
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| GB 14723-1993 | English | 439 |
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Modular units of the lower limb prosthesis
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GB 14723-1993
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PDF similar to GB 14723-2008
Basic data | Standard ID | GB 14723-2008 (GB14723-2008) | | Description (Translated English) | Modular units of the lower limb prosthesis | | Sector / Industry | National Standard | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 14,184 | | Date of Issue | 2008-09-19 | | Date of Implementation | 2009-03-01 | | Older Standard (superseded by this standard) | GB 14723-1993 | | Quoted Standard | GB/T 191; GB/T 1931; GB/T 3293; GB/T 9174; GB/T 10000; GB/T 14191; GB/T 18375 | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 17 of 2008 (No. 130 overall) | | 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 Chinese standard specifies the lower limb amputees using common parts of lower limb prosthesis model, size, shape, technical requirements, test methods and inspection rules. This standard applies to a variety of lower limb prosthesis common parts, including prosthetic foot, ankle, knee, hip, fittings, decoration pieces. | GB 14723-2008: Modular units of the lower limb prosthesis---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Modular units of the lower limb prosthesis
ICS 11.040.40
C45
National Standards of People's Republic of China
Replacing GB 14723-1993
Commonality lower limb prosthesis
Posted 2008-09-19
2009-03-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Table of Contents
Introduction Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 Model 1
5 size, shape 3
6 Technical requirements 5
7 Inspection Method 6
8 8 Inspection Rules
9 Sampling Rule 8
10 signs, packaging, transportation and storage 8
Foreword
Chapter 6 of this standard are mandatory, others are recommended standards.
This standard replaces GB 14723-1993 "lower limb prosthetic component commonality."
Compared to this standard and GB 14723-1993 "lower limb prosthesis common parts", the main differences are.
a) an increase in lower limb prosthesis common parts in emerging new materials and new products, such as energy storage prosthetic foot, knee intelligence, silicon
(Condensate) plastic inner liner, carbon fiber receiving chamber and so on;
b) In this standard, structural strength test universal prosthetic member, cited GB/T 18375-2004 "prosthetic lower limb prosthesis
Structural testing ", GB/T 18375-2004 identical with ISO 10328;
c) The minimum knee flexion angle bone formula was revised, the original 65 °, this standard is 70 °.
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, orthopedic center in Fujian, Beijing orthopedic technology center, Shandong Province prosthetic straightening
Shaped rehabilitation center.
The main drafters of this standard. Yan peace, Yangcheng Rui, ROCKETS, Wuguo Shi, Diao built.
This standard was first released in 1993.
This standard is the first revision.
Commonality lower limb prosthesis
1 Scope
This standard specifies the lower limb prosthetic lower limb amputees use common parts of the model, size, shape, technical requirements, testing methods and
rule.
This standard applies to a variety of common parts of the lower limb prosthesis includes prosthetic foot, ankle, knee, hip, connectors, and other decorative pieces.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB/T 191 Packaging - Pictorial signs
GB/T 1931 Method for determination of moisture content of wood
GB/T 3293 Chinese shoe and shoe series
GB/T 9174 General cargo transport packaging technology
GB/T 10000 Chinese adult body size
GB/T 14191 prosthetics and orthotics term
GB/T 18375 (all parts) Structural testing of lower - limb prostheses
3 Terms and Definitions
GB/T 14191 and established in the following terms and definitions apply to this standard.
3.1
For connection between the prosthetic components, fixed components, some of which have adjustment.
3.2
It is having a characteristic parameter while walking through computer processing, and support of, or adaptive swing phase control through the sensor sampling amputees
Knee system functions.
3.3
After knee flexion, the thigh and posterior leg angles formed.
4 Model
4.1 lower limb prosthesis component commonality model by the product type code, part code, structure type code, design and modification of code components. Its composition
The following form.
product type code
member code
Structure type code
design and code modifications
a) Product Type Code. use "under false zero" in the name Pinyin first in capital letters "XJL" represents lower limb prosthetic components;
b) Part code. member body parts classification by using Arabic numerals, as shown in Table 1.
Table 1
Code 123456789
Part fake ankle tie-lining Hip garnish suspension device receiving cavity of the knee
c) type code structure. structural type English name represented a significant English letters, as shown in Table 2.
Table 2
Member structure type code
Prosthetic foot
SACH foot N
Uniaxial foot S
Swivel Feet P
Adjustable feet with high H
Storage foot N
Other E
ankle joint
Housing type C
Static ankle N
Single-axis S
Universal ankle P
Other E
Connector
Housing type C
Component T
Rotating disk (cross-legged device) R
Buffer (axial, torsional) B
Other E
Knee
Hinged J
Housing type C
Single-axis S
Multi-axis P
Intelligent I
Other E
Member structure type code
Inner liner
Inner fabric liner C
Inner foam liner P
Inner liner gel G
Silicone inner liner S
Other E
hip joint
Hinged J
Single-axis S
Multi-axis P
Other E
Decorative pieces
Decoration Soft Case F
Decorative shell C
Decorative socks H
Other E
Suspension device
A prosthetic leg suspension device
Prosthetic leg suspension device B
Other E
Receiving chamber
L leather production
Timber production W
Fiber reinforced resin which R
Plastic plate production T
Full carbon fiber production C
Other materials E
d) design and retrofit code. design code with two Arabic numerals denote design sequence (when the order digit, ten up
zero). Modification of code with capital letters A, B, C respectively for modification order.
4.2 Example
Example 1. XJL4C01 represents 01 housing type knee.
Example 2. XJL2P03A represents the first redesign of the 03 universal ankle.
5 size, shape,
5.1 size and shape of the prosthetic components shall be designed so that the finished shape and prosthetic limbs replaced remained the same.
5.2 bodied size, shape and methods of measurement of the lower extremities with reference to the provisions of GB/T 10000 of.
5.3 prosthetic foot size and shape of the reference GB/T 3293 regulations.
5.3.1 feet long range L (see FIG. 1) is selected to 130mm ~ 300mm, 10mm apart divided by 18 models, as shown in Table 4.
5.3.2 heel height H (see FIG. 1) Refer to Table 5 values specified selection.
5.3.3 Methods of measurement with high H's.
Note. H for the heel height, x is the gauge block.
Figure 1
According to the amount of protrusion gauge block 1 and specified in Table 3, so that the surface is placed fake ankle design position. (Example. SACH ankle surface in a horizontal position
Home, moving ankle top ankle design drawings specified angle) with the value of H is high.
Table 3 millimeters
Foot length ≤160 170 ~ 190 200 ~ 210 220 ~ 230 240 ~ 260 270 ~ 280 ≥290
Block the regulation reach 15,202,530,354,045
Table 4 millimeters
Foot length L 130 140 150 160 170 180 190 200 210 220 230 240 250 260 270 280 290 300
Table 5 millimeters
With high H 0,5,10,15,20,25,30,35
5.4 ankle member shape and size should match the prosthetic foot, ankle style housing in four models, corresponding to the external dimensions and foot-long series
Dimensions are shown in Table 6.
Table 6 millimeters
Prosthetic foot 190 feet long and 200 210 to 220 230 to 250 260 to 300
Ankle-style housing
Series 1234
Dimensions
Length × width
78 × 42 88 × 48 98 × 54 106 × 58
5.5 Connecting tube outer diameter selected 34-0.01-0.05 mm, 30-0.01-0.05 mm, 25-0.01-0.05 mm, 22-0.01 -0.05 mm, with holes to allow its tolerance
34 + 0.05 0 mm, 30 + 0.05 0 mm, 25 + 0.05 0 mm, 22 + 0.05 0 mm.
Width B 5.6 housing type knee (see Figure 2) consists of four models, sizes as shown in Table 7.
Figure 2
Table 7 millimeters
Series 1234
Knee width B 90 95 100 105
5.7 decorative soft case should be made of the healthy limb phase approximation.
5.7.1 Figure 3 and Table 8 provides a finished shape and size of decorative soft sleeve.
Figure 3
Table 8 millimeters
Code
Calf decorated decoration thigh Soft Case Soft Case
123456123456
L 530 570 610 610 610 610 760 840 890 890 990 1040
A 330 330 360 380 380 430 440 460 480 510 560 570
B - - - - - - 370 370 380 410 430 490
C - - - - - - 330 360 360 370 410 450
D 300 320 330 360 380 380 300 330 360 380 410 450
E 200 200 230 230 240 250 200 200 230 230 250 280
Note. The large, soft calf decorative finished sets are divided left and right.
5.7.2 provide semi-finished products according to the shape and size of decorative soft sleeve shown in Figure 4 and Table 9 below.
Figure 4
Table 9 millimeters
Code calf decorative soft case (semi-finished)
Decorative thigh soft case (semi-finished)
L 500 900 900
A 630 680 680
C - 380 430
D - 380 400
E 450 480 480
Note. Decorative thigh soft case (semi-finished) divided left and right.
5.8 connector housing member and a decorative shell shape and size should be approximated with the healthy limb.
6 Technical Requirements
6.1 General Requirements
Lower limb prosthetic components should be manufactured in accordance with design drawings and technical documents.
6.2 ankle member
6.2.1 ankle member to approximate the shape of a human foot, with the contralateral shoe to wear the same shoes.
6.2.2 In the walk when the prosthetic foot contact with the ground, you should have the ability to absorb shock and sufficient resilience. 7.1.1 and 7.1.2
Determination, ankle plantar flexion member, the deformation of dorsiflexion to comply with Table 10, and plantar flexion deformation size should be divided into soft (labeled S),
Hard (labeled H) two specifications.
6.2.3 according to measurement method 7.1.3, universal ankle should be able to achieve internal and external rotation of each of the above 3 ° range of motion.
6.2.4 Determination by 7.1.4, should be able to achieve universal ankle inside, each 5 ° valgus range above activities.
6.2.5 After assembling the outer prosthetic foot forward direction of rotation and the center line 5 ° ~ 6 °.
Table 10 millimeters
Plantar flexion deformation
Hard (H) 6 ~ 15
Soft (S) 16 ~ 22
Dorsiflexion deformation amount 20 to 40
6.3 parts of knee
6.3.1 should have the regulatory function of the line or lines can be connected to the adjustment mechanism.
6.3.2 should be able to smoothly knee flexion and extension, the minimum angle of flexion should not exceed 70 °.
6.4 Hip member
It should be able to smoothly hip flexion and extension, the minimum angle between hip song should not exceed 70 °.
6.5 connector
6.5.1 shift-to-wire connector regulatory function, its horizontal movement range should not be less than ± 8mm.
6.5.2 an angle adjustable connection of line functions, which adjust the angle should not be less than ± 8 °.
6.5.3 thigh rotating disk, the rotation angle should be greater than 90 °.
6.5.4 reverse buffer torsional angle should not be less than 10 °.
6.6 Material
6.6.1 make lower limb prosthesis component materials should be susceptible to moisture, corrosion, anti-corrosion treatment, the material in direct contact with the human body should be non-toxic
harmless.
6.6.2 Production of materials should be used in structural parts is higher than the value of the material strength, ease of processing and can withstand structure according to GB/T 18375 stipulated
Strength test.
6.6.3 moisture content of the wood should be less than 15%, measured by the method of GB/T 1931 regulations.
6.6.4 Soft Case decoration should make use of lightweight material having elasticity.
6.7 strength requirements
Of the load-bearing member, according to the provisions of GB/T 18375 of structural strength test, cracks may not occur, damage becomes apparent permanent
Abnormal shape and sound.
6.8 appearance requirements
6.8.1 shell type connector, and the outer surface of the housing decoration decorative soft cover should be smooth, clean and tidy.
6.8.2 Plastic surface should be smooth, uniform color, no scratches, cracks, bubbles and other defects.
6.8.3 Leather goods, should be no cuts, scratches, neatly folding, pin code uniform.
6.8.4 plating surface color should be bright, uniform, it does not allow bubbling, peeling, burning black, pitting, open at the end and other defects.
6.8.5 oxidation treatment surface should be uniform color, not allowed to have open at the end, corrosion and other defects.
7 Inspection Method
7.1 performance test
7.1.1 ankle plantar flexion member deformation measurement method
Determination of ankle plantar flexion deformation member as shown in Fig. 5. Vertical load exerted by the pressure of 400N, recording heel compression
Deformation was repeated three times and averaged.
Figure 5
7.1.2 Determination of ankle dorsiflexion deformation member
Determination of ankle dorsiflexion deformation member as shown in Figure 6. Vertical load exerted by the pressure 400N, the recording becomes upturned toe
Shaped volume, repeated three times and averaged.
Note. H is false high heels.
Figure 6
7.1.3 inner ankle means for measuring the angle of external rotation method
7, with the horizontal plane parallel to the axis of the ankle 20N · m torque is applied, the measuring, the angle of external rotation, repeated three times, and the flat
Mean.
7.1.4 inner ankle member valgus angle measurement method
8, about the longitudinal axis of the foot is applied to the frontal plane, as shown in Figure 50N · m moments, measuring valgus angle, repeated three times and averaged.
Figure 7
Figure 8
7.1.5 The minimum knee flexion angle measurement method
The extreme limit of knee flexion, the joint body and the measuring longitudinal axis of the body under the joint angle formed.
7.1.6 Determination of the hip joint flexion angle of the smallest
The hip flexion limit position is placed on the measurement of the joint body and the lower body joint forming an angle to the longitudinal axis.
Determination connection translation adjustment range 7.1.7
In connection horizontal plane center position as a reference measurement before and after the horizontal plane around the maximum travel distance.
7.1.8 connecting member is rotated to adjust the angle of the measurement method
In connecting member axis vertical position as a benchmark to measure the maximum angle axis in sagittal and frontal plane deflection.
7.1.9 Determination thigh rotating disk rotation angle
Level measurement in the thigh rotating disk rotation.
7.1.10 Determination of axial torsion angles of rotation buffer
About a longitudinal axis applied to 4.5N · m of torque were measured its rotation in both clockwise and counter-clockwise angle.
7.2 appearance inspection method
Exterior visual inspection methods, and control standard assessment.
7.3 Test site conditions
Test site temperature of 5 ℃ ~ 35 ℃, relative humidity of 25% to 95%.
8 Inspection Rules
8.1 factory inspection
8.1.1 lower limb prosthetic components should be tested before delivery, product inspection certificate issued.
8.1.2 factory inspection project Chapter 5, 6.1,6.2,6.3,6.4,6.5 and 6.8.
8.2 Type inspection
The entire contents of Chapters 5 and 6 of Chapter 8.2.1 type test according to the standards of conduct.
8.2.2 When one of the following conditions, type of inspection should be carried out.
a) new products or old products to the plant production trial to identify stereotypes;
B) after the official production, such as structure, materials, technology has greatly improved product performance and possible impact strength;
c) mass production, product quality and periodic inspection;
d) one year after the product discontinuation, resume production;
e) the national quality supervision bodies type inspection requirements.
9 Rules for sampling
9.1 type test sample for the main structural inspection to take four, take two auxiliary structure inspection, sample testing the quality of periodic inspection once a year.
9.2 Test samples shall be subject to factory inspection, factory inspection randomly from the qualified products.
9.3 type inspection sample has an unqualified, doubling the number of samples can be extracted repeated testing, repeat testing is still 1
When members qualified, this batch failed.
9.4 Sample type inspection when there is failure, then this installment failed 2.
9.5 parts through structural strength test should no longer be qualified products for prosthesis.
10 signs, packaging, transportation and storage
10.1 Flag
10.1.1 Each factory as a single piece parts shall be marked with the item number mark.
10.1.2 prosthetic foot and ankle parts should be marked foot long, high heel, and soft and hard about.
10.1.3 shell and tube legs, decorative shell and decorative cover should be marked soft calf girth and around.
10.1.4 housing style ankle and knee housing type should be marked serial number.
10.2 packaging, transport
10.2.1 each component should be installed in the dust bag, there are dark parts requirements apply dark bags.
10.2.2 packaging bag must be loaded into the certificate, the certificate should have at least the following.
a) name of the manufacturer;
b) the product name and model number;
c) serial number;
d) the date of manufacture.
10.2.3 User's Guide and quality packaging products should ensure that a single bag.
10.2.4 shipping container shall comply GB/T 9174, the Packaging - Pictorial signs should be consistent GB/T 191 requirements.
10.3 Storage
Packed full of prosthetic components should be stored in ventilated, dry coffers, and with flammable and corrosive chemicals and other substances isolation.
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