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GB 14722-2008: Modular hip disarticulation prosthesis, Modular knee disarticulation prosthesis and modular above knee prosthesis
Status: Valid GB 14722: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB 14722-2008 | English | 419 |
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Modular hip disarticulation prosthesis, Modular knee disarticulation prosthesis and modular above knee prosthesis
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GB 14722-2008
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| GB 14722-1993 | English | 559 |
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Endoskeletal above knee prosthesis
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GB 14722-1993
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PDF similar to GB 14722-2008
Basic data | Standard ID | GB 14722-2008 (GB14722-2008) | | Description (Translated English) | Modular hip disarticulation prosthesis, Modular knee disarticulation prosthesis and modular above knee prosthesis | | Sector / Industry | National Standard | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 18,193 | | Date of Issue | 2008-09-19 | | Date of Implementation | 2009-03-01 | | Older Standard (superseded by this standard) | GB 14722-1993 | | Quoted Standard | GB/T 191; GB/T 3293; GB/T 9174; GB/T 10000; GB/T 14191; GB 14723; GB/T 18375 | | Regulation (derived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 above the knee (including knee disarticulation) amputees using modular hip, knee and thigh prosthesis models, technical requirements, test methods, inspection rules and signs, packaging, transport and storage. This standard applies to modular hip, knee and thigh prosthesis design, production, assembly and acceptance. | GB 14722-2008: Modular hip disarticulation prosthesis, Modular knee disarticulation prosthesis and modular above knee 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 hip disarticulation prosthesis, Modular knee disarticulation prosthesis and modular above knee prosthesis
ICS 11.040.40
C45
National Standards of People's Republic of China
Replacing GB 14722-1993
Modular hip, thigh and knee prostheses
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
Preface Ⅰ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 Model 1
5 2 Technical Requirements
6 Inspection Method 5
7 Inspection rules 6
8 signs, packaging, transportation, storage 6
Appendix A (normative) medical prostheses 8
Appendix B (normative) prosthetic prescription 9
Annex C (normative) quadrilateral receiving chamber thigh prostheses meter 10
Annex D (normative) prosthetic thigh ischial containment receiving chamber 11 meter
Appendix E (normative) knee disarticulation prostheses 13 meter
Annex F (normative) hip disarticulation prostheses 14 meter
Foreword
Chapter 5 of this standard are mandatory, the rest are recommended.
This standard replaces GB 14722-1993 "type thigh bone prostheses."
This compared with GB 14722-1993 standard has the following changes.
--- Change the standard name;
--- Adds intelligent prosthetic knee, foot and storage silicon (condensate) plastic inner liner and other new products, new technologies and technical content of the new material.
The Standard Appendix A, Appendix B, Appendix C, Appendix D, Annex E and Annex F are normative appendix.
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. Beijing orthopedic Ruiha International Trade Co., Ltd., China orthopedic technical secondary schools, Shanghai
Prosthetics Factory Co., Ltd., Guangdong Province, physical rehabilitation centers.
The main drafters. Zhang Rui, Yangcheng Rui, Fang Xin, Lvyong Bing, Bing Xiang District, Wuxi Han.
This standard was first released in 1993.
This standard is the first revision.
Modular hip, thigh and knee prostheses
1 Scope
This standard specifies the above the knee (including knee amputation) modular hip amputees use, knee and thigh prosthetic models, skills
Operation requirements, test methods, inspection rules and signs, packaging, transportation and storage.
This standard applies to modular hip, knee and thigh prosthetic design, manufacture, assembly and inspection.
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 study whether according to the agreement
You can use 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 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 14723 lower limb prosthesis common parts
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
Having amputees parameter sampled by computer processing, to achieve the support of the swing or adaptive control of the sensor in the knee by Walking
joint.
3.2
You can adjust the height of the heel ankle fake components.
4 Model
4.1 Model composition
Component type prosthetic leg by product code and type codes receiving chamber components. Consisting of the following form.
Product Code
receiving chamber type codes
4.2 Product Code
With "AK" represents modular hip prostheses;
With "TK" indicates modular knee prostheses;
With "TH" indicates modular hip prostheses.
4.3 receiving chamber type codes
Arabic numerals of different receiving chamber type code, as shown in Table 1.
Table 1 receiving chamber type codes
Type pelvic cavity Inclusive accepted
quadrilateral
(Transverse oval)
Ischial inclusive
(Longitudinal oval)
Bearing knee formula
Code 1234
4.4 Example
Example 1. AK2 quadrilateral represents acceptance of thigh prosthetic cavity.
Example 2. TK4 formula represents bearing knee prosthetic knee receiving cavity.
5 Technical requirements
5.1 Technical Documentation
Production Component thigh prostheses must be completed in technical documents. Documents include medical prostheses, meter and prosthetic prescription. Human foot
Inch measurement should be consistent with GB/T 10000 requirements, see Appendix A, Appendix B, Appendix C, Appendix D, Appendix E and Appendix F.
5.2 Structure
5.2.1 thigh prostheses and prosthetic knee by a receiving chamber, knee, ankle, connectors, prosthetic foot and the outer decorative cover components.
5.2.2 receiving chamber by the prosthetic hip, hip, knee, ankle, connectors, prosthetic foot and the outer decorative cover components.
5.2.3 modular hip, thigh and knee prosthetic components used should meet the requirements of GB 14723.
5.3 receiving chamber
5.3.1 receiving chamber type
5.3.1.1 pelvic cavity should be inclusive to accept the entire pelvis inclusive receiving chamber stump side should have sufficient strength to support the weight and disposable prosthetics;
Healthy limb side should have a certain elasticity easy to wear off. Ischial tuberosity as the main anchorage stump side. Bottom of the receiving chamber shape should ensure that the whole stump
Surface contact. Edge-receiving chamber on both sides of the iliac crest should be inclusive to ensure that the suspension, which should be at waist height flexion 90 °, the costal margin without undue pressure prevail,
See Figure 1.
Figure 1
5.3.1.2 quadrilateral receiving chamber whose mouth anteroposterior (A-P) less than the outer diameter (M-L); the inside edge of the rear wall is formed with the ischial bearing platform;
Front wall stump respond with appropriate pressure to ensure that the load-bearing ischial tuberosity (Figure 2).
Figure 2
5.3.1.3 ischial inclusive receiving chamber whose mouth anteroposterior (A-P) is greater than the inner and outer diameters (M-L); accept the ischial tuberosity and ischial containment chamber
Support, within the line of the femur close, see Fig.
Figure 3
5.3.1.4 knee bearing type receiving chamber and its main load-bearing parts of the stump; cavity soft liner full contact with the residual limb; the area outside the femur
We should face pressure to ensure the suspension and control prosthetics. To stump bearing receiving cavity catchy type region should be a certain degree of flexibility, so that the stump
No discomfort when walking and sitting, shown in Figure 4.
Figure 4
5.3.2 receiving chamber requirements
5.3.2.1 Full load-bearing parts in contact with the stump, wearing comfortable without pain.
5.3.2.2 quadrilateral and depth of the ischial inclusive receiving chamber should be consistent with the length of the stump, stump longer than allowed 0mm ~ 20mm.
5.3.2.3 accept the edge of the front wall of the cavity height should be when the hip flexion 90 °, do not make too much pressure groin prevail.
5.3.2.4 on the mouth edge shaped to conform to the design requirements, uniform thickness, smooth edge, burr-free transition.
5.3.2.5 outer wall smooth.
5.3.3 receiving chamber material
5.3.3.1 should be non-toxic and non-irritating to humans, after forming malleable polymer material, for example, acrylic resins, polyethylene,
Acrylic sheet metal.
5.3.3.2 should choose the appropriate type and number of layers according to the weight of the patient and the use of polypropylene degreased, nylon, polyester, cotton fiber and
Carbon fiber and other reinforcing material.
5.3.3.3 synthetic resin reinforced with a composite material made of a thermoplastic or accept cavity wall made of sheet metal, it should meet the physical and mechanical properties
Table 2 together with the requirements.
Table 2 receiving chamber material physical and mechanical performance indicators
Tensile strength/MPa Bending strength/MPa Impact strength/(J/m2) Elastic Modulus/MPa
> 29.4 > 49.0 > 5.9 × 104 > 490.0
5.4 soft liner
5.4.1 The seams should be strong adhesion, a clean, flat surface.
5.4.2 should be docile in molding plaster male mold, each part of uniform thickness.
5.4.3 receiving chamber should be higher than the upper edge of mouth and even higher than 3mm ~ 10mm smooth transition.
5.4.4 4mm ~ 6mm thickness should be used on the human body non-toxic, non-irritating, flexible material, such as polyethylene foam panels. its
Physical and mechanical properties should not be less than the requirements in Table 3.
Table 3. Physical and mechanical performance of soft liner
Tensile strength/MPa 100% elongation strength/MPa Elongation at break /%
> 1.5 > 0.75 > 120.0
5.5 silicon (condensate) pouches
5.5.1 In accordance with the appropriate parts of the stump end girth measured level, select the appropriate size of silicon (condensate) pouches.
5.5.2 Put on silicon (condensate) pouches should be fully obedient stump, without gaps.
5.5.3 upper edge use special scissors or special tools cut into wavy; use special fabric with a glue edge treatment.
5.5.4 Application of the pH-neutral detergent.
5.6 decoration sets
5.6.1 Application decoration set made of flexible foam material, to ensure that the prosthesis is not easy to break flexion.
5.6.2 decoration should be set lower adhesive connection with the ankle plate (cover), and detachable.
5.6.3 decoration should cover the upper chamber is connected with the acceptance of cover bonding connection, and then the receiving chamber connected to the fixed and removable.
5.6.4 decoration should be polished smooth mantle surface, no scratches, shape and healthy limb side is similar.
5.7 Hip
5.7.1 Plate holder shall meet the hip prosthesis in amputees need for internal and external rotation on the line requirements.
5.7.2 Front should meet after hip prosthesis in amputees need for flexion, extension and internal and external rotation of the line requirements.
5.8 knee
5.8.1 manual lock knee uniaxial knee should be locked in the extended position of function.
5.8.2 uniaxial load-bearing self-locking of the knee should be implemented in support of the knee locked in the extended position by the function of the mechanical structure.
5.8.3 uniaxial mechanical control of the knee should have constant swing features.
5.8.4 uniaxial liquid (gas) pressure swing phase control knee flexion and extension should have the swing of variable damping function.
5.8.5 axis hydraulic knee control should have the support of stable and variable swing phase flexion damping function.
5.8.6 multi-axis machine control knee joint should have a stable and constant support of the swing function.
5.8.7 Multi-axis manual locking knee should be locked in the extended position the knee function.
5.8.8 Multi-axis fluid (gas) pressure swing phase control knee stability should have the support of swing flexion of variable damping function.
5.8.9 intelligent control by sensors should have knee amputees parameter sampling Walking through computer processing, and support of, or
Swing phase adaptive control functions.
5.9 Ankle
5.9.1 uniaxial ankle should be able to simulate the human plantar flexion, dorsiflexion function.
5.9.2 Universal ankle should be able to simulate human plantar flexion, dorsiflexion and inner valgus functions for rough road to walk.
5.9.3 adjustable feet should be able to adjust the angle of the ankle, heel height shoe for different amputees use.
5.10 prosthetic foot
5.10.1 prosthetic foot should be approximately the shape of a human foot, the same model can be put on the contralateral shoe, shoe size should be consistent with GB/T 3293 requirements.
5.10.2 When the prosthetic foot contact with the ground should have a sufficient buffer capacity and resilience.
5.10.3 should choose the type of prosthetic foot and heel height according to the amputee's own habits and requirements.
5.10.4 SACH foot, single-axis feet and Swivel Feet should be equipped with the corresponding ankle.
5.10.5 feet should have storage energy storage and release functions to reduce the movement of the wearer's energy consumption.
5.11 Connection
5.11.1 using wood lands directly connected with the receiving chamber, the outer surface of the secondary should be evacuated process reinforcement.
5.11.2 metal fittings direct connection with the chamber accepted, shall ensure that the combined strength of the joint between the composite material layer, and
Connecting member buried in the local region of the cavity portion strength to accept.
5.11.3 other ways to connect with the receiving chamber should ensure the strength of the connection, solid and reliable.
5.11.4 before delivery amputees use to deal with the various joints fastening screws locking process.
5.12 Suspension mode
5.12.1 should adsorption-type suspension, the valve hole location should ensure easy amputees worn, pipe and valve receiving chamber connection should be as close contact
By the bottom of the cavity, and firm adhesion does not leak.
Belt joints and acceptance chamber should be solid and reliable when using 5.12.2 plus belt hanging manner.
5.12.3 silicon (condensate) prosthetic thigh pouches suspended in the bottom of the receiving chamber of the preset lock seat should guarantee stable and reliable.
5.12.4 Use sealing silicon (condensate) prosthetic thigh pouches suspended in the receiving chamber to be formulated special valve.
5.13 pairs of lines
5.13.1 Workbench line
Workbench line should be based on receiving chamber forms and instructions provided by the manufacturer of the product to determine the receiving chamber, connectors, joints and prosthetic feet
Relatively relations.
5.13.2 Static on the line
Amputees natural stand, adjust the stability of the prosthesis, and the angle of rotation symmetry with the contralateral prosthetic foot outside.
5.13.3 Dynamic line
Observation amputee walking gait, through adjustments to the prosthesis near normal gait.
5.14 appearance
5.14.1 shape should be approximately the healthy limb.
5.14.2 color should approximate color.
5.14.3 decoration should be equipped with outer sheath color sock.
5.15 Dimensions
5.15.1 height should be equal with the contralateral, allowing lower than the contralateral 0mm ~ 10mm.
5.15.2 amputee sitting thigh length should be equal with the contralateral, contralateral longer than allowed 0mm ~ 20mm; with the contralateral leg height should be equal, allowing
Xu higher than the contralateral 0mm ~ 20mm.
5.16 Quality
5.16.1 hip prosthesis (normal configuration) quality should not exceed 5kg.
(Normal preparation) Quality 5.16.2 thigh prosthesis should be less than 3.5kg.
(Normal configuration) 5.16.3 quality prosthetic knee should be less than 3.5kg.
5.17 Strength
5.17.1 Metal parts shall comply with GB/T 18375 of.
5.17.2 prosthetic foot shall comply with GB/T 18375 of.
5.18 receiving chamber lifespan
Under normal circumstances receiving chamber should be able to use more than 24 months.
6 test method
6.1 inspection tool
Measuring tape, ruler, measuring receiving cavity week, pelvis level gauge, angle ruler, vernier calipers, scales, on-line platform, depth gauge, line
Fall and so on.
6.2 strength test
Strength test according to the provisions of GB/T 18375 performed.
6.3 receiving chamber test
6.3.1 inner peripheral dimension provided with peripheral measuring device.
6.3.2 Depth using the depth gauge.
6.3.3 smooth wall and rounded edges on the degree of visual mouth with a hand.
6.3.4 Physical and mechanical properties should be formulated with conventional processes standard spline inspection.
6.3.5 Lip shape measurement and visual inspection with a ruler.
6.3.6 suitability by the amputee to try and listen to visually amputees readme.
6.4 soft liner and silicon (condensate) test pouches
6.4.1 thickness with a caliper.
6.4.2 edge height with a ruler.
6.4.3 visual quality bonding with feeling.
6.4.4 Physical and mechanical properties of materials should be routinely used standard spline inspection.
6.5 Test set decoration
6.5.1 amputees with artificial limbs after wear, for knee and hip flexion movements, observe the outer decorative cover stretched state changes.
6.5.2 visual prosthetic shape and color.
6.6 pairs of wire test
6.6.1 on the line in accordance with the requirements of the prosthesis, the prosthesis will remain on-line platform for measuring the state of the parties position on the line.
6.6.2 amputees with prosthetic wear after standing on the ground, and the angle of rotation symmetry observed heel touches the ground, the contrast with the healthy limb prostheses prosthetic foot outside
degree.
6.6.3 amputees prosthetic be worn after walking on a variety of road, down stairs and squatting and other sports, to observe any abnormal.
6.7 Dimensional inspection
6.7.1 prosthetic height measurement on the platform with a ruler.
6.7.2 amputees with artificial limbs after wearing natural stand, measured using a spirit level pelvis iliac crest level to determine the degree of prosthetic height.
6.7.3 amputee sitting, hip and knee flexion 90 °, measuring the length of the thigh and calf height with a ruler.
6.7.4 prosthetic length measuring with a ruler.
6.7.5 girth with a tape measure ministries.
6.8 Quality inspection
Use Precision Quality Inspection of 10kg for the two scales.
7 Inspection rules
7.1 When the synthetic resin and reinforcing materials used in the following circumstances, shall be as specified in 6.3.4 Re-submission.
a) synthetic resin grades species change;
b) to enhance the quality of the material change;
c) change the amount of reinforcing material.
7.2 test content and methods in accordance with Chapter 5 and 6 of the provisions of the chapter.
7.3 product before delivery, the test and issue a product certificate.
7.4 When the quality or thickness using the thermoplastic sheet changes should be re-inspected as specified in 6.3.4.
7.5 When the quality or thickness of the flexible sheet used to change the provisions of 6.4.4 should be re-inspection.
8 signs, packaging, transportation and storage
Signs, packaging, transportation, storage should be consistent with GB/T 191 and GB/T 9174 provisions.
8.1 mark
Should be marked in the appropriate parts of each product marked product model, a mark should be the following.
a) name and address of manufacturing units;
b) Product Name Model;
c) the date of manufacture;
d) trademark.
8.2 Packaging
8.2.1 Each product should be stored in a dark dust bag.
8.2.2 dust bag should be loaded certificate, instruction manual and warranty card.
8.3 Transport
8.3.1 Transport should avoid bump, pressure and humidity.
8.3.2 Transport process should avoid contact with flammable and corrosive chemical and other harmful substances.
8.4 Storage
Packed full of products should be stored in a dry place, and avoid pressure and isolate it with flammable and corrosive chemical and other harmful substances.
Appendix A
(Normative)
Medical prostheses
Name. Gender. Country (Region). Nationality. patient medical record number.
Age. Height. cm Weight. kg
ID Category. □ □ □ Passport identification officers (soldiers) certificate □ Other
ID Number.
Phone. Address. Zip Code.
Home Address. Employer.
Amputation Cause. Amputation time. date amputation.
History (medical history, medical history, family history).
Other situations should be noted.
Admissions Signature. visit Date. The date
Appendix B
(Normative)
Prosthetic prescription
Name. Sex. Age. the age of the patient medical record number.
Limb missing parts. Prostheses Name.
□ □ receiving chamber single-chamber double (lumen + external cavity)
□ external cavity material
□ □ domestic imports
□ □ resin sheet □ Other.
□ □ cavity material thermoplastic foam board □ □ □ leather silicone □ Other.
Receiving chamber type plug-in □ □ □ full-contact adsorption type □ Other
Prosthetic structure. □ □ shell-type skeleton
Number Name Type Manufacturer Name Type Quantity Manufacturer
Hip Shoulder
Knee and elbow
Ankle Hand
annex.
special requirements.
(Signed by patients or their families) agreed over the prosthetic fitting choice.
Prosthetic production division (signature). Fill Time. The date
Appendix C
(Normative)
Quadrilateral receiving chamber thigh prostheses meter
Name Sex Age
About height and weight amputation
Prosthetic type measurement date date
Before repairing after Modification
Ischial ischial
5cm 5cm
10cm 10cm
15cm 15cm
20cm 20cm
25cm 25cm
Production technicians take samples Type Date Date
Appendix D
(Normative)
Ischial containment receiving chamber thigh prostheses meter
Name Sex Age
About height and weight amputation
Prosthetic type measurement date date
Name. Patient medical record number.
Stump measurement and design
interval
X =
Stumps
Elastic
Pre-designed value
1 × X =
2 × X =
3 × X =
4 × X =
5 × X =
6 × X =
7 × X =
Stump length
Signature Measurement. Measurement time. date
Appendix E
(Normative)
Knee disarticulation prostheses meter
Name Sex Age
About height and weight amputation
Prosthetic type measurement date date
Girth dimension control.
Before repairing after Modification
Ischial ischial
5cm 5cm
10cm 10cm
15cm 15cm
20cm 20cm
25cm 25cm
30cm 30cm
Production technicians take samples Type Date Date
Appendix F
(Normative)
Hip disarticulation prostheses meter
Name Sex Age
About height and weight amputation
Prosthetic type measurement date date
Production technicians take samples Type Date Date
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