GB 14723-2008Units of the lower limb prosthesis (English PDF)

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

GB 14723 covers the common components of a lower limb prosthesis - the tubes, adapters, connectors and alignment devices that a prosthetist assembles into a limb - and it is what makes parts from different makers fit together. It sets the models, the dimensions and shape including the interface geometry, the technical requirements for strength and finish, the inspection methods and rules, the sampling and the provisions for marking, packaging, transport and storage. Issued on 19 September 2008, in force since 1 March 2009, replacing GB 14723-1993. This page is published from the official record of the standard held by the Chinese standards administration: the identification, the dates, the classification and the edition it replaces are taken from there. The clause text, the tables and the numeric limits are not reproduced on this page - they are in the document itself, which is delivered in full in English translation.

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.

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.

7.1.2 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 ~

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

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 °.

6.5.1 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 °.