GB/T 24437-2023 English PDF

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GB/T 24437-2023: Division and evaluation of fitting institution grade for prostheses and orthoses
Status: Valid

GB/T 24437: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 24437-2023	799	Add to Cart	6 days	Division and evaluation of fitting institution grade for prostheses and orthoses	Valid
GB/T 24437-2009	439	Add to Cart	3 days	Division of producing and assembling institution grade for prosthetics and orthotics	Obsolete

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Basic data

Standard ID: GB/T 24437-2023 (GB/T24437-2023)
Description (Translated English): Division and evaluation of fitting institution grade for prostheses and orthoses
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C45
Classification of International Standard: 11.180
Word Count Estimation: 42,415
Date of Issue: 2023-08-06
Date of Implementation: 2024-03-01
Older Standard (superseded by this standard): GB/T 24437-2009
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 24437-2023: Division and evaluation of fitting institution grade for prostheses and orthoses

---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.
ICS 11.180 CCSC45 National Standards of People's Republic of China Replace GB/T 24437-2009 Prosthetic limbs and orthotics configuration mechanism grading and assessment Published on 2023-08-06 2024-03-01 Implementation State Administration for Market Regulation Released by the National Standardization Administration Committee

Table of contents

PrefaceⅠ 1 Scope 1 2 Normative reference documents 1 3 Terms and Definitions 1 4 Classification and use of signs 2 5 Basic requirements 2 6 Classification requirements 2 6.1 Level A requirements 2 6.2 Level AA requirements 4 6.3 AAA level requirements 5 6.4 AAAA level requirements 8 6.5 Level AAAAA requirements 11 7 Rating 14 7.1 Assessment Principles 14 7.2 Assessment process 14 7.3 Evaluators15 7.4 Assessment methods 15 Appendix A (Normative) Technical Capabilities 16 A.1 Ability to independently make difficult prosthetics16 A.2 Ability to independently make difficult orthotics16 A.3 Ability to manufacture and assemble advanced prosthetics16 A.4 Ability to manufacture and assemble advanced orthotics16 A.5 Ability to independently carry out digital work on prosthetics and orthotics17 Appendix B (Normative) Select Item 18 B.1 Government or industry award selection projects 18 B.2 Government or industry honorary selection projects18 B.3 Government or industry qualification selection projects18 B.4 Third-party certification options 19 B.5 Organization’s own operation and management options 19 B.6 International Impact Selection Project 19 Appendix C (Normative) Score Sheet 20

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. This document replaces GB/T 24437-2009 "Classification of Prosthetic Orthotics Production and Assembly Mechanisms" and is consistent with GB/T 24437-2009. In addition to structural adjustments and editorial changes, the main technical changes are as follows. a) The number of divided levels has been changed, increasing the level division to 5 levels (see 4.1, Chapter 6, 4.1, Chapter 6 of the.2009 edition chapter); b) Changed the "General Provisions" to "Classification and Use of Marks" (see Chapter 4, Chapter 4 of the.2009 edition), and added the validity of the grades Deadline, review, upgrade, downgrade, inability to apply for or cancel the grade (see 4.3~4.5 and 7.2.5); c) Added “basic requirements” (see Chapter 5) and deleted the basic requirements in service quality requirements (see 5.2 of the.2009 version); d) Changed the specific requirements for business sites in AA level and above (see 6.2.1, 6.3.1, 6.4.1, 6.5.1,.2009 edition 6.2.1, 6.3.1, 6.4.1); e) The specific requirements for service facilities in each level have been changed (see 6.1.2, 6.2.2, 6.3.2, 6.4.2, 6.5.2,.2009 version 6.1.2, 6.2.2, 6.3.2, 6.4.2); f) The specific requirements for special equipment in each level have been changed (see 6.1.3, 6.2.3, 6.3.3, 6.4.3, 6.5.3,.2009 edition 6.1.3, 6.2.3, 6.3.3, 6.4.3); g) Changed "personnel qualification" in each level to "professional technical team" (see 6.1.4, 6.2.4, 6.3.4, 6.4.4, 6.5.4,.2009 edition 6.1.4, 6.2.4, 6.3.4, 6.4.4); h) Changed the specific requirements for technical capabilities in each level (see 6.1.5, 6.2.5, 6.3.5, 6.4.5, 6.5.5, Appendix A,.2009 Versions 6.1.5, 6.2.5, 6.3.5, 6.4.5); i) Added the index requirements for service quality in each level (see 6.1.6, 6.2.6, 6.3.6, 6.4.6, 6.5.6), deleted “service quality” Quantity” (see Chapter 5 of the.2009 edition); j) The specific requirements for operation and management at each level have been changed (see 6.1.7, 6.2.7, 6.3.7, 6.4.7, 6.5.7,.2009 version 6.1.6, 6.2.6, 6.3.6, 6.4.6); k) Added index requirements for innovation capabilities at AAA level and above (see 6.3.8, 6.4.8, 6.5.8); l) Added index requirements for standardized capabilities at each level (see 6.1.8, 6.2.8, 6.3.9, 6.4.9, 6.5.9); m) Added indicator requirements for selected projects in each level (see 6.1.9, 6.2.9, 6.3.10, 6.4.10, 6.5.10, Appendix B); n) "Others" are deleted (see 6.1.7, 6.2.7, 6.3.7, 6.4.7 of the.2009 version); o) Added requirements for grade assessment (see Chapter 7); p) Added "score sheet" as a normative appendix (see Appendix C). The following editorial changes have been made to this document. Change the name of the standard to "Classification and Assessment of Prosthetic Limbs and Orthotics Arrangement Mechanisms." Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed by the Ministry of Civil Affairs of the People's Republic of China. This document is under the jurisdiction of the National Standardization Technical Committee for Rehabilitation and Special Equipment for Disabled Persons (SAC/TC148). This document was drafted by. China Rehabilitation Assistive Devices Association, Jinhua Deren Rehabilitation Assistive Devices Co., Ltd., Huaibei Feilong Disabled Prosthetics Co., Ltd. Company, National Rehabilitation Assistive Devices Research Center, China Assistive Devices Center for Disabled Persons, Henan Youde Medical Equipment Co., Ltd., Shanghai Prosthetic Limb Factory Co., Ltd., Oso (Shanghai) Trading Co., Ltd., Delin Prosthetic Orthopedic Rehabilitation Equipment (Shenzhen) Co., Ltd., Delin Prosthetic Rehabilitation Equipment (Shanghai) Hai) Co., Ltd., Shanghai Kesheng Prosthetics Co., Ltd., and Gansu Provincial Rehabilitation Assistive Device Technology Center. The main drafters of this document. Zhang Pengcheng, Yan Heping, Jiang Luohui, Ma Haitao, Ma Fengling, Gao Feng, Gao Jie, Dong Zhiqian, Mao Yong, Li Qiang, Wang Haipeng, Lu Yongbing, Ma Bing, Liu Liujun, Chen Jianliang, Yao Feng, Li Xiaotang, Yang Zhanqing, Zhao Yunwu. The previous versions of this document and the documents it replaces are as follows. ---First published as GB/T 24437-2009 in.2009; ---This is the first revision. Prosthetic limbs and orthotics configuration mechanism grading and assessment

1 Scope

This document stipulates the grading and use of signs, basic requirements, grading requirements and grade assessment of prosthetic and orthotic configuration mechanisms. This document is applicable to the classification and evaluation of prosthetic and orthotic device configuration mechanisms (hereinafter referred to as "configuration mechanisms").

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document. GB/T 10001.1 Graphic symbols for public information Part 1.General symbols GB/T 10001.9 Public information graphic symbols Part 9.Accessible facilities symbols GB/T 14191 (all parts) Prosthetics and orthotics terminology GB/T 16432 Classification and terminology of rehabilitation assistive devices GB/T 19001 Quality Management System Requirements GB 22457 Prosthetic limb configuration services GB/T 24431 Prosthetics and orthotics assembly facilities and equipment GB/T 35351 Additive Manufacturing Terminology GB 50763 Barrier-free design specifications

3 Terms and definitions

The terms and definitions defined in GB/T 14191 (all parts), GB/T 16432, GB/T 35351 and the following apply to this document. 3.1 An institution that directly assembles prostheses or (and) orthotics for physically disabled people or people with physical impairments due to various reasons. Note. Prosthetic limbs and orthotics configuration mechanisms include prosthetic limb configuration mechanisms, orthosis configuration mechanisms, and prosthetic limb and orthotic device configuration mechanisms. 3.2 3D printing3D printing Based on the three-dimensional model data, the print head, nozzle or other printing technology is used to manufacture parts or real objects through material accumulation. object craftsmanship. Note. This term is often used as a synonym for additive manufacturing, also known as 3D printing. [Source. GB/T 35351-2017, 2.1.4, with modifications] 3.3 digitalization Transform a lot of complex and changeable information into measurable numbers and data, establish appropriate digital models, and introduce computers for integration ......

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