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Service of prosthesis fitting
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Service of fitting prosthesis
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Basic data
| Standard ID | GB 22457-2025 (GB22457-2025) |
| Description (Translated English) | Service of prosthesis fitting |
| Sector / Industry | National Standard |
| Classification of Chinese Standard | C45 |
| Classification of International Standard | 11.040.40 |
| Word Count Estimation | 30,349 |
| Date of Issue | 2025-10-31 |
| Date of Implementation | 2026-11-01 |
| Older Standard (superseded by this standard) | GB 22457-2008 |
| Issuing agency(ies) | State Administration for Market Regulation, Standardization Administration of China |
GB 22457-2025: Service of prosthesis fitting
---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 11.040.40
CCSC45
National Standards of the People's Republic of China
Replaces GB 22457-2008
Prosthetic fitting service
Published on 2025-10-31
Implemented on 2026-11-01
State Administration for Market Regulation
The State Administration for Standardization issued a statement.
Table of contents
Preface III
Introduction IV
1.Scope 1
2 Normative References 1
3.Terms and Definitions 1
4.General Requirements 1
5 Service Guarantee 2
5.1 System Development 2
5.2 Personnel 2
5.3 Facilities and Equipment 2
5.4 Environment 2
5.5 Training 2
6.Service Process and Requirements 2
6.1 Reception 2
6.2 Inspection and Evaluation 3
6.3 Signing a prosthetic limb provision agreement 3
6.4 Prescribing a prosthesis 3
6.5 Configuration cycle 4
6.6 Rehabilitation training before prosthesis fabrication 4
6.7 Prosthetics Fabrication 4
6.8 Prosthetic limb use training 4
6.9 Quality Inspection 4
6.10 Prosthetic delivery 5
6.11 After-sales service 6
7 Evaluation and Improvement 6
7.1 Evaluation 6
7.2 Improvements 6
Appendix A (Normative) Basic Information Form for Persons with Limb Disabilities 7
Appendix B (Normative) Prosthetic Fitting Inspection and Evaluation Form 8
Appendix C (Normative) Prosthetic Fitting Dimension Measurement Table 9
Appendix D (Informative) Example 18 of a Prosthetic Fitting Agreement
Appendix E (Normative) Prosthetic Prescription 20
Appendix F (Informative) Example 21.Prosthetic Fitting Warranty Card Format
Appendix G (Informative) Example 22 of Prosthetic Fitting Product Instruction Manual
Appendix H (Informative) Example 24 of a follow-up record for prosthetic fitting
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 22457-2008 "Prosthetic Limb Fitting Services". Compared with GB 22457-2008, it has only undergone structural adjustments and editorial changes.
In addition, the main technological changes are as follows.
---The definition of "prosthetic configuration" has been changed (see 3.1,.2008 version 3.1);
---Added terms and definitions for the "Prosthetic Fitting Record Form" (see 3.3);
---Personnel requirements have been changed (see 5.2, 5.2.1 of the.2008 version);
---The requirements for accessibility facilities have been revised, referencing GB 50763 (see 5.3, 5.2.3 of the.2008 edition);
---The training requirements have been revised to include training on safe operating procedures (see 5.5, 5.3 in the.2008 version);
---The requirements for examination and assessment have been changed, adding examinations of vision and surface electromyography signals for upper limb amputees, while removing requirements for psychological state, etc.
Neurological examination and assessment (see 6.2, 6.3 in the.2008 edition);
---The composition of prosthetic fitting service fees has been changed (see 6.3, 6.5 in the.2008 version);
---The preparation requirements for prosthetic fitting have been changed (see 6.6, 6.7 in the.2008 version);
---The quality inspection requirements for prosthetic fittings have been changed (see 6.9, 6.10 in the.2008 version);
---The requirement for a "certificate of conformity" has been removed (see 7.2.1 in the.2008 version);
---The requirements for marking, packaging, transportation, and storage have been removed (see Chapter 8 of the.2008 edition);
---Follow-up requirements have been changed (see 6.11, Chapter 9 of the.2008 edition);
---The prosthesis fitting checklist, prosthesis fitting size measurement table, and prosthesis prescription (see Appendix B, Appendix C, and Appendix E,.2008 edition) have been revised.
Appendix B, Appendix C, and Appendix E).
Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.
This document was proposed and is under the jurisdiction of the Ministry of Civil Affairs of the People's Republic of China.
The release history of this document and the document it replaces is as follows.
---First published in.2008 as GB 22457-2008;
---This is the first revision.
Introduction
Prosthetic fitting services are a highly specialized, individualized, and technically demanding profession that requires specialized fabrication facilities and equipment.
The process must be conducted according to scientific and standardized procedures and standards. Prosthetic fitting services involve the health and safety of people with disabilities; improper fitting can not only reduce the wearing comfort of the device...
If comfort, motor coordination, and compensatory functions are not improved, the expected rehabilitation effect may not be achieved, and the disability may even be aggravated.
Due to differences in the development level and scale of institutions providing prosthetic fitting services, the processes involved in prosthetic fitting, including reception, examination and evaluation, and signing of fitting agreements, vary.
Services include consultation, prescription issuance, preparation cycle, pre-production rehabilitation training, production, usage training, configuration quality inspection, delivery, and after-sales service.
The requirements and standards are inconsistent. Furthermore, without corresponding standards and regulations to constrain the service quality of prosthetic fitting institutions, service deficiencies may occur.
The rights of disabled persons are not effectively protected in quality disputes or liability determinations. Therefore, the formulation of this document is both necessary and urgent.
The formulation and release of this document will play a positive role in regulating the behavior of providers of prosthetic limb fitting services and protecting the rights and interests of people with disabilities.
Prosthetic fitting service
1 Scope
This document specifies the general requirements, service guarantees, service procedures and requirements, evaluation and improvement of prosthetic fitting services.
This document applies to organizations that provide prosthetic fitting.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
GB/T 14191.1 Terminology of Prosthetics and Orthotics Part 1.Basic Terminology of External Limb Prostheses and External Orthotics
GB 14723 General components for lower limb prostheses
GB/T 18027 Electric upper limb prosthetic components
GB/T 18375 Structural inspection requirements and test methods for lower limb prostheses
GB/T 19543 Structural Examination of Prosthetic Hip Joints
GB/T 31181 Requirements and test methods for ankle-foot devices and foot components of prostheses
GB 50763 Barrier-free Design Standard
MZ/T 002 Self-powered upper limb prostheses
MZ/T 220 Decorative Upper Limb Prosthetic Components
3 Terms and Definitions
The terms and definitions defined in GB/T 14191.1 and the following terms and definitions apply to this document.
3.1
Prosthesis Fitting
Activities involving fitting prostheses to people with limb disabilities and providing guidance and training.
3.2
A written document outlining a prosthetic limb configuration plan based on the individual's condition.
3.3
Documents kept by prosthesis fitting personnel to record prosthesis fitting plans and changes.
Note. This includes records of the physical examinations, assessments, rehabilitation training, and prosthesis fabrication processes provided to individuals with limb disabilities during the prosthesis fitting process.
4.General Requirements
4.1 Prosthetic fitting services should be conducted with integrity. When promoting or introducing the organization and its products, accurate information should be provided. Before signing an agreement with a person with a limb disability, a written statement should be submitted.
This is a price list for the configured products.
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