GB 22457-2025 Service of prosthesis fitting English, Anglais, Englisch, Inglés, えいご
This is a draft translation for reference among interesting stakeholders. The finalized translation (passing through draft translation, self-check, revision and verification) will be delivered upon being ordered.
ICS 55.200
CCS H 57
National Standard of the People's Republic of China
GB 22457-2025
Replaces GB 22457-2008
Service of prosthesis fitting
假肢配置服务
Issue date: 2025-10-31 Implementation date: 2026-11-01
Issued by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
the Standardization Administration of the People's Republic of China
Contents
Foreword
Introduction
1 Scope
2 Normative References
3 Terms and Definitions
4 General Requirements
5 Service Assurance
5.1 System Development
5.2 Personnel
5.3 Facilities and Equipment
5.4 Environment
5.5 Training
6 Service Process and Requirements
7 Evaluation and Improvement
7.1 Evaluation
7.2 Improvement
Appendix A (Normative) Basic Information Form for Persons with Limb Disabilities
Appendix B (Normative) Prosthesis Fitting Examination and Assessment Form
Appendix C (Normative) Prosthesis Fitting Dimensional Measurement Form
Appendix D (Informative) Example of Prosthesis Fitting Agreement
Appendix E (Normative) Prosthesis Prescription
Appendix F (Informative) Example of Prosthesis Fitting Warranty Card
Appendix G (Informative) Example of Prosthesis Fitting Product Instructions
Appendix H (Informative) Example of Prosthesis Fitting Follow-up Record Form
Prosthesis Fitting Service
1 Scope
This document specifies the general requirements, service assurance, service processes and requirements, evaluation, and improvement for prosthesis fitting services.
This document is applicable to institutions engaged in providing prosthesis fitting services.
2 Normative References
The contents of the following documents constitute indispensable provisions of this document through normative reference in the text. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
GB/T 14191.1 Prosthetics and Orthotics - Vocabulary - Part 1: General terms for external limb prostheses and external orthoses
GB 14723 General Components for Lower Limb Prostheses
GB/T 18027 Components for Electric Upper Limb Prostheses
GB/T 18375 Prostheses - Structural testing of lower-limb prostheses - Requirements and test methods
GB/T 19543 Prostheses - Structural testing of hip joints
GB/T 31181 Prostheses - Ankle-foot devices and foot units - Requirements and test methods
GB 50763 Code for Design of Accessibility
MZ/T 002 Body-Powered Upper Limb Prostheses
MZ/T 220 Cosmetic Upper Limb Prosthesis Components
3 Terms and Definitions
The terms and definitions defined in GB/T 14191.1 and the following apply to this document.
3.1 Prosthesis Fitting
The activity of assembling a prosthesis for a person with limb disability and providing guided training.
3.2 Prosthesis Prescription
A written document proposing a prosthesis fitting solution based on the specific condition of the person with limb disability.
3.3 Prosthesis Fitting Record
A document where the prosthesis fitter records the fitting plan and any changes.
Note: It includes records of the physical examination and assessment, rehabilitation training, and prosthesis fabrication process provided to the person with limb disability.
4 General Requirements
4.1 Prosthesis fitting services shall be provided with integrity. When publicizing the institution and its products, information shall be provided truthfully. Before signing an agreement with the person with limb disability, the price list of fitting products shall be presented.
4.2 Prosthesis fitting services shall be effective. The designed fitting scheme shall achieve the purpose of replacing and compensating for the function of the missing limb.
4.3 A first-consultation responsibility system shall be implemented for prosthesis fitting. If the first-consultation prosthesis fitter changes, the person with limb disability shall be informed. The successor shall sign in the corresponding position of the first-consultation fitter.
4.4 The prosthesis fitting process shall have a reasonable division of labor with clear responsibilities assigned to individuals, implementing a signature system.
4.5 Persons with limb disabilities shall be respected, and their privacy shall be protected. Operations that might expose their privacy shall be performed with appropriate cover.
4.6 Safety protection measures shall be provided during prosthesis fabrication and rehabilitation training.
4.7 The service process shall be recorded and archived. The files shall include at least the Basic Information Form of the person with limb disability, the Prosthesis Fitting Examination and Assessment Form, the Prosthesis Fitting Dimensional Measurement Form, and the Prosthesis Prescription. The files shall be kept for at least 15 years.
5 Service Assurance
5.1 System Development
5.1.1 Systems for human resource management, safety management, and archive management shall be established.
5.1.2 A quality management system shall be established to monitor the quality of the entire prosthesis fitting process.
5.2 Personnel
Shall possess professional knowledge and operational skills in prosthesis fitting services.
5.3 Facilities and Equipment
Prosthesis fitting institutions shall have the facilities and equipment necessary for the prosthesis fabrication process flow, and shall possess accessibility facilities compliant with the requirements of GB 50763.
5.4 Environment
Prosthesis fitting institutions shall possess venues for reception, fabrication, training, and accommodation to carry out prosthesis fitting services.
5.5 Training
Training on service skills, service language, service awareness, and safe production operations for the institution's personnel shall be conducted at least once per year.
6 Service Process and Requirements
6.1 Reception
6.1.1 The basic situation and needs of the person with limb disability shall be inquired about. The Basic Information Form of the Person with Limb Disability (see Appendix A) shall be filled out and signed.
6.2 Examination and Assessment
6.2.1 The first-consultation prosthesis fitter shall inquire, examine and assess the residual limb and overall physical condition of the person with limb disability, to understand the scope and degree of functional impairment, and to anticipate the compensatory capacity.
6.2.2 During the examination and assessment process, detailed records of each item shall be kept. The Prosthesis Fitting Examination and Assessment Form and the Dimensional Measurement Form shall be filled out and signed (see Appendix B and Appendix C).
The contents of the Prosthesis Fitting Examination and Assessment Form shall include at least the following information:
a) Health status:
Standard
GB 22457-2025 Service of prosthesis fitting (English Version)
GB 22457-2025 Service of prosthesis fitting English, Anglais, Englisch, Inglés, えいご
This is a draft translation for reference among interesting stakeholders. The finalized translation (passing through draft translation, self-check, revision and verification) will be delivered upon being ordered.
ICS 55.200
CCS H 57
National Standard of the People's Republic of China
GB 22457-2025
Replaces GB 22457-2008
Service of prosthesis fitting
假肢配置服务
Issue date: 2025-10-31 Implementation date: 2026-11-01
Issued by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
the Standardization Administration of the People's Republic of China
Contents
Foreword
Introduction
1 Scope
2 Normative References
3 Terms and Definitions
4 General Requirements
5 Service Assurance
5.1 System Development
5.2 Personnel
5.3 Facilities and Equipment
5.4 Environment
5.5 Training
6 Service Process and Requirements
7 Evaluation and Improvement
7.1 Evaluation
7.2 Improvement
Appendix A (Normative) Basic Information Form for Persons with Limb Disabilities
Appendix B (Normative) Prosthesis Fitting Examination and Assessment Form
Appendix C (Normative) Prosthesis Fitting Dimensional Measurement Form
Appendix D (Informative) Example of Prosthesis Fitting Agreement
Appendix E (Normative) Prosthesis Prescription
Appendix F (Informative) Example of Prosthesis Fitting Warranty Card
Appendix G (Informative) Example of Prosthesis Fitting Product Instructions
Appendix H (Informative) Example of Prosthesis Fitting Follow-up Record Form
Prosthesis Fitting Service
1 Scope
This document specifies the general requirements, service assurance, service processes and requirements, evaluation, and improvement for prosthesis fitting services.
This document is applicable to institutions engaged in providing prosthesis fitting services.
2 Normative References
The contents of the following documents constitute indispensable provisions of this document through normative reference in the text. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
GB/T 14191.1 Prosthetics and Orthotics - Vocabulary - Part 1: General terms for external limb prostheses and external orthoses
GB 14723 General Components for Lower Limb Prostheses
GB/T 18027 Components for Electric Upper Limb Prostheses
GB/T 18375 Prostheses - Structural testing of lower-limb prostheses - Requirements and test methods
GB/T 19543 Prostheses - Structural testing of hip joints
GB/T 31181 Prostheses - Ankle-foot devices and foot units - Requirements and test methods
GB 50763 Code for Design of Accessibility
MZ/T 002 Body-Powered Upper Limb Prostheses
MZ/T 220 Cosmetic Upper Limb Prosthesis Components
3 Terms and Definitions
The terms and definitions defined in GB/T 14191.1 and the following apply to this document.
3.1 Prosthesis Fitting
The activity of assembling a prosthesis for a person with limb disability and providing guided training.
3.2 Prosthesis Prescription
A written document proposing a prosthesis fitting solution based on the specific condition of the person with limb disability.
3.3 Prosthesis Fitting Record
A document where the prosthesis fitter records the fitting plan and any changes.
Note: It includes records of the physical examination and assessment, rehabilitation training, and prosthesis fabrication process provided to the person with limb disability.
4 General Requirements
4.1 Prosthesis fitting services shall be provided with integrity. When publicizing the institution and its products, information shall be provided truthfully. Before signing an agreement with the person with limb disability, the price list of fitting products shall be presented.
4.2 Prosthesis fitting services shall be effective. The designed fitting scheme shall achieve the purpose of replacing and compensating for the function of the missing limb.
4.3 A first-consultation responsibility system shall be implemented for prosthesis fitting. If the first-consultation prosthesis fitter changes, the person with limb disability shall be informed. The successor shall sign in the corresponding position of the first-consultation fitter.
4.4 The prosthesis fitting process shall have a reasonable division of labor with clear responsibilities assigned to individuals, implementing a signature system.
4.5 Persons with limb disabilities shall be respected, and their privacy shall be protected. Operations that might expose their privacy shall be performed with appropriate cover.
4.6 Safety protection measures shall be provided during prosthesis fabrication and rehabilitation training.
4.7 The service process shall be recorded and archived. The files shall include at least the Basic Information Form of the person with limb disability, the Prosthesis Fitting Examination and Assessment Form, the Prosthesis Fitting Dimensional Measurement Form, and the Prosthesis Prescription. The files shall be kept for at least 15 years.
5 Service Assurance
5.1 System Development
5.1.1 Systems for human resource management, safety management, and archive management shall be established.
5.1.2 A quality management system shall be established to monitor the quality of the entire prosthesis fitting process.
5.2 Personnel
Shall possess professional knowledge and operational skills in prosthesis fitting services.
5.3 Facilities and Equipment
Prosthesis fitting institutions shall have the facilities and equipment necessary for the prosthesis fabrication process flow, and shall possess accessibility facilities compliant with the requirements of GB 50763.
5.4 Environment
Prosthesis fitting institutions shall possess venues for reception, fabrication, training, and accommodation to carry out prosthesis fitting services.
5.5 Training
Training on service skills, service language, service awareness, and safe production operations for the institution's personnel shall be conducted at least once per year.
6 Service Process and Requirements
6.1 Reception
6.1.1 The basic situation and needs of the person with limb disability shall be inquired about. The Basic Information Form of the Person with Limb Disability (see Appendix A) shall be filled out and signed.
6.2 Examination and Assessment
6.2.1 The first-consultation prosthesis fitter shall inquire, examine and assess the residual limb and overall physical condition of the person with limb disability, to understand the scope and degree of functional impairment, and to anticipate the compensatory capacity.
6.2.2 During the examination and assessment process, detailed records of each item shall be kept. The Prosthesis Fitting Examination and Assessment Form and the Dimensional Measurement Form shall be filled out and signed (see Appendix B and Appendix C).
The contents of the Prosthesis Fitting Examination and Assessment Form shall include at least the following information:
a) Health status:
