GB 22457-2025Service of prosthesis fitting (English PDF)

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);

1 Scope

GB 22457-2025 is the Chinese national standard on service of prosthesis fitting, in the field of health care technology. It carries no /T suffix, which in the Chinese system means compliance is mandatory: a product or a practice within its scope has to meet it to be lawfully made, sold or carried out in China. It was issued on 31 October 2025 by the State Administration for Market Regulation; Standardization Administration of China, and takes effect on 1 November 2026. Classification: ICS 11.040.40, CCS C45. 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 issuing body are taken from there. The clause text, the tables and the numeric limits are in the document itself, which is delivered complete in English translation.

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

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.