GB22457-2025

Service of prosthesis fitting

假肢配置服务

GB 22457-2025 は施行予定の中国強制国家規格です：Service of prosthesis fitting。業界：食品。テーマ：製品安全。施行日：2026年11月1日。

適用可否は製品範囲、認証ルート、所管当局の通知、移行規定によって異なります。コンプライアンス判断に使う前に、翻訳をご依頼いただくか公式情報源をご確認ください。

コンプライアンス概要

この概要は現在英語のみで提供しています。

適用範囲

This standard applies to institutions engaged in prosthesis fitting services. It specifies the general requirements, service guarantees, service processes, and evaluation methods for prosthesis configuration. It is mandatory for all organizations providing these services in China. It references related component standards such as GB 14723 and GB/T 18027.

技術要求

The standard outlines comprehensive service guarantees including institutional framework, personnel qualifications, and facility requirements. Facilities must comply with GB 50763 for accessibility. Organizations must maintain service records for at least 15 years. It details the complete service workflow from reception, medical assessment, and prescription formulation to manufacturing and delivery. The standard mandates that the prosthesis manufacturing process should be completed within 30 days of signing the agreement. Strict quality inspections are required, including initial and final fitting checks to ensure alignment, suspension, and functionality meet the prescription. Institutions must provide a warranty card and product manual upon delivery. After-sales service must respond to user issues within 2 working days.

試験方法

The standard does not specify laboratory testing methods for materials but focuses on clinical assessment and fitting evaluations. Key evaluations include initial fitting checks (alignment, suspension, joint mobility) and final fitting checks (cosmetic appearance, component reliability, operational functionality). It also requires comprehensive rehabilitation training assessments before and after prosthesis manufacturing.

よくある質問

What products are regulated under GB 22457-2025?

GB 22457-2025 regulates the service of prosthesis fitting rather than specific products. It applies to institutions providing upper and lower limb prostheses, referencing component standards like GB 14723 for lower limbs and GB/T 18027 for electric upper limbs.

Are there any updates from the previous version of GB 22457?

Yes, compared to GB 22457-2008, the 2025 version updates personnel requirements, adds safety production training, modifies assessment criteria (e.g., adding vision and surface EMG checks), and removes packaging and transportation requirements.

What are the documentation requirements for compliance?

Institutions must maintain detailed records including basic information forms, assessment forms, measurement forms, and prescriptions. These archives must be preserved for a minimum of 15 years.

The summary above provides a high-level overview of GB 22457-2025. To ensure complete compliance for your prosthesis fitting services in the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 22457-2025 today to access all detailed parameters, tables, and service procedures.

適用のヒント

種別: 安全
CCS: C45
ICS: 11.040.40
所管部門: Ministry of Civil Affairs
技術委員会: National Technical Committee on Rehabilitation and Assistive Devices for Persons with Disabilities of Standardization Administration of China