GB22457-2025

Service of prosthesis fitting

假肢配置服务

GB 22457-2025 ist eine kommende verbindliche chinesische Nationalnorm: Service of prosthesis fitting. Branchencluster: Lebensmittel. Schwerpunkt: Produktsicherheit. Inkrafttreten: 1. Nov. 2026.

Die Anwendbarkeit hängt vom Produktumfang, dem Zertifizierungsweg, Bekanntmachungen der Behörden und Übergangsregeln ab. Fordern Sie eine Übersetzung an oder prüfen Sie die Quelle, bevor Sie diesen Eintrag für Compliance-Entscheidungen nutzen.

Compliance-Überblick

Dieser Überblick ist derzeit nur auf Englisch verfügbar.

Geltungsbereich und Anwendbarkeit

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.

Technische Anforderungen

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.

Prüfverfahren

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.

Häufige Fragen

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.

Hinweise zur Anwendbarkeit

Normtyp: Sicherheit
CCS: C45
ICS: 11.040.40
Zuständige Behörde: Ministry of Civil Affairs
Technisches Komitee: National Technical Committee on Rehabilitation and Assistive Devices for Persons with Disabilities of Standardization Administration of China

Normbeziehungen

Ersetzt:GB 22457-2008 (Gültig)