GB22457-2008

Service of fitting prosthesis

假肢配置服务

GB 22457-2008 é uma norma nacional chinesa obrigatória vigente: Service of fitting prosthesis. Setor: Alimentos. Foco: Segurança de produtos. Entrada em vigor: 1 de mar. de 2009.

A aplicabilidade depende do escopo do produto, da via de certificação, dos avisos da autoridade competente e das regras de transição. Solicite uma tradução ou verifique a fonte antes de usar este registro em uma decisão de conformidade.

Visão geral de conformidade

Esta visão geral está disponível por enquanto apenas em inglês.

Escopo e aplicabilidade

This standard is applicable to all types of institutions engaged in the assembly and fitting of prostheses. It covers the entire service process, including reception, examination, prescription, agreement signing, preparation, manufacturing, training, delivery, and follow-up. It is mandatory for all prosthetic fitting service providers operating in the Chinese market. The standard does not apply to the manufacturing of prosthetic components themselves, which are covered by separate component standards like GB 14722 and GB/T 13461.

Requisitos técnicos

The standard specifies comprehensive service requirements for prosthetic fitting, with Chapter 6 being mandatory. It mandates a first-visit responsibility system, requiring clear division of labor and signature-based accountability throughout the process. Institutions must establish an internal quality management system and ensure their personnel, facilities, and environments meet specific operational standards. Key requirements include detailed patient reception and medical record-keeping, with records and fitting agreements required to be preserved for at least 15 years. The fitting process must follow strict procedures for measurement, modeling, and alignment. A formal prosthetic prescription must be issued, detailing the prosthesis type, components, and materials, and must be signed by the patient or their family. The standard outlines rigorous quality inspection protocols, requiring both initial and final adaptability evaluations. Initial checks assess correct wearing, socket fit, and alignment, while final checks verify compliance with the prescription, safety, and appearance. Upon delivery, institutions must provide a certificate of conformity, warranty card, and instruction manual. Institutions must respond to patient inquiries within 48 hours and conduct regular follow-ups, typically at 3-month, 6-month, or 1-year intervals.

Métodos de ensaio

The standard outlines specific evaluation procedures rather than traditional laboratory tests. Key assessments include the initial adaptability evaluation (checking socket fit, alignment, joint range of motion, and suspension) and the final adaptability evaluation (verifying prescription compliance, safety, and cosmetic appearance). For lower limb prostheses, dynamic walking and sitting checks are mandatory. Dimensional measurements must be conducted according to the referenced component standards, utilizing the detailed measurement forms provided in the normative appendices.

Perguntas frequentes

What institutions are regulated under GB 22457-2008?

GB 22457-2008 applies to all types of institutions and facilities engaged in the assembly and fitting of prostheses in China, including rehabilitation centers and specialized prosthetic fitting companies.

Is GB 22457-2008 a mandatory standard?

Yes, while the standard is mostly recommended, Chapter 6 (General Requirements for Prosthesis Fitting) is mandatory. This chapter covers the core service流程 from reception to delivery and follow-up.

How long must patient records be kept according to GB 22457-2008?

The standard requires that prosthetic medical records and fitting agreements must be preserved for at least 15 years by the fitting institution.

The summary above provides a high-level overview of GB 22457-2008. To ensure complete compliance for your prosthetic 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 22457-2008 today to access all detailed parameters, mandatory procedures, and normative appendices.

Indicações de aplicabilidade

Tipo: Segurança
CCS: C45
ICS: 11.040.40
Órgão competente: Ministry of Civil Affairs
Comitê técnico: National Technical Committee on Rehabilitation and Assistive Devices for Persons with Disabilities of Standardization Administration of China

Relações

Substituída por:GB 22457-2025 (Futura)