GB14722-2008

Modular hip disarticulation prosthesis, Modular knee disarticulation prosthesis and modular above knee prosthesis

组件式髋部、膝部和大腿假肢

GB 14722-2008 es una norma nacional china obligatoria vigente: Modular hip disarticulation prosthesis, Modular knee disarticulation prosthesis and modular above knee prosthesis. Sector: Alimentos. Enfoque: Seguridad de productos. Entrada en vigor: 1 mar 2009.

La aplicabilidad depende del alcance del producto, la vía de certificación, los avisos de la autoridad competente y las reglas de transición. Solicite una traducción o verifique la fuente antes de usar esta ficha en una decisión de cumplimiento.

Resumen de cumplimiento

Este resumen está disponible por ahora solo en inglés.

Alcance y aplicabilidad

This standard applies to the design, manufacturing, assembly, and acceptance of modular hip disarticulation prostheses, modular knee disarticulation prostheses, and modular above-knee prostheses. It is specifically targeted at prosthetic devices used by amputees with amputations at or above the knee level. Manufacturers and assemblers of these lower limb prosthetic components must comply with this standard.

Requisitos técnicos

Chapter 5 of this standard is mandatory and specifies comprehensive technical requirements for the prosthetic system. It mandates the completion of technical files, including prosthetic medical records and measurement tables, in accordance with GB/T 10000. The standard defines structural compositions for different prosthesis types and requires components to meet GB 14723 standards. The standard details specific requirements for various components, including acceptance sockets (categorized into pelvic containment, quadrilateral, ischial containment, and knee-bearing types), soft liners, and silicone liners. It also specifies criteria for hip joints, knee joints (including intelligent and hydraulic variants), ankle joints, and prosthetic feet (including energy-storing types). Materials used for sockets and liners must be non-toxic, non-irritating, and meet specific physical-mechanical performance thresholds. Additional requirements cover connection methods, suspension systems, and alignment procedures (bench, static, and dynamic). The standard also sets limits on the overall dimensions and mass of the prostheses; for instance, the mass of an above-knee prosthesis should not exceed 3.5 kg. Manufacturers must ensure that metal components and prosthetic feet comply with the structural strength requirements specified in GB/T 18375.

Métodos de ensayo

Testing methods involve measuring internal dimensions and depths of sockets using specialized tools like internal circumference measurers and depth gauges. Physical and mechanical properties of materials are verified by preparing standard test specimens. Alignment inspections are conducted on alignment platforms and through dynamic gait observation. Additionally, the overall dimensions, mass, and appearance of the assembled prosthesis are verified against the specified tolerances.

Preguntas frecuentes

What products are regulated under GB 14722-2008?

The standard regulates modular hip disarticulation prostheses, modular knee disarticulation prostheses, and modular above-knee prostheses. It applies to the design, manufacturing, assembly, and acceptance of these specific lower limb prosthetic devices.

Are there any updates from the previous version of GB 14722-2008?

Yes, compared to the previous version (GB 14722-1993), this standard changed its name and added technical requirements for new products and technologies, such as intelligent prosthetic knee joints, energy-storing feet, and silicone liners.

How does GB 14722-2008 relate to other prosthetic standards?

The standard references several national standards for general components and structural testing, such as GB 14723 and GB/T 18375. Manufacturers must ensure that metal components and prosthetic feet comply with the structural testing provisions outlined in these referenced standards.

The summary above provides a high-level overview of GB 14722-2008. To ensure complete compliance for your products entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 14722-2008 today to access all detailed parameters, measurement tables, and testing procedures.

Indicaciones de aplicabilidad

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

Relaciones

Sustituye a:GB 14722-1993