GB14723-2008

Modular units of the lower limb prosthesis

下肢假肢通用件

GB 14723-2008 é uma norma nacional chinesa obrigatória vigente: Modular units of the lower limb 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 applies to modular units of lower limb prostheses used by lower limb amputees. It covers various general components including prosthetic feet, ankle joints, knee joints, hip joints, connectors, and external cosmetic parts. It is applicable to manufacturers and suppliers of prosthetic components entering the Chinese medical device and rehabilitation market. The standard specifically includes newer materials and products such as energy-storing feet, intelligent knee joints, and silicone liners.

Requisitos técnicos

Chapter 6 of this standard contains the mandatory technical requirements. It specifies that components must be manufactured according to design documents and outlines specific performance criteria for different part categories. For foot and ankle components, the standard mandates impact absorption capabilities and specific deformation limits for plantar flexion and dorsiflexion, categorized into soft (S) and hard (H) specifications. For knee and hip joints, the standard requires smooth flexion and extension, stating that the minimum flexion angle must not exceed 70°. Connectors must feature specific alignment adjustment ranges, including horizontal translation and angular rotation capabilities. Materials used must be non-toxic, moisture-proof, and possess high specific strength to withstand required structural tests. Furthermore, all load-bearing components must pass structural strength tests without cracks, damage, or permanent deformation. The standard also defines strict appearance requirements for surfaces, ensuring plastic, leather, and plated parts are free from defects like scratches, bubbles, or peeling.

Métodos de ensaio

The standard outlines specific testing procedures to verify compliance. This includes applying a vertical load of 400N to measure foot and ankle deformation, and using specific torque values (e.g., 20N·m and 50N·m) to measure rotation and inversion/eversion angles. Structural strength testing must be conducted in accordance with GB/T 18375. Visual inspection is also required for appearance evaluation.

Perguntas frequentes

What products are regulated under GB 14723-2008?

The standard regulates various lower limb prosthesis components, including prosthetic feet, ankle joints, knee joints, hip joints, connectors, and cosmetic shells. It also covers newer technologies like energy-storing feet and intelligent knee joints.

Are there any mandatory clauses in GB 14723-2008?

Yes, Chapter 6 of GB 14723-2008 contains mandatory technical requirements. Manufacturers must strictly adhere to these structural strength, material, and performance requirements. Other chapters are recommended.

How does GB 14723-2008 relate to ISO standards?

The standard references GB/T 18375 for structural strength testing, which is identical to ISO 10328. This ensures alignment with international testing protocols for structural integrity. However, GB 14723-2008 includes specific national requirements for dimensions and performance.

The summary above provides a high-level overview of GB 14723-2008. 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 14723-2008 today to access all detailed parameter tables, dimensional schematics, and testing procedures.

Indicações de aplicabilidade

Tipo: Produto
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

Substitui:GB 14723-1993