GB2024-2016

Acupuncture needles

针灸针

GB 2024-2016 é uma norma nacional chinesa obrigatória vigente: Acupuncture needles. Setor: Alimentos. Foco: Segurança de produtos. Entrada em vigor: 1 de jul. de 2018.

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

GB 2024-2016 applies to acupuncture needles used in acupuncture therapy, covering both non-sterile acupuncture needles and single-use sterile acupuncture needles. This standard is mandatory for all manufacturers producing these medical devices for the Chinese market. It specifically regulates various handle types, including ring handle, flat handle, plastic handle, and metal tube handle needles.

Requisitos técnicos

This standard specifies the physical and mechanical requirements for acupuncture needles, including basic dimensions for needle body diameter and length, as well as handle length. It mandates strict hardness limits for the needle body to ensure clinical durability and performance. Manufacturers must adhere to these dimensional and hardness tolerances to achieve compliance. The standard outlines critical performance criteria such as needle tip performance, requiring the tip to be round, straight, and free of burrs or hooks, with specific limits on puncture force. It also specifies toughness, surface quality (including roughness), and the connection firmness between the needle body and handle. Needles must withstand specified axial tensile forces without significant displacement. Additionally, the standard addresses corrosion resistance and biocompatibility. For single-use sterile needles, a validated sterilization process is mandatory, and packaging must maintain sterility. Materials must undergo biological evaluation according to GB/T 16886.1 to ensure safety.

Métodos de ensaio

The standard mandates specific testing methods, including Vickers hardness testing according to GB/T 4340.1 and tensile testing for handle connection firmness. Needle tip strength and sharpness are evaluated using a dedicated tester with aluminum foil. Other key tests include toughness winding tests, surface roughness inspection, and corrosion resistance testing using a citric acid solution method.

Perguntas frequentes

What products are regulated under GB 2024-2016?

GB 2024-2016 is a mandatory national standard for all acupuncture needles manufactured or sold in China. It applies to both non-sterile acupuncture needles and single-use sterile acupuncture needles used in acupuncture therapy.

Are there any updates from the previous version of GB 2024-2016?

Compared to the previous GB 2024-1994, the 2016 version introduces plastic handles and metal tube handles. It also modifies the hardness requirements by setting an upper limit, adds regulations on lubricant accumulation, and introduces new packaging and inspection rules.

How does GB 2024-2016 differ from ISO standards?

GB 2024-2016 aligns with several international standards, referencing ISO 6507-1 for Vickers hardness testing and ISO 10993-1 for biological evaluation. However, it includes specific Chinese national requirements for needle tip strength and sharpness testing using aluminum foil, which may differ from general ISO guidelines.

The summary above provides a high-level overview of GB 2024-2016. 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 2024-2016 today to access all detailed parameters, tables, and testing procedures.

Indicações de aplicabilidade

Tipo: Produto
CCS: C31
ICS: 11.040.99
Órgão competente: National Medical Products Administration
Comitê técnico: National Technical Committee on Medical Syringes and Needles of Standardization Administration of China

Relações

Substitui:GB 2024-1994