GB3053-1993

Sphygmomanometer

血压计和血压表

GB 3053-1993 é uma norma nacional chinesa obrigatória vigente: Sphygmomanometer. Setor: Eletrônicos. Foco: Segurança elétrica. Entrada em vigor: 1 de jun. de 1994.

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 mercury sphygmomanometers and mechanical elastic element sphygmomanometers used for measuring human blood pressure. It explicitly covers various structural forms including desktop, vertical, and wall-mounted types. This standard is not applicable to electronic blood pressure monitors, making it crucial for manufacturers of traditional mechanical and mercury-based medical devices to ensure compliance.

Requisitos técnicos

The standard specifies comprehensive physical and metrological requirements for blood pressure devices. It mandates a dual-scale system utilizing both kilopascals (kPa) and millimeters of mercury (mmHg), with strict regulations on the minimum division values. Manufacturers must ensure zero-position accuracy and strict basic error limits to guarantee measurement precision. Structural integrity is heavily emphasized, requiring robust casing and reliable component connections. For mercury sphygmomanometers, specific mandates include using No. 1 mercury as referenced in GB 913, utilizing mercury-resistant materials for contact parts, and incorporating effective mercury stoppers. Devices must demonstrate absolute prevention of mercury leakage and excellent air tightness during operation. Additional requirements cover the durability of components such as rubber bulbs, bags, and cuffs, specifying dimensional tolerances and secure fastening mechanisms. For mechanical sphygmomanometers, the standard dictates vibration resistance, pointer stability, and the ability to withstand 15,000 cycles of variable pressure testing. Surface treatments, including electroplating and paint coatings, must meet the classifications outlined in YY 0076 and ZB C30 003.1.

Métodos de ensaio

Testing protocols include zero-position verification, dual-pressure reduction comparison tests for indication accuracy, and air tightness evaluations under sustained pressure. Specialized assessments are defined for cuff security, mercury leakage, and pointer stability. Devices must undergo rigorous endurance and transportation testing, including variable pressure cycle tests and continuous impact or simulated vehicle transport tests to ensure structural resilience.

Perguntas frequentes

What products are regulated under GB 3053-1993?

This standard specifically regulates mercury sphygmomanometers and mechanical elastic element sphygmomanometers. It explicitly excludes electronic blood pressure monitors, which are governed by separate standards.

Are there any updates from the previous version of GB 3053?

GB 3053-1993 consolidated and replaced several older standards, including GB 3053-82, GB 4727-84, and GB 8049-87. It also invalidated the professional standard ZB C38 001-87 for vertical sphygmomanometers upon implementation.

How does GB 3053-1993 differ from international ISO standards?

The standard incorporates specific Chinese requirements for structural integrity, mercury leak prevention, and packaging transportation tests, while referencing national standards like GB 913 for mercury purity and GB 2828 for sampling procedures.

The summary above provides a high-level overview of GB 3053-1993. To ensure complete compliance for your medical devices entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 3053-1993 today to access all detailed parameters, tables, and testing procedures.

Indicações de aplicabilidade

Tipo: Produto
CCS: C38
ICS: 71.060.20
Órgão competente: National Medical Products Administration
Comitê técnico: National Technical Committee on Medical Electrical Equipment of Standardization Administration of China

Relações

Substitui:GB 3053-1982, GB 4727-1984, GB 8049-1987