GB12260-2017

Cardiopulmonary bypass systems—Roller blood pump

心肺转流系统滚压式血泵

GB 12260-2017 é uma norma nacional chinesa obrigatória vigente: Cardiopulmonary bypass systems—Roller blood pump. Setor: Alimentos. Foco: Segurança de produtos. Entrada em vigor: 1 de jul. de 2019.

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 cardiopulmonary bypass systems specifically utilizing roller blood pumps. It is designed for medical facilities performing surgeries or emergency rescues where the pump temporarily replaces heart function for extracorporeal circulation or local perfusion. Compliance with this standard is mandatory for all manufacturers of these specific medical devices. It does not apply to other types of blood pumps or cardiopulmonary bypass equipment outside the roller pump category.

Requisitos técnicos

The standard outlines comprehensive performance and safety parameters for roller blood pumps. It specifies requirements for both constant flow and pulsatile flow operations, including flow rate tolerances, maximum flow capacities, and rotational speed accuracy. Manufacturers must ensure that their pumps meet the strict performance metrics for both operational modes. Mechanical integrity is heavily emphasized, with specific requirements for roller radial runout, synchronization errors between rollers, and coaxiality between the central axis and the pump body. The standard also mandates specific safety monitoring functions, including pressure, temperature, and time monitoring, as well as critical bubble detection and blood level detection capabilities to automatically halt operation during adverse events. Environmental adaptability and electrical safety are also covered. The equipment must withstand specific climate and mechanical environmental tests as referenced in GB/T 14710-2009, and must comply with the general safety requirements for medical electrical equipment outlined in GB 9706.1 and GB 9706.15. Proper noise level limitations and structural integrity under normal working conditions are also strictly enforced.

Métodos de ensaio

Testing procedures involve visual inspections for structural integrity and utilizing precision instruments like dial indicators to measure mechanical tolerances such as roller runout and synchronization errors. Flow and speed accuracy are tested using water as a blood substitute under specific pressure conditions. Safety features are evaluated by simulating critical conditions, such as injecting specific volumes of air for bubble detection or manipulating blood levels for automatic pump halt testing. Noise levels are measured using an A-weighted sound level meter at a specified distance from the pump head.

Perguntas frequentes

What products are regulated under GB 12260-2017?

GB 12260-2017 specifically regulates cardiopulmonary bypass systems that utilize roller blood pumps used for extracorporeal circulation or local perfusion during surgeries.

Is GB 12260-2017 a mandatory standard?

Yes, all technical content within GB 12260-2017 is mandatory for manufacturers producing roller blood pumps for the Chinese market.

What are the key safety monitoring requirements in this standard?

The standard requires pumps to have pressure monitoring, temperature monitoring, at least three timers, bubble detection (for bubbles >0.065mL), and blood level monitoring with automatic pump stop functions.

The summary above provides a high-level overview of GB 12260-2017. 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 12260-2017 today to access all detailed parameters, tables, and testing procedures.

Indicações de aplicabilidade

Tipo: Produto
CCS: C45
ICS: 11.040.40
Órgão competente: National Medical Products Administration
Comitê técnico: National Technical Committee on Medical Extracorporeal Circulation Equipment of Standardization Administration of China

Relações

Substitui:GB 12260-2005