GB12263-2017

Cardiopulmonary bypass systems—Water heating/cooling system

心肺转流系统热交换水箱

GB 12263-2017 est une norme nationale chinoise obligatoire en vigueur : Cardiopulmonary bypass systems—Water heating/cooling system. Secteur : Alimentation. Thème principal : Sécurité des produits. Entrée en vigueur : 1 juil. 2019.

L’applicabilité dépend du périmètre du produit, de la voie de certification, des avis des autorités et des règles de transition. Demandez une traduction ou vérifiez la source avant d’utiliser cette fiche pour une décision de conformité.

Aperçu de conformité

Cet aperçu n’est actuellement disponible qu’en anglais.

Champ d’application

This standard applies to water heating/cooling systems (water tanks) used in cardiopulmonary bypass systems. These devices provide heated, cooled, or raw water to heat exchangers in extracorporeal circulation blood systems for temperature regulation during medical perfusion. It is mandatory for manufacturers producing these specific medical devices for the Chinese market. The standard references YY/T 1145 for terminology.

Exigences techniques

The standard specifies comprehensive requirements for the performance and safety of water heating/cooling systems. Key areas include temperature control, where the range must not exceed 0°C to 42.0°C unless justified by risk management, and over-temperature protection, requiring dual independent safeguards to prevent temperatures from exceeding 42.0°C by triggering audio-visual alarms and cutting heating power. It also mandates requirements for flow rate, specifying a minimum no-load flow of 15 L/min for heat exchanger supply lines, and noise limits, restricting operational noise to a maximum of 62 dB(A) while requiring alarm sounds to be at least 65 dB(A). Furthermore, the standard outlines criteria for connection firmness, leakage prevention, and pipeline pressure protection to ensure mechanical integrity and safety. Manufacturers must comply with general safety requirements as per GB 9706.1.

Méthodes d’essai

Testing methods include visual inspection for appearance and structural integrity. Performance tests evaluate connection firmness under axial pull, flow rate measurement using volumetric and timing methods, and temperature control accuracy using calibrated thermometers. Over-temperature protection is tested by gradually heating the water to trigger alarms. Additionally, noise and alarm sound levels are measured using a sound level meter at a 1-meter distance, and leakage tests are conducted under specific pressure conditions.

Questions fréquentes

What products are regulated under GB 12263-2017?

GB 12263-2017 regulates water heating/cooling systems (water tanks) that are components of cardiopulmonary bypass systems, used to supply water to heat exchangers for blood temperature regulation during extracorporeal circulation.

Are there any updates from the previous version of GB 12263?

Yes, GB 12263-2017 replaces GB 12263-2005. Key updates include modifications to normal working conditions, appearance requirements, and flow/temperature control parameters. It also adds new requirements for temperature control, alarm sounds, and pipeline pressure.

What is the maximum temperature limit specified in GB 12263-2017?

Unless justified by a manufacturer's risk management process, the temperature control range must not exceed 0°C to 42.0°C. The standard also mandates a high-temperature alarm to prevent the water tank temperature from exceeding 42.0°C.

The summary above provides a high-level overview of GB 12263-2017. 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 12263-2017 today to access all detailed parameters, tables, and testing procedures.

Indications d’applicabilité

Type: Produit
CCS: C45
ICS: 11.040.40
Autorité compétente: National Medical Products Administration
Comité technique: National Technical Committee on Medical Extracorporeal Circulation Equipment of Standardization Administration of China

Relations

Remplace:GB 12263-2005