National Standard of the P.R.C., Cardiopulmonary bypass systems Water Heating/Cooling System G/TBT/N/CHN/2134

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Notifying Member: CHINA

If applicable, name of local government involved (Articles 3.2 and 7.2):

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Agency responsible:

State Administration for Market Regulation (Standardization Administration of the P.R.C.)

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Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ],3.2 [ ], 7.2 [ ],Other:

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Products covered (HS codes or national tariff lines. ICS numbers may be provided in addition, where applicable): Water heating/cooling system for cardiopulmonary bypass systems (HS code(s): 901890); (ICS code(s): 11.040.40)

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Details of notified document(s) (title, number of pages and languages, means of access): National Standard of the P.R.C., Cardiopulmonary bypass systems Water Heating/Cooling System; (10 page(s), in Chinese)

Link to notified document(s) and/or contact details for agency or authority which can provide copies upon request:

6.

Description of content: This document specifies the terms and definitions, requirements, and test methods for the water heating/cooling system of cardiopulmonary bypass systems.

This document applies to the water heating/cooling system of cardiopulmonary bypass systems (hereinafter referred to as the "heater-cooler device"), which serves as the driving device that provides heated water, cooled water, and raw water to the heat exchanger in the cardiopulmonary bypass blood heat exchange system, for temperature regulation during cardiopulmonary bypass perfusion in medical institutions.

This document applies to:

—Heater-cooler device for extracorporeal membrane oxygenation (ECMO)(hereinafter referred to as the "ECMO heater-cooler device"); and

—Heater-cooler device for cardiopulmonary bypass (CPB) (hereinafter referred to as the "CPB heater-cooler device").

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Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety; Quality requirements

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Relevant documents:

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9.

Proposed date of adoption: To be determined

Proposed date of entry into force: 36 months after adoption

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Provision of comments

Final date for comments: 10 January 2026

[X] 60 days from notification

Contact details of agency or authority designated to handle comments regarding the notification:

WTO/TBT National Notification and Enquiry Center of the People's Republic of China

Tel：+86 10 57954633/ 57954627

E_mail: tbt@customs.gov.cn