National Standard of the P.R.C., Cardiopulmonary bypass systems-Roller blood pump G/TBT/N/CHN/2132

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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): Roller blood pump of cardiopulmonary bypass systems (HS code(s): 901890); (ICS code(s): 11.040.40)

5.

Details of notified document(s) (title, number of pages and languages, means of access): National Standard of the P.R.C., Cardiopulmonary bypass systems-Roller blood pump; (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, modes, compositions, basic parameters, requirements, test methods for cardiopulmonary bypass system-roller blood pump.

This document applies to cardiopulmonary bypass system-roller blood pump, which is used by medical organization to temporarily replace heart function for cardiopulmonary bypass or regional perfusion during surgery or emergency treatment.

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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

10.

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