YY 0948-2025Cardiopulmonary bypass systems - Arteriovenous cannula for single use (English PDF)

YY 0948-2025 is the English-translated version of 心肺转流系统 一次性使用动静脉插管.

YY 0948 is the mandatory standard for the single-use arteriovenous cannula in a cardiopulmonary bypass circuit, the tube that takes blood out of the patient and returns it during open heart surgery. As a YY standard without the /T suffix, compliance in China is compulsory. The cannula is the part of the bypass circuit in direct contact with the great vessels and under full pump pressure, so its dimensional accuracy, kink and burst behaviour, connection security and blood contact properties are what the standard has to fix. The 2025 edition takes effect on 1 July 2028, a three-year transition consistent with the other mandatory implant and circuit standards issued that day. For a manufacturer or an importer of bypass cannulae selling into China, this is the governing document.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 27 pages — is available in the English PDF.

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