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YY/T 2007-2026Cardiovascular implants - Embolic microspheres (English PDF)

心血管植入器械栓塞微球

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 9, 2026

Implementation date

March 1, 2027

Scope

YY/T 2007-2026 is the English-translated version of 心血管植入器械栓塞微球.

YY/T 2007 is the product standard for the microspheres injected to block a blood vessel, the workhorse of tumour embolisation and of bleeding control.

It specifies the general requirements for embolic microspheres together with their marking, packaging, transport and storage, describes the corresponding test methods, and outlines how the design is verified and validated through risk management: the appropriate tests are selected by risk assessment, and they cover the physical, chemical and biological performance of the microspheres.

It applies to microspheres whose function in vascular embolisation is to occlude, and it explicitly excludes radioactive embolic microspheres and non-spherical embolic particles.

For a manufacturer of bland or drug-eluting embolic beads seeking registration in China, this is the standard the specification and the test plan are built on.

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Document preview — YY/T 2007-2026

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C45

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions

Foreword

This document was issued on 9 March 2026 by the National Medical Products Administration and takes effect on 1 March 2027.

It is a YY/T standard: it is recommended rather than compulsory, but it is the method a Chinese reviewer applies when assessing a registration submission.

It is classified under ICS 11.040.40, Chinese classification C45.

1 Scope

YY/T 2007 is the product standard for the microspheres injected to block a blood vessel, the workhorse of tumour embolisation and of bleeding control. It specifies the general requirements for embolic microspheres together with their marking, packaging, transport and storage, describes the corresponding test methods, and outlines how the design is verified and validated through risk management: the appropriate tests are selected by risk assessment, and they cover the physical, chemical and biological performance of the microspheres. It applies to microspheres whose function in vascular embolisation is to occlude, and it explicitly excludes radioactive embolic microspheres and non-spherical embolic particles. For a manufacturer of bland or drug-eluting embolic beads seeking registration in China, this is the standard the specification and the test plan are built on.

Remaining clauses in the full document

2 Normative references
3 Terms and definitions

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Similar standards

YY/T 1680|YY/T 1561|YY/T 1571|YY/T 1274|YY/T 1925

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