YY/T 2007-2026 Pending Industry standards-Medicine

YY/T 2007-2026 Cardiovascular Implantable Device with Embolic Microsphere。

YY/T 2007-2026 Cardiovascular implants—Embolic microspheres

Publish Date: 2026-03-09 Implement Date: 2027-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Price: $ 31.00

Out of stock

Basic Information

Standard Code: YY/T 2007-2026

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2026-03-09

Implement Date: 2027-03-01

Pages: 16 pages

Scope

This document specifies the general requirements, marking, packaging, transportation, and storage of embolization microspheres, describes the corresponding test methods, and summarizes the design validation/confirmation of embolization microspheres through risk management. Appropriate validation/confirmation tests and methods are selected through risk assessment, which include evaluating the physical, chemical, and biological properties of embolization microspheres. This document applies to microspheres that play an embolization role in vascular embolization. This document does not apply to radioactive embolization microspheres and non-microspheral embolization particles.