YY/T 2007-2026 Pending Industry standards-Medicine

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

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

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

Publisher: 国家药监局

Scope

本文件规定了栓塞微球的通用要求、标识、包装、运输和贮存，描述了相应的试验方法，概括了通过风险管理验证/确认栓塞微球的设计。通过风险评估选择适当的验证/确认试验和方法，这些试验包括评估栓塞微球的物理、化学和生物性能。本文件适用于血管栓塞术中起栓塞作用的微球。本文件不适用于放射性栓塞微球和非微球栓塞颗粒。