T/GDMES 0017-2020 Active Group standards

T/GDMES 0017-2020 Left Atrium Occluder System

Publish Date: 2020-07-03 Implement Date: 2020-07-10 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/GDMES 0017-2020

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medicine, health, and labor protection

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2020-07-03

Implement Date: 2020-07-10

Scope

Scope: The scope of application of this standard includes left atrial occluders implanted percutaneously for the prevention of ischemic stroke caused by non-valvular atrial fibrillation; Main technical content: This standard specifies the requirements for left atrial occluders based on the current level of knowledge. Regarding safety, this standard sets forth requirements in terms of expected performance, design attributes, materials, design evaluation, post-market surveillance, manufacturing, sterilization, packaging, and information provided by the manufacturer.