T/GDMDMA 0056-2026 Active Group standards

T/GDMDMA 0056-2026 Rapamycin-coated balloon catheter

Publish Date: 1970-01-01 Implement Date: 1970-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Price: $ 43.00

Out of stock

Basic Information

Standard Code: T/GDMDMA 0056-2026

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical hygiene products

ICS Name: Blood transfusion, infusion, and injection equipment

Publish Date: 1970-01-01

Implement Date: 1970-01-01

Scope

This document defines the terms and definitions of rapamycin drug-coated balloon dilatation catheters (hereinafter referred to as balloon catheters), stipulates the basic requirements, and describes the corresponding test methods. This document applies to rapamycin drug-coated balloon dilatation catheters used in percutaneous transluminal angioplasty. (1) Appearance (2) Dimensions (3) Catheter hub (4) Detectability (5) Corrosion resistance (6) Peak tensile strength (7) Balloon rated burst pressure (8) Balloon fatigue (9) Balloon pressure relief time (10) Relationship between balloon diameter and inflation pressure (balloon compliance) (11) No leakage (12) Balloon removal (13) Rapamycin drug-coating performance (14) Chemical properties (15) Ethylene oxide residue (16) Sterility (17) Bacterial endotoxins