YY 1271-2016 Translated English of Chinese Standard. YY1271-2016: Cardiopulmonary bypass systems - Suction catheter for single usehttps://www.chinesestandard.net, 2018 M04 23 - 12 pages This standard specifies the classification and structure, requirements, test methods, markings, labels, instructions for use, packaging, transportation, and storage of sterile suction catheter for single use (hereinafter referred to as suction catheter). This standard applies to suction catheters, for supporting cardiopulmonary bypass system, suction catheter for cardiovascular ventilation in the left heart, suction decompression or reduction of left heart load, to attract the intracardiac blood and other fluids. |
Contents
| 3 | |
Scope | 4 |
Classification and structure | 5 |
Requirements | 6 |
Test methods | 8 |
Marking instruction manual | 11 |
Packaging transport storage | 12 |
Common terms and phrases
batch of blank Biological evaluation Biological properties bypass heart surgery cardiopulmonary bypass heart Cardiopulmonary bypass systems catheter for single catheter is mainly Catheter Suction head Classification and structure Color The test CONNECT the suction Connection strength Corrosion resistance document equipment for medical Ethylene oxide residue Evaporation residue exceed heart drainage tube heart suction catheter Heavy metals injection equipment Inner guiding core Joint Catheter Suction leakage free Leakage-free left heart drainage left heart load Medical devices methods for infusion methods GB/T Negative pressure tolerance number of particles Particle contamination performed in accordance period of validity pressure of 20 Production lot number provisions of GB/T Pyrogen requirements residue Test results shall comply room temperature routine control standard Sterility test sterilization GB sterilization process subject to visual suction catheter body Suction catheter schematics Temperature adaptability Test is performed Test methods test solution test Test UV absorbance Validation and routine Validity period YY/T