YY 0054-2010: Translated English of Chinese Standard. YY0054-2010: Haemodialysis equipment
https://www.chinesestandard.net, 2016 M03 4 - 33 pages
This Standard specifies haemodialysis equipment terms and definitions, classifications and basic parameters, requirements, test methods, inspection rules, marks, instructions for use, packaging, transport, as well as storage requirements.
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Terms and definitions
Marks instructions for use packaging transport and storage
according to requirements Adjust air detector alarm action alarm limit amount of dehydration arithmetic mean atmospheric pressure blood pump Check valve chemical disinfection Concentration control Conduct test Degassing device Dialysate composition dialysate line dialysate temperature electronic balance endotoxin Environmental test equipment is stable equipment shall comply error shall meet Exit-factory inspection extracorporeal blood line following provisions following requirements GB/T hemodiafiltration hemodialysis mode hemofiltration Heparin flow heparin injection indication precision inlet inspection items liquid level low limit alarm manufacturer manufacturer's instructions manufacturer’s maximum dialysate flow maximum error meet requirements milliliters mL/h mmHg monitoring test according negative pressure nominal range Note 3 Note precision is better pressure monitoring test puncture needle requirements in 5.10 requirements in 5.5.2 Respectively set results shall meet send out alarm Set dialysate flow set value stopwatch substitution fluid flow technical documents Temperature control precision test methods test Note transmembrane pressure type test ultrafiltration rate