This standard specifies the general technical requirements for quality inspection of packaging materials for hemodialysis and related therapeutic concentrates, including classification and properties, requirements, test methods and markings, packaging, transportation, and storage. This standard applies to packaging materials for concentrates used in hemodialysis and related treatments. This standard does not apply to packaging materials for centrally supplied liquids and concentrates prepared by hospitals.
YY/T 1494-2016 Referenced Document
GB/T 1037 Test method for water vapor transmission of plastic film and sheet—Desiccant method and water method*, 2021-11-26 Update
GB/T 1038 Plastics-Film and sheeting-Determination of gas transmission-Differential-pressure method
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use.Part 1:Chemical analysis methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use.Part 2:Biological test methods
GB/T 5750.6-2006 Standard examination methods for drinking water Metal parameters
YY 0598 Concentrates for haemodialysis and related therapies
YY/T 1494-2016 history
2016YY/T 1494-2016 Packaging materials for haemodialysis and related therapeutic concentrates.General requirements