1 Scope
This standard specifies the chemical composition, purity, microbial contamination, handling, measuring, labelling, requirements for container and various tests required for quality inspection of the concentrates.
This standard is applicable to the concentrates for haemodialysis and related therapies.
This standard is not applicable to the mixing process in which concentrate and dialysis water are formulated to a final working concentration during therapy.
This standard is not applicable to the regeneration system of dialysis fluid.
2 Normative References
The following documents for the application of this document are essential. For dated references, only the edition cited applies. For undated reference, the latest edition (including all the amendments) applies.
GB/T 13074-2009 Terms of Blood Purification
YY 0572 Water for Haemodialysis and Related Therapies (YY 0572-2015, ISO 13959:2009, MOD)
ISO 11663:2009 Quality of Dialysis Fluid for Haemodialysis and Related Therapies (MOD)
WS-10001-(HD-0476)-2002 Magnesium Chloride
Pharmacopoeia of the People’s Republic of China (2015 Edition)
3 Terms and Definitions
For the purposes of this document, the terms and definitions established in GB/T 13074-2009 and the following ones apply.
3.1
acetate concentrate
mixture of salts containing acetate, which when diluted with dialysis water, yields bicarbonate-free dialysis fluid for use in dialysis
Note 1: Acetate concentrate might contain glucose.
Foreword II
1 Scope
2 Normative References
3 Terms and Definitions
4 Materials
5 Requirements
6 Test Methods
7 Labelling
Annex A (Informative) Main Technical Differences between This Standard and YY 0598-2006 and the Relevant Reasons
Annex B (Informative) Main Technical Differences between This Standard and ISO 13958:2009 and the Relevant Reasons
Annex C (Informative) Equipment and Other Related Requirements
Bibliography
