Standard No.:	YY 0598-2015/XG1-2018
English Name:	Concentrates for haemodialysis and related therapies, includes Amendment 1
Chinese Name:	血液透析及相关治疗用浓缩物， 含第1号修改单
Chinese Classification:	C45    Extracorporeal circulation, artificial organ and prosthesis device
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Issued by:	National Medical Products Adminstration
Issued on:	2015-03-02
Implemented on:	2018-4-11
Status:	superseded
Superseded by:	YY 0598-2015/XG2-2018 Concentrates for hemodialysis and related therapies, includes Amendment 1
Superseded on:	2018-6-14
Superseding:	YY 0598-2015 Concentrates for haemodialysis and related therapies
Language:	English
File Format:	PDF
Word Count:	11000 words
Price(USD):	330.0
Delivery:	via email in 1 business day

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