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This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0598-2006 Concentrates for Haemodialysis and Related Therapies; in addition to editorial changes, the main technical differences made with respect to YY 0598-2006 are listed in Annex A.
This standard is modified in relation to ISO 13958:2009 Concentrates for Haemodialysis and Related Therapies. The technical differences between this standard and ISO 13958:2009 are listed in Annex B.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the China Food and Drug Administration.
This standard is under the jurisdiction of National Technical Committee on Extracorporeal Circuit Equipment of Standardization Administration of China (SAC/TC 158).
This standard was issued in 2006 for the first time and was revised in 2015 for the first time.
Concentrates for Haemodialysis and Related Therapies
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.
Note 2: Sodium acetate is used to provide a buffer in place of sodium bicarbonate.
Note 3: Acetate concentrate is generally used as a single concentrate.
3.2
acid concentrate
A-concentrate
acidified concentrated mixture of salts that, when diluted with dialysis water and bicarbonate concentrate, yields dialysis fluid for use in dialysis
Note 1: The term “acid” refers to the small amount of acid (usually acetic acid) that is included in the concentrate.
Note 2: Acid concentrate might contain glucose.
Note 3: Acid concentrate can be in the form of a liquid, a dry powder or a combination of the two.
3.3
batch system
apparatus in which the dialysis fluid is prepared in bulk before each dialysis session
3.4
bicarbonate concentrate
B-concentrate
concentrated preparation of sodium bicarbonate that, when diluted with dialysis water and acid concentrate, makes dialysis fluid used for dialysis
Note 1: Some bicarbonate concentrates also contain sodium chloride.
Note 2: Bicarbonate concentrate can be in the form of a liquid or a dry powder.
Note 3: Dry sodium bicarbonate, without added sodium chloride, is also used in concentrate generators to produce a saturated solution of sodium bicarbonate used by the dialysis machine to make dialysis fluid.
3.5
bulk delivery
delivery of large volume containers of liquid concentrate to a dialysis facility
Note: Bulk delivery includes containers such as drums, which can be pumped into a storage tank maintained at the dialysis facility. Alternatively the drums can be left at the facility and used to fill transfer containers to transfer the liquid concentrate to the dialysis machines. Bulk delivery can also include large containers for direct connection to a central concentrate supply system.
3.6
bulk storage tank
tank at the dialysis facility for storage of dialysis water or liquid concentrate from bulk deliveries, or for liquid concentrate prepared in bulk at the dialysis facility from powder and dialysis water
3.7
central concentrate system
system that prepares and/or stores liquid concentrate at a central point for subsequent distribution to its points of use
3.8
concentrate generator
system where the concentrate is delivered to the user as a powder in a container, suitable for attachment to the dialysis machine with which it is intended to be used, and then converted into a liquid concentrate by the dialysis machine
Note: The solution produced by the concentrate generator is used by the dialysis machine to make the final dialysis fluid delivered to the dialyser.
3.9
concentrate mixer
mixer for preparation of dialysis concentrate or dialysis fluid at a dialysis facility
3.10
dialysis fluid delivery system
device that:
1) Prepares dialysis fluid on line from dialysis water and liquid concentrate or that stores and distributes premixed dialysis fluid;
2) Circulates the dialysis fluid through the dialyser;
3) Monitors the dialysis fluid for temperature, conductivity (or equivalent), pressure, flow and blood leaks;
4) Prevents dialysis during disinfection or cleaning modes
Note 1: The term includes reservoirs, conduits, proportioning devices for the dialysis fluid, and monitors and associated alarms and controls assembled as a system for the purposes listed above.
Note 2: The dialysis fluid delivery system can be an integral part of a single-patient dialysis machine or a centralized preparation system which feeds multiple bedside monitoring systems.
Note 3: Dialysis fluid delivery systems are also known as proportioning systems and dialysis fluid supply systems.
3.11
dialysis water
water that has been treated to meet the requirements of YY 0572 and which is suitable for use in haemodialysis applications, including the preparation of dialysis fluid, reprocessing of dialysers, preparation of concentrates and preparation of substitution fluid for online convective therapies
3.12
manufacturer
entity that designs, manufactures, fabricates, assembles, formulates or processes a finished device
Note: Manufacturers include, but are not limited to, those who perform the functions of contract sterilization, installation, relabelling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions. The term does not cover preparation of liquid concentrates from prepackaged dry chemicals at a dialysis machine or the handling of bulk concentrates at a dialysis machine after responsibility for the concentrate is transferred from the manufacturer to the user.
3.13
user
physician, nurse or relevant engineering technician responsible for the actual production and handling of dialysis fluid in medical institution
Note: This standard is mainly directed to device manufacturers, and in that context the “user” is as noted above.
4 Materials
4.1 Containers
The contents of the containers (including the closures) shall not affect the concentration limits and other technical requirements specified in 5.2 during handling, storage and shipment. The volume of each container shall not be less than the labelled volume of the volume or mass of the concentrate contained. Containers and closures shall be capable of maintaining the microbiological conditions.
4.2 Chemical raw materials
All chemical raw materials shall meet the requirements of the following standards, and shall be inspected batch by batch when being delivered to the factory.
4.2.1 Sodium chloride (NaCl)
It shall comply with the relevant provisions on sodium chloride in the Pharmacopoeia of the People’s Republic of China (2015 Edition).
4.2.2 Calcium chloride (CaCl2·2H2O)
It shall comply with the relevant provisions on calcium chloride in the Pharmacopoeia of the People’s Republic of China (2015 Edition).
4.2.3 Potassium chloride (KCl)
It shall comply with the relevant provisions on potassium chloride in the Pharmacopoeia of the People’s Republic of China (2015 Edition).
4.2.4 Magnesium chloride (MgCl2·6H2O)
It shall comply with the relevant provisions on magnesium chloride in WS-10001-(HD-0476)-2002.
4.2.5 Sodium acetate (CH3 COONa·3H2O)
It shall comply with the relevant provisions on sodium acetate in the Pharmacopoeia of the People’s Republic of China (2015 Edition).
4.2.6 Anhydrous glucose (C6H12O6)
It shall comply with the relevant provisions on anhydrous glucose in the Pharmacopoeia of the People’s Republic of China (2015 Edition).
4.2.7 Glucose (C6H12O6·H2O)
It shall comply with the relevant provisions on glucose in the Pharmacopoeia of the People’s Republic of China (2015 Edition).
4.2.8 Sodium bicarbonate (NaHCO3)
It shall comply with the relevant provisions on sodium bicarbonate (for haemodialysis) in the Pharmacopoeia of the People’s Republic of China (2015 Edition).
4.2.9 Glacial acetic acid (C2H4O2)
It shall comply with the relevant provisions on glacial acetic acid in the Pharmacopoeia of the People’s Republic of China (2015 Edition).
4.2.10 Acetic acid (C2H4O2)
It shall comply with the relevant provisions on acetic acid in the Pharmacopoeia of the People’s Republic of China (2015 Edition).
4.2.11 Other materials
They shall comply with the current technical requirements of the Pharmacopoeia of the People’s Republic of China (2015 Edition) and national drug standards, including all applicable provisions as well as the applicable test methods in the annex of Pharmacopoeia of the People’s Republic of China (2015 Edition) and those in national drug standards.
4.3 Water
The quality of water used in the preparation of the liquid concentrate shall be in accordance with YY 0572.
5 Requirements
5.1 State
Liquid concentrate or that prepared from dry powder shall be free of visible foreign matter and shall not be darker than No.1 yellow (or yellow-green) colorimetric solution.
5.2 Solute concentrations
During the shelf life, the concentration of sodium ions shall be 97.5% to 102.5% of the labelled amount, and the concentration of other solutes shall be 95.0% to 105.0% of the labeled amount.
5.3 Microbial limits
For the liquid concentrate (or that prepared from dry powder in use proportion) containing bicarbonate, the total count of bacteria in it shall be no more than 100 CFU/mL and that of fungi shall be no more than 10 CFU/mL, while Escherichia coli shall not be detected.
Note: There is no literature reporting that acid concentrate supports bacterial growth, and this clause is not applicable to acid concentrate.
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
