YY 0572-2015Water for haemodialysis and related therapies (English PDF)
血液透析及相关治疗用水
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
March 2, 2015
Implementation date
January 1, 2017
Scope
YY 0572-2015 is the English-translated version of 血液透析及相关治疗用水.
YY 0572-2015 is the Chinese standard that sets the minimum requirements for the water used in haemodialysis and related therapies: the water from which concentrate and dialysate are prepared for haemodialysis, haemodiafiltration and on-line haemofiltration, and the water used to reprocess dialysers.
It fixes the chemical contaminants and their maximum concentrations, the microbiological limits for bacteria and endotoxin, and the monitoring that keeps the water within them.
It does not deal with the operation of the water treatment plant, nor with the preparation of dialysate from treated water and concentrate, which are the work of trained dialysis staff, and it does not apply to dialysate regeneration systems.
It replaces YY 0572-2005, was issued on 2 March 2015 and has applied since 1 January 2017.
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Document preview — YY 0572-2015
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C 45
- Replacing
- YY 0572-2005
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard replaces YY 0572-2005 "water for hemodialysis and related therapies." The main technical differences YY 0572-2005 as follows.
--- Increase the total chlorine, antimony, beryllium, thallium four kinds of chemical pollutants maximum permissible quantity requirements;
--- Improving endotoxin requirements;
--- Deletion of chloramines, chlorine, tin and other three chemical pollutants maximum permissible quantity requirements;
--- Added Appendix A (informative), Annex B (informative).
This revised standard adopts the International Standard ISO 13959:2009 "hemodialysis and related water treatment." This standard and ISO 13959. Compared to 2009, the main differences are as follows.
--- Terms and definitions have been deleted in GB/T 13074-2009 defined;
--- Added Appendix B (informative);
--- Relevant technical requirements and test methods have changed.
1 Scope
This standard specifies the hemodialysis, hemodiafiltration and online (on-line) or online hemofiltration (on-line) hemodiafiltration Preparation of dialysate concentrate and dialysate and blood dialyzer reprocessing the minimum requirements of the water used.
This standard does not address the operation of water treatment equipment, nor is there any dialysate from the treated water with the concentrate blend for use in medical treatment. This These operations only by specialized dialysis personnel responsible for the operation. This standard does not apply to the dialysate regeneration system.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 13074-2009 blood purification term People's Republic of China Pharmacopoeia (two) (2010 Edition)
3 Terms and Definitions
GB/T 13074 and defined by the following terms and definitions apply to this document.
3.1 Intervention level actionlevel
The concentration of pollutants, to intervene to block its rise to unacceptable levels when the concentration should be reached.
3.2 Total chlorine
The sum of free chlorine and combined chlorine.
NOTE. The main chlorine in water in a dissolved molecular chlorine (chlorine free) or chemical form (bound chlorine) form. The main ingredient is combined with chlorine chloramine, used In water disinfection.
3.3 Dialysis water
Meet the requirements of this standard and are suitable for use in hemodialysis water, including water reprocessing dialysate preparation water, dialyzer, through Preparation of water analysis and online replacement fluid concentrate preparation water.
4 Requirements
4.1 Microbiological requirements
Total number of bacteria in the dialysis water should not exceed 100CFU/mL, intervention levels should be based on knowledge of the system dynamics of microorganisms.
Typically, the intervention level is the maximum allowable level of 50%.
Endotoxin content in the dialysis water should not exceed 0.25EU/mL. Intervention level must be established, in general, is the maximum allowable levels 50%.
Note. See A.1, about the history of these requirements.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.
Referenced standards
Similar standards
Editions of YY 0572
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 0572-2015 | Water for haemodialysis and related therapies | current edition | Current |
| YY 0572-2005 | Water for haemodialysis and related therapies | previous edition | Superseded |
This page sells the current edition, YY 0572-2015. Earlier editions are listed for reference only.
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