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YY 0572-2015: Water for haemodialysis and related therapies
Status: Valid YY 0572: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0572-2015 | English | 299 |
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Water for haemodialysis and related therapies
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YY 0572-2015
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| YY 0572-2005 | English | 279 |
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Water for Haemodialysis and related therapies
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YY 0572-2005
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Basic data | Standard ID | YY 0572-2015 (YY0572-2015) | | Description (Translated English) | Water for haemodialysis and related therapies | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 14,140 | | Date of Issue | 2015-03-02 | | Date of Implementation | 2017-01-01 | | Older Standard (superseded by this standard) | YY 0572-2005 | | Quoted Standard | GB/T 13074-2009 | | Adopted Standard | ISO 13959-2009, MOD | | Regulation (derived from) | The State Food and Drug Administration Announcement 2015 No. 8 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard specifies the minimum hemodialysis, hemodiafiltration and online (on-line) hemofiltration or online (on-line) hemodiafiltration dialysis concentrates and prepared dialysis fluid and blood dialyzer reprocessing the water Claim. 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. These operations only by professional personnel responsible for the operation of dialysis. This Standard does not apply to the dialysate regeneration system. | YY 0572-2015: Water for haemodialysis and related therapies---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Water for haemodialysis and related therapies
ICS 11.040.40
C45
People's Republic of China pharmaceutical industry standards
Replacing YY 0572-2005
Hemodialysis and related water treatment
(ISO 13959.2009, MOD)
Issued on. 2015-03-02
2017-01-01 implementation
China Food and Drug Administration released
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.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard was proposed by the China Food and Drug Administration.
The standard equipment by the National Technical Committee of Standardization for medical cardiopulmonary bypass (SAC/TC158) centralized.
This standard was drafted. State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. standard Wu Jing, Wu Weirong.
This standard was first published in 2005 and 2015, the first revision.
Hemodialysis and related water treatment
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 chlorinetotal
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 dialysiswater
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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