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YY 0598-2015: Concentrates for haemodialysis and related therapies
Status: Valid YY 0598: Evolution and historical versions
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Concentrates for haemodialysis and related therapies
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YY 0598-2015
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| YY 0598-2006 | English | 519 |
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Concentrates for haemodialysis and related therapies
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YY 0598-2006
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Basic data | Standard ID | YY 0598-2015 (YY0598-2015) | | Description (Translated English) | Concentrates 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Count Estimation | 20,258 | | Date of Issue | 2015-03-02 | | Date of Implementation | 2017-01-01 | | Older Standard (superseded by this standard) | YY 0598-2006 | | Quoted Standard | GB/T 13074-2009; YY 0572; USO 11663-2009; WS-10001-(HD-0476)-2002 | | Adopted Standard | ISO 13958-2009, 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 process purity, microbiological contamination, concentrate, concentrate composition of its chemical composition, measurement requirements and labeling containers and concentration of the test material A test was needed. This Standard applies to hemodialysis and related therapeutic concentrates. This Standard does not apply to the treatment of concentrates and dialysis water formulated into a final concentration of the mixing process. This Standard does not apply dialysate regeneration system. | YY 0598-2015: Concentrates 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.
Concentrates for haemodialysis and related therapies
ICS 11.040.40
C45
People's Republic of China pharmaceutical industry standards
Replacing YY 0598-2006
Hemodialysis and related therapeutic concentrates
(ISO 13958.2009, MOD)
Issued on. 2015-03-02
2017-01-01 implementation
China Food and Drug Administration released
Table of Contents
Introduction Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions
Feed 3 4
5 Requirements 4
Test Method 5 6
7 Logo 7
Appendix A (informative) The main technical differences between this standard and its Causes 9 YY 0598-2006
Annex B (informative) This standard and ISO 13958.2009 and its main technical difference 10 reasons
Annex C (informative) equipment and other related requirements 11
References 16
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard replaces YY 0598-2006 "hemodialysis and related therapeutic concentrates", compared with YY 0598-2006, in addition to editorial repair
External change, the main technical difference in Appendix A.
This revised standard adopts ISO 13958.2009 "hemodialysis and related therapeutic concentrates." This standard and ISO 13958.2009 Main
To technical differences in Appendix B.
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. Huangmin Ju, Heyan Ying, Wang Pei even.
This standard was first published in 2006 and 2015, the first revision.
Hemodialysis and related therapeutic concentrates
1 Scope
This standard specifies the need to concentrate the chemical composition and purity, microbiological contamination, concentrate processing, measurement and identification, container
Sum concentrate quality inspection of the test was required.
This standard applies to hemodialysis and related therapeutic concentrates.
This standard does not apply to the treatment of concentrates and dialysis water formulated into a final concentration of the mixing process.
This standard does not apply 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
YY 0572 hemodialysis and related water treatment (YY 0572-2015, ISO 13959.2009, MOD)
ISO 11663.2009 hemodialysis and related therapeutic dialysate (Qualityofdialysisfluidforhaemodialysisand
relatedtherapies, MOD)
WS-10001- (HD-0476) -2002 chloride
People's Republic of China Pharmacopoeia (two) (2010 Edition)
3 Terms and Definitions
GB/T 13074-2009 and define the following terms and definitions apply to this document.
3.1
Acetate concentrate acetateconcentrate
Mixture containing acetic acid salts is used when diluted to the ratio specified without bicarbonate dialysate after the dialysis water, through clinical
Analysis of treatment.
Note 1. acetate concentrate may contain glucose.
Note 2. sodium acetate, sodium bicarbonate as a buffer replacement.
Note 3. The acetate concentrates usually as a single concentrate.
3.2
Acid concentrate acidconcentrate
A-concentrate A concentrate
Acidic mixture containing salts, when used according to the specified ratio with water and bicarbonate dialysis concentrate formulated as dialysate, the clinical
Dialysis.
Note 1. The acid refers to the small amount of acid, usually it refers to has been present in the concentrate of acetic acid.
Note 2. acidic concentrate may contain glucose.
Note 3. acidic concentrate may be a liquid, powder or the mixed state of the previous two.
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