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YY 0598-2015 English PDF

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Q: Should I purchase the latest version YY 0598-2015?

Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0598-2015 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.

US$419.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 0598-2015: Concentrates for haemodialysis and related therapies
Status: Valid

YY 0598: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0598-2015	419	Add to Cart	4 days	Concentrates for haemodialysis and related therapies	Valid
YY 0598-2006	519	Add to Cart	4 days	Concentrates for haemodialysis and related therapies	Obsolete

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YY/T 0640 YY/T 0663.2 YY/T 0606.9 YY 0603 YY/T 0606.15

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Older Standard (superseded by this standard): YY 0598-2006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

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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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY 0598-2015_English be delivered?

Answer: Upon your order, we will start to translate YY 0598-2015_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY 0598-2015_English with my colleagues?

Answer: Yes. The purchased PDF of YY 0598-2015_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version YY 0598-2015?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0598-2015 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.