Valid

YY 0598-2015Concentrates for haemodialysis and related therapies (English PDF)

血液透析及相关治疗用浓缩物

Preview PDF

This is a limited preview

Buy now to download the full PDF (23 pages)

Need quotation for your management?

Get a formal quotation for YY 0598-2015 in 30 minutes.

Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

March 2, 2015

Implementation date

January 1, 2017

Scope

YY 0598-2015 is the English-translated version of 血液透析及相关治疗用浓缩物.

YY 0598-2015 is the Chinese standard for the concentrates from which haemodialysis fluid is prepared.

It sets the chemical composition and the purity required of the concentrate, the limits on microbiological contamination, the way the concentrate is processed, measured and identified, the requirements on its containers, and the tests by which its quality is checked.

It applies to concentrates for haemodialysis and related therapies, and not to the mixing of concentrate with dialysis water to the final concentration at the point of treatment, nor to dialysate regeneration systems.

It replaces YY 0598-2006, was issued on 2 March 2015 and has applied since 1 January 2017.

Found what you need?

Document preview — YY 0598-2015

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C 45
Replacing: YY 0598-2006

Issued by: National Medical Products Administration of the People's Republic of China

Introduction
1 Scope
2 Normative references
3 Terms and definitions Feed
5 Requirements
Test Method 5
7 Logo
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
References

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.

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

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

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 11663:2009

Similar standards

YY 0793.3-2023|YY 0793.2-2023|YY/T 0793.1-2022|YY/T 0793.4-2022

Editions of YY 0598

Edition	Title	Revision	Status
YY 0598-2015	Concentrates for haemodialysis and related therapies	current edition	Current
YY 0598-2006	Concentrates for haemodialysis and related therapies	previous edition	Superseded

This page sells the current edition, YY 0598-2015. Earlier editions are listed for reference only.

How to Download YY 0598-2015

1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.