YY 0572-2015 in English

Water for haemodialysis and related therapies

1 Scope

This standard specifies minimum requirements for water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and on-line haemofiltration or on-line haemodiafiltration and for the reprocessing of haemodialysers.

This standard does not address the operation of water treatment equipment nor the final mixing of treated water with concentrates to produce the dialysis fluids used in such therapies. That operation is the sole responsibility of dialysis professionals.

This standard does not apply to dialysis fluid regenerating systems.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

GB/T 13074-2009 Terms of blood purification
Pharmacopoeia of the People’s Republic of China (Volume II) (2010 Edition)

3 Terms and definitions

For the purposes of this document, the terms and definitions given in GB/T 13074 and the following apply.

3.1
action level
concentration of a contaminant at which steps shall be taken to interrupt the trend toward higher, unacceptable levels

3.2
chlorine total
sum of free and combined chlorine

Note: chlorine can exist in water as dissolved molecular chlorine (free chlorine) or in chemically combined forms (combined chlorine). Where chloramine is used to disinfect water supplies, chloramine is usually the principal component of combined chlorine.

Foreword II
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
Annex A (Informative) Rationale for the development and provisions of ISO 13959:2009
Annex B (Informative) Analytical methods for chemical contaminants
Bibliography