YY/T 1269-2015Routine control requirements for water treatment equipments for haemodialysis applications and related therapies (English PDF)
血液透析和相关治疗用水处理设备常规控制要求
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 2, 2015
Implementation date
January 1, 2016
Scope
YY/T 1269-2015 is the English-translated version of 血液透析和相关治疗用水处理设备常规控制要求.
YY/T 1269-2015 is the Chinese pharmaceutical industry standard that sets the routine control requirements for the water treatment equipment used in haemodialysis, the plant that prepares the water from which dialysis fluid is made.
It gives the terms and definitions, the requirements and the test methods: the quality required of the treated water, the requirements on the treatment equipment itself, the environment in which it stands and the personnel who run it, so that the water is still within limits at the point of use.
It is written for the people who design, make and operate such plant, and it does not apply to the equipment, maintenance and monitoring of single-bed routine haemodialysis. Issued on 2 March 2015, it has applied since 1 January 2016.
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Document preview — YY/T 1269-2015
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C 45
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Requirements
- 4.1 Overview
- 4.2 3 treated water quality requirements
- 4.3 Water Treatment Equipment Requirements
- 4.4 Environmental Requirements
- 4.5 personnel requirements
- 5 Test methods
- 5.1 Test Overview
- 5.2 treated water quality requirements, test
- 5.3 Water treatment equipment requirements Test
- 5.4 Environmental Requirements
- 5.5 personnel requirements
- Appendix A (normative) treated water sampling and detection of microbial indicators preparation requirements
- A.1 General
- A.2 sample collection
- A.3 Sample preparation
- Methods Appendix B (informative) to control bacterial
- B.1 Overview
- Hazard and Control B.2 biofilm
- B.3 Other Considerations
- Annex C (informative) chemical injection device
- C.1 Overview
- C.2 chemical characteristics of the injection device
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
1 Scope
This standard specifies the hemodialysis treatment and related water treatment equipment (hereinafter referred to as water treatment equipment) general control requirements, including standard Quasi applicable terms and definitions, requirements and test methods. The purpose is to prepare specifications hemodialysis and related water treatment, and water treatment equipment Use, maintenance and monitoring procedures to ensure the quality of treated water at the time of use are in line with the relevant provisions.
The standard water treatment equipment and technology researchers, manufacturers, use the unit responsible for the preparation and organization of treated water use.
This standard does not apply to single-bed routine hemodialysis treatment and related water treatment equipment, maintenance and monitoring.
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 Terms of blood purification
YY 0572 hemodialysis and related water treatment
YY 0793.1 hemodialysis treatment water treatment equipment and related technology - Part 1. For multi-bed dialysis
3 Terms and Definitions
GB/T 13074, YY 0572 and YY 0793.1 given as well as the following terms and definitions apply to this document.
3.1 Apparatus device
Included in the device individual functions water treatment unit. Such as. softeners, carbon adsorption tanks, reverse osmosis, deionization devices.
3.2 Manufacturer
Engaged in the design, manufacture, assembly, device assembly and processing organization or unit.
NOTE. Manufacturers include, but are not limited to, those in sub-sterilization, installation, OEM, reprocessing, repackaging or person or body preparing specifications, as well as abroad Companies perform the above functions of a distributor.
4 Requirements
4.1 Overview
In order to ensure hemodialysis and related water treatment has been effectively controlled, the requirements formulated in the manufacturing process to meet the daily monitoring and Quality control needs. The use of units monitoring frequency generally by the manufacturer of the device to provide for, or Table 1 specification requirements of the system Supplement manufacturer recommendations.
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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
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Related Standards
GB/T 13074-2024 — Blood purification terminology
YY 0572-2005 — Water for haemodialysis and related therapies
YY 0572-2015 — Water for haemodialysis and related therapies
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