YY/T 1545-2017 (YY/T1545-2017, YYT 1545-2017, YYT1545-2017) & related versions
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Evaluation of connection between haemodialysis concentrate and haemodialysis equipment
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YY/T 1545-2017
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YYT 1545-2017
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YY/T 1545-2017: PDF in English (YYT 1545-2017)
YY/T 1545-2017
Evaluation of connection between hamodialysis concentrate and haemodialysis equipment
ICS 11.040.40
C45
People's Republic of China pharmaceutical industry standards
Hemodialysis concentrates and hemodialysis equipment
Evaluation of the connection
Evaluation of connection between hamodialysis
2017-05-02 released
2018-04-01 implementation
State Food and Drug Administration released
Directory
Foreword Ⅲ
1 range 1
2 Normative references 1
3 Terms and definitions 1
4 General 1
Reference 4
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents.
This standard proposed by the State Food and Drug Administration.
This standard by the National Medical Equipment Corps Standardization Technical Committee (SAC/TC158) centralized.
This standard was drafted by the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Guangzhou Kang Sheng biotechnology
Limited company.
The main drafters of this standard. Blue Jianhua, Wu Jingbiao, Chen campus, He Xiaofan.
Hemodialysis concentrates and hemodialysis equipment
Evaluation of the connection
1 Scope
This standard specifies the dialysis concentrate, dialysis powder and other hemodialysis concentrates containers and hemodialysis equipment connected to the evaluation requirements.
NOTE The means of connection provided by the manufacturer, seller or user of hemodialysis concentrates and hemodialysis equipment shall meet the requirements of this standard.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 13074 blood purification terms
Pharmacopoeia of the People's Republic of China (2010 edition 2)
3 Terms and definitions
GB/T 13074 defined terms and definitions apply to this document.
4 General rules
4.1 Purpose
This standard was developed to reduce the risk of hemodialysis concentrates being contaminated during hemodialysis and slowing the dialysis concentrate's
Volatile.
4.2 principles
At this stage, hemodialysis concentrate and hemodialysis equipment there are a variety of connections, the standard hemodialysis concentrate in the course of treatment
In the changes and possible secondary pollution evaluation.
4.3 Evaluation Indicators
4.3.1 visible foreign body
Hemodialysis equipment and dialysis concentrate connected, placed 12h, concentrate should be no visible foreign body.
4.3.2 Particles
Hemodialysis equipment and dialysate concentrate connected, placed 12h, dialysate concentrate diluted into dialysate after the insoluble particulate condition.
Microparticles ≥10 μm should not be larger than 25/mL, and particles ≥ 25 μm should not be larger than 3/mL.
4.3.3 Conductivity
Hemodialysis equipment and dialysis concentrate connected, placed 12h, dialysis concentrate diluted to dialysis fluid conductivity should be at
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| Standard ID | YY/T 1545-2017 (YY/T1545-2017) | | Description (Translated English) | Evaluation of connection between haemodialysis concentrate and haemodialysis equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 7,716 | | Date of Issue | 2017-05-02 | | Date of Implementation | 2018-04-01 | | Drafting Organization | State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Guangzhou Kang Sheng Biological Technology Co., Ltd. | | Administrative Organization | National Medical Equipment for Standardization Technical Committee (SAC/TC 158) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 49 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration |
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