YY/T 1545-2017 English PDFUS$139.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1545-2017: Evaluation of connection between haemodialysis concentrate and haemodialysis equipment Status: Valid
Basic dataStandard 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: 7,739 Date of Issue: 2017-05-02 Date of Implementation: 2018-04-01 Regulation (derived from): China Food & Drug Administration Announcement 2017 No. 49 Issuing agency(ies): State Food and Drug Administration YY/T 1545-2017: Evaluation of connection between haemodialysis concentrate and haemodialysis equipment---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. 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 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 General 1 Reference 4 ForewordThis 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 connection1 ScopeThis 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 referencesThe 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 definitionsGB/T 13074 defined terms and definitions apply to this document.4 General rules4.1 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 ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1545-2017_English be delivered?Answer: Upon your order, we will start to translate YY/T 1545-2017_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 1545-2017_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1545-2017_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. 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