YY/T 0793.1-2022 English PDFUS$559.00 ยท In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0793.1-2022: (Preparation and quality management of fluids for hemodialysis and related treatments - Part 1: Water treatment equipment for hemodialysis and related treatments) Status: Valid YY/T 0793.1: Historical versions
Basic dataStandard ID: YY/T 0793.1-2022 (YY/T0793.1-2022)Description (Translated English): (Preparation and quality management of fluids for hemodialysis and related treatments - Part 1: Water treatment equipment for hemodialysis and related treatments) Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C45 Word Count Estimation: 30,381 Issuing agency(ies): State Drug Administration YY 0793.1-2010: Technical requirements of water treatment equipments for haemodialysis applications and related therapies. Part 1: For multi-beds haemodialysis---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. Technical requirements of water treatment equipments for haemodialysis applications and related therapies.Part 1. For multi-beds haemodialysis ICS 11.040.40 C45 People's Republic of China pharmaceutical industry standards Hemodialysis water treatment equipment and related treatment technology Part 1. For multi-bed dialysis Part 1. Formulti-bedshaemodialysis (ISO 26722.2009watertreatmentequipmentsforhaemodialysis applicationsandrelatedtherapies, NEQ) Issued on. 2010-12-27 2012-06-01 implementation State Food and Drug Administration issued ForewordAll the technical contents of this standard is mandatory. Hemodialysis treatment and related water treatment equipment technical standards required standard for the series, the series standard consists of two parts. --- Part 1. multi-bed for dialysis; --- Part 2. Single bed for dialysis. This standard is Part 1 YY 0793 of. This standard is not equivalent to international standards ISO 26722.2009 hemodialysis treatment and related water treatment equipment (in English). The different standards with international standards in that. --- With different names; --- To limit the scope of the standard to provide a multi-bed hospital hemodialysis water treatment equipment used; --- Increased "after the temperature compensation device actually treated water is not less than the nominal volume of treated water" requirements and test methods; --- Added "Electrical Requirements" clause, opt GB 9706.1 according to the electrical system and the degree of isolation of patients' medical electrical equipment Preparation Part 1. General requirements for safety "or GB 4793.1" measurement, control and laboratory safety of electrical equipment with the requirements of Part 1. General requirements "; --- Added "Categories", "working conditions", "inspection rules," "packaging, transport and storage" and other similar terms; --- Remove the International Standard for Portable water treatment equipment (single bed hemodialysis treatment and related water treatment equipment) correspond Terms; --- The treated water in line with the requirements and test methods "ISO 13959" is adjusted to meet the "YY 0572" hemodialysis and related therapies Water ""; --- The "Material compatibility" has been adjusted to form a "material requirements" clause, the main implementation of GB/T 17219 "in drinking Security Evaluation Criteria "water equipment and protective materials. This standard by the National Standardization Technical Committee extracorporeal medical device and focal point responsible for the interpretation. This standard was drafted. Medical Devices, Institute of Zhejiang Province, the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection center. The main drafters of this standard. Lv Weimin, Chen Jia Ye, Huang new Zengfan Feng, Chen Xianming, Liu Yi Qing, Yang Xiaohe, Fan Li Hang. Hemodialysis water treatment equipment and related treatment technology Part 1. For multi-bed dialysis1 ScopeThis standard specifies the multi-bed hemodialysis treatment and related water treatment equipment (hereinafter referred to as water treatment equipment) terms and definitions, product Classification, requirements, test methods, inspection rules, signs, instructions, packaging, transport and storage. This standard applies to the preparation of multi-bed dialysis treatment and related water treatment equipment, does not apply to preparation phase and single bed hemodialysis Off water treatment water treatment equipment. Water covered include. preparing a powder concentrate with water and dialysate preparation water, dialyzer reuse water. The standards required range from municipal water treatment equipment (including self-created) drinking water source into the device connection point to the point of use water production equipment Between all devices, piping and accessories, including. electrical systems, water purification systems, storage and delivery systems and disinfection systems. Not included. concentrate Liquid supply system, the dialysate regeneration system, dialysis concentrates, hemodiafiltration system, blood filtration system, dialyzer reuse system and peritoneum Dialysis system.2 Normative referencesThe following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB/T 191 Packaging - Pictorial signs (GB/T 191-2008, ISO 780.1997, MOD) GB 4793.1 measurement, control and laboratory safety requirements for electrical equipment Part 1. General requirements (GB 4793.1- 2007, IEC 61010-1.2001, IDT) GB 5749 drinking water health standards GB/T 5750.2 drinking water standard test method for water samples collection and preservation GB/T 5750.10 Standard examination methods for drinking water disinfection by-products index GB/T 5750.11 Standard examination methods for drinking water disinfectants Index GB 9706.1 Medical Electrical Equipment Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1. 1988, IDT) GB/T 9969 General Instructions industrial products GB/T 13074 Terms of blood purification GB/T 14710 medical electrical environmental requirements and test methods GB/T 17219 in drinking water safety equipment and protective materials evaluation criteria GB/T 18204.27 public places Determination of ozone in air Determination of GB/T 19108 peracetic acid YY/T 0466.1 medical equipment used with medical device labels and tags provide information symbols - Part 1. General requirements (YY 0466.1-2009, ISO 15223-1.2007, IDT) YY 0572 hemodialysis and related water treatment (YY 0572-2005, ISO 13959.2002, MOD)3 Terms and DefinitionsGB/T 13074 and established the following terms and definitions apply to this standard. 3.1 Chlorine, total chlorine chlorine, total Total residual chlorine or chlorine Chemical form chlorine and total chlorine free state. ...... |
