YY 1048-2016 English PDFUS$199.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 1048-2016: Cardiopulmonary bypass systems. Extracorporeal blood circuit Status: Valid YY 1048: Historical versions
Basic dataStandard ID: YY 1048-2016 (YY1048-2016)Description (Translated English): Cardiopulmonary bypass systems. Extracorporeal blood circuit Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: C45 Classification of International Standard: 11.040.40 Word Count Estimation: 10,188 Date of Issue: 2016-03-23 Date of Implementation: 2018-01-01 Older Standard (superseded by this standard): YY 1048-2007 Quoted Standard: GB/T 191; GB/T 1962.1; GB/T 1962.2; GB/T 5750.6-2006; GB/T 9969; GB/T 14233.1-2008; GB/T 14233.2-2005; GB/T 16886.1; GB 18279; GB 18280; GB 19335-2003; YY/T 0313-1998; YY/T 0466.1-2009; YY/T 0681.1-2009 Regulation (derived from): Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies the classification and naming, requirements, test methods, marking, packaging, transportation and storage of cardiopulmonary bypass systems for extracorporeal circulation pipelines (hereinafter referred to as tubes). This standard applies to cardiopulmonary bypass system used in cardiopulmonary bypass piping and its associated as a whole pipeline, the product in cardiovascular surgery for extracorporeal circulation as a blood channel and channel connection, for a one-time use. YY 1048-2016: Cardiopulmonary bypass systems. Extracorporeal blood circuit---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.Cardiopulmonary bypass systems .Extracorporeal blood circuit ICS 11.040.40 C45 People's Republic of China Pharmaceutical Industry Standard Replacing YY 1048-2007 Cardiopulmonary bypass system for extracorporeal circulation 2016-03-23 release 2018-01-01 implementation State Food and Drug Administration issued Directory Preface I 1 Scope 1 2 normative reference document 1 Classification and composition 4 Requirements 1 4.1 Appearance 1 4.2 Physical properties 2 4.3 Biological properties 2 4.4 Chemical properties 2 4.5 valid period 3 5 Test methods 3 5.1 Appearance 3 5.2 Physical properties 3 5.3 Biological properties 3 5.4 Chemical performance test 3 5.5 Validity test 4 6 mark, packaging, transportation, storage 4 Reference 6 ForewordThis standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 1048-2007 "artificial heart and lung cardiopulmonary bypass pipeline", this standard and YY 1048-2007 main technology The differences are as follows. - increased requirements for validity (see 4.5) and corresponding test methods (see 5.5); - modified biological performance requirements (see 4.3.1,.2007 edition 4.3.1); - modified no leak test conditions (see 5.2.1,.2007 edition 5.2.1); - Modification of the test solution preparation method (see 5.4.1,.2007 edition 5.4.1); --- Delete size requirements (2007 edition 3.4); --- Remove inspection rules (2007 edition 6). Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Extracorporeal Circulation Equipment Standardization Technical Committee (SAC/TC158) centralized. The drafting of this standard. Ningbo Feilal Medical Supplies Co., Ltd., the State Food and Drug Administration Guangzhou Medical Equipment Quality Supervision Supervisory center. The main drafters of this standard. Hong Liang Tong, Xu Zhaosheng, Xiong Wei, He Xiaofan, Shen Junbo. This standard replaced the previous version of the standard release. --- WS2-301-1983; --- GB 12264-1990; --- YY 91048-1999; --- YY 1048-2007. Cardiopulmonary bypass system for extracorporeal circulation1 ScopeThis standard specifies the cardiopulmonary bypass system of extracorporeal circulation pipeline (hereinafter referred to as the pipeline) classification and naming, requirements, test methods, signs, packages Equipment, transportation, storage. This standard applies to cardiopulmonary bypass system used in the extracorporeal circulation of the pipeline and its associated with the auxiliary pipeline, the product in the cardiovascular Surgery for extracorporeal circulation as a blood channel and channel connection used for one-time use.2 normative reference documentsThe following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 191 packaging and storage icon GB/T 1962.1 Syringes, injection needles and other medical devices 6% (Ruhr) Conical joints Part 1. General requirements GB/T 1962.2 Syringes, injection needles and other medical devices 6% (Ruhr) Conical joints Part 2. Locking joints Standard Test Method for Drinking Water of Metals - Metals Indicators GB/T 5750.6-2006 General rules for the use of industrial products GB/T 9969 GB/T 14233.1-2008 Methods of test for medical infusion, transfusion, and injectable utensils - Part 1. Chemical analysis methods GB/T 14233.2-2005 Methods of examination for medical infusion, transfusion, and injectable utensils - Part 2. Biological test methods GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management GB 18279 Sterilization and routine control of ethylene oxide for medical devices GB 18280 Health care products Sterilization confirmation and routine control requirements Radiation sterilization General technical conditions for disposable blood use products GB 19335-2003 Packaging, marking, transportation and storage of medical polymer products YY/T 0313-1998 Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1. Generic Claim Test methods for packaging of sterile medical devices - Part 1. Guidelines for accelerated aging testing YY/T 0681.1-2009 Classification and composition 3.1 pipeline generally by the pipeline, joints, pump and other components. 3.2 Pipes are generally divided into 4.8mm (3/16 "), 6.3mm (1/4"), 9.5mm (3/8 "), 12.7mm (1/2") and other specifications Grid is specified by the manufacturer). 3.3 connector is generally divided into three links, through joints, side hole through joints and so on.4 requirements4.1 appearance 4.1.1 pipeline should be translucent or transparent, inside and outside the surface should be smooth, plastic uniform, no kink, the end should be neat no cracks. ...... |
