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Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 0603-2024: Cardiopulmonary bypass systems - Hard-shell cardiotomy/venous reservoir systems(with/without filter) and soft venous reservoir bags Status: Valid YY 0603: Historical versions
Basic dataStandard ID: YY 0603-2024 (YY0603-2024)Description (Translated English): Cardiopulmonary bypass systems - Hard-shell cardiotomy/venous reservoir systems(with/without filter) and soft venous reservoir bags Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: C45 Classification of International Standard: 11.040.40 Word Count Estimation: 18,141 Date of Issue: 2024-07-08 Date of Implementation: 2027-07-20 Older Standard (superseded by this standard): YY 0603-2015 Issuing agency(ies): State Drug Administration YY 0603-2024: Cardiopulmonary bypass systems - Hard-shell cardiotomy/venous reservoir systems(with/without filter) and soft venous reservoir bags---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. ICS 11.040.40 CCSC45 Pharmaceutical Industry Standards of the People's Republic of China Replaces YY 0603-2015 Cardiopulmonary bypass system, heart surgery, hard shell blood reservoir, Venous reservoir systems (with or without filter) and Venous blood storage bag (ISO 15674.2016,AMD1.2020,MOD) Released on 2024-07-08 2027-07-20 Implementation The State Drug Administration issued Table of ContentsPreface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirement 3 5 Test methods 5 Appendix A (Informative) Factors to be considered in evaluating performance characteristics 10 Appendix B (Informative) Reference Test Method 11 Reference 12ForewordThis document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document replaces YY 0603-2015 "Cardiovascular Implants and Artificial Organs Heart Surgery Hard Shell Blood Reservoir/Venous Blood Reservoir System Compared with YY 0603-2015, in addition to structural adjustments and editorial revisions, the main technical The changes are as follows. --- Deleted the static pre-charge of.2015 version 3.8; --- Changed the term and definition "dynamic pre-charge" (see 3.11); --- Added terms and definitions "thrombocytopenia", "free hemoglobin level in plasma", "leukopenia", "control blood reservoir", "filter (Removal rate) (see 3.12~3.16); --- Added bacterial endotoxins and corresponding test methods (see 4.1.2, 5.2.2); --- Deleted Note 2 in 4.2.3 of the.2015 edition; --- Added requirements for dynamic pre-charge volume, minimum and maximum capacity and corresponding test methods (see 4.3.9, 4.3.10, 5.4.9, 5.4.10); --- Modified the test methods for gas handling capacity, defoaming characteristics, filtration rate, and ethylene oxide residual (see 5.4.2, 5.4.4, 5.4.6, 5.6); --- Deleted Chapter 6 and Chapter 7 of the.2015 edition. This document is modified to adopt ISO 15674.2016 Cardiovascular implants and artificial organs - Hard shell blood reservoirs/venous blood reservoirs for cardiac surgery Systems (with or without filters) and venous blood storage bags" and Amendment No. 1 of 2020.This document is consistent with ISO 15674.2016 and 2020 The main technical differences and reasons of the amendment No. 1 of.2017 are as follows. --- The normative reference documents adopt the Chinese standards, and delete the ISO 80369-7.2016 cited in the 2020 amendment No. 1 to suit In our national conditions; --- Deleted 3.8 Static precharge. This term and definition are not referenced in the text; --- Move all the contents of 3.14.1 to 4.3.1.1.The relevant contents do not belong to terms and definitions; --- Added bacterial endotoxins and corresponding test methods (see 4.1.2, 5.2.2). According to my country's national standards, adding bacterial endotoxins is more suitable. In line with my country's national conditions; --- Deleted the second paragraph and Note 2 in 4.2.3 of Amendment No. 1 of 2020.my country has relevant standards for Luer connectors; --- Added chemical properties and test methods (see 4.4, 5.5). According to Chinese standards, adding chemical properties is more suitable for my country's national conditions; --- Added ethylene oxide residual content and test method (see 4.5, 5.6). According to Chinese standards, adding ethylene oxide residual content is more suitable my country's national conditions; --- The sterility and pyrogen-free test methods have been changed to adopt the common methods in my country to suit my country's national conditions; --- Adjusted the structure of Chapter 5, added performance characteristic test (5.4), corresponding to the requirements of Chapter 4; added test method gas Processing capacity, pre-fill volume, defoaming characteristics, capacity calibration, permeability, dynamic pre-fill volume, minimum capacity and maximum capacity (see 5.4.2, 5.4.3, 5.4.4, 5.4.5, 5.4.7, 5.4.8, 5.4.9) to enhance the operability of this document; --- The validity period test method has been changed to adopt the common method in my country to suit my country's national conditions; --- Deleted Chapter 6.my country already has relevant regulations on labeling; ---Chapter 7 has been deleted. my country already has relevant regulations on transportation. The following editorial changes were made to this document. --- Added references; --- Deleted the reference to ISO 15674.2016. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Extracorporeal Circulation Equipment (SAC/TC158). The previous versions of this document and the documents it replaces are as follows. ---First issued in.2007 as YY 0603-2007, first revised in.2015; ---This is the second revision. Cardiopulmonary bypass system, heart surgery, hard shell blood reservoir, Venous reservoir systems (with or without filter) and Venous blood storage bag1 ScopeThis document specifies sterile, single-use, extracorporeal circulation cardiac surgery hard-shell blood reservoirs and hard-shell venous blood reservoir systems (with or without The requirements for filters) and venous blood storage bags (referred to as blood reservoirs) describe the corresponding test methods. Blood reservoirs are intended for cardiopulmonary bypass surgery. Used for blood storage during CPB. This document applies only to blood reservoirs in multifunctional systems which may have integrated components such as blood gas exchangers (oxygenators), blood Filters, defoamers, blood pumps, etc.2 Normative referencesThe contents of the following documents constitute essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB/T 14233.1-2022 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods GB/T 14233.2-2005 Test methods for medical infusion, blood transfusion and injection equipment Part 2.Biological test methods GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process (GB/T 16886.1- 2022,ISO 10993-1.2018,IDT) GB/T 16886.11 Biological evaluation of medical devices Part 11.Systemic toxicity tests (GB/T 16886.11-2021, ISO 10993-11.2017, IDT) GB/T 16886.12 Biological evaluation of medical devices Part 12.Sample preparation and reference materials (GB/T 16886.12- 2017,ISO 10993-12.2012,IDT) GB 18279.1 Sterilization of healthcare products with ethylene oxide Part 1.Development, validation and routine control of sterilization processes for medical devices System requirements (GB 18279.1-2015, ISO 11135-1.2007, IDT) GB 18280.1 Radiation sterilization of health care products Part 1.Development, validation and routine control of sterilization processes for medical devices Request (GB 18280.1-2015, ISO 11137-1.2006, IDT) GB/T.19974 Characteristics of sterilization factors for medical health products and general requirements for the setting and confirmation of sterilization processes for medical devices Requirements (GB/T.19974-2018, ISO 14937.2009, IDT) YY 0580-2024 Cardiovascular implants and artificial organs Cardiopulmonary bypass system arterial line blood filter YY/T 0681.1-2018 Test methods for sterile medical device packaging Part 1.Guide to accelerated aging tests Pharmacopoeia of the People's Republic of China 2020 Edition Volume 43 Terms and definitionsThe following terms and definitions apply to this document. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 0603-2024_English be delivered?Answer: Upon your order, we will start to translate YY 0603-2024_English as soon as possible, and keep you informed of the progress. 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