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YY 0948-2025: Cardiopulmonary bypass systems - Arteriovenous cannula for single use
Status: Valid YY 0948: Evolution and historical versions
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Cardiopulmonary bypass systems - Arteriovenous cannula for single use
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YY 0948-2025
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| YY 0948-2015 | English | 150 |
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Cardiopulmonary bypass systems. Arteriovenous cannula for single use
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YY 0948-2015
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Basic data | Standard ID | YY 0948-2025 (YY0948-2025) | | Description (Translated English) | Cardiopulmonary bypass systems - Arteriovenous cannula for single use | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 26,211 | | Date of Issue | 2025-06-18 | | Date of Implementation | 2028-07-01 | | Older Standard (superseded by this standard) | YY 0948-2015 | | Issuing agency(ies) | National Medical Products Administration | YY 0948-2025: Cardiopulmonary bypass systems - Arteriovenous cannula for single use---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0948-2025
ICS 11.040.40
CCSC45
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0948-2015
Disposable arteriovenous cannula for cardiopulmonary bypass system
Released on June 18, 2025
Implementation on July 1, 2028
The State Food and Drug Administration issued
Table of Contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirement 3
4.1 Biological properties 3
4.2 Physical properties 4
4.3 Performance Characteristics 5
4.4 Chemical properties 5
4.5 Ethylene oxide residue 6
4.6 Corrosion resistance 6
4.7 Pollution Index 6
5 Test methods 6
5.1 General requirements 6
5.2 Biological performance test 6
5.3 Physical properties test 6
5.4 Performance characteristics test 8
5.5 Chemical performance test 10
5.6 Ethylene oxide residue 10
5.7 Corrosion resistance test 11
5.8 Pollution Index Test 11
Appendix A (informative) Recirculation test setup 12
Appendix B (informative) Test setup for kink resistance 15
Appendix C (Informative) Experimental setup for blood cell disruption 17
Reference 21
Preface
This 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 0948-2015 "Disposable Arteriovenous Cannula for Cardiopulmonary Bypass System" and is
In addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- Deleted the classification and structure of the original standard (see Chapter 3 of the.2015 edition), and added terms and definitions (see Chapter 3);
--- Deleted pyrogen-free and corresponding test methods (see.2015 version 4.3.3, 5.3.3), added bacterial endotoxins and corresponding test methods
(See 4.1.2, 5.2.2);
--- Changed the biocompatibility and corresponding test methods (see 4.1.3, 5.2.3, 4.1.3, 5.2.3 of the.2015 edition);
--- Added joints and corresponding test methods (see 4.2.2, 5.3.2);
--- Added kink resistance and corresponding test methods (see 4.2.3, 5.3.3), deleted the original standard bending resistance and corresponding test methods (see
2015 editions 4.2.4 and 5.2.4);
--- Added tensile strength and corresponding test methods (see 4.2.4, 5.3.4);
--- Changed the appearance (see 4.2.5, 4.1 of the.2015 edition);
--- Added integrity and corresponding test methods (see 4.2.6, 5.3.6);
--- Added radiographic detectability and corresponding test methods (see 4.2.7, 5.3.7);
--- Added distance marking and corresponding test methods (see 4.2.8, 5.3.8);
--- Added lumen marking and corresponding test methods (see 4.2.9, 5.3.9);
--- Added pressure drop and corresponding test methods (see 4.3.1, 5.4.1);
--- Added anti-collapse and corresponding test methods (see 4.3.2, 5.4.2);
--- Added recycling and corresponding test methods (see 4.3.3, 5.4.3);
--- Added blood cell destruction and corresponding test methods (see 4.3.4, 5.4.4);
---Corrosion resistance has been changed (see 4.6, 4.5 of the.2015 edition);
--- Changed the pollution index and corresponding test method (see 4.7, 5.8, 4.6, 5.6 of the.2015 edition);
--- Added general requirements (see 5.1);
--- Changed the preparation of test solution (see 5.5.1, 5.4.1 of the.2015 edition);
--- Changed the ethylene oxide residual content (see 5.6, 5.4.8 of the.2015 edition).
This document is modified to adopt the international standard ISO 18193.2021 (3rd edition) “Cardiovascular implants and artificial organs for extracorporeal circulation”
Intubation.
The technical differences between this document and ISO 18193.2021 and their reasons are as follows.
--- Deleted the abbreviations in the scope to suit my country's national conditions;
--- The scope has been increased to include "This document applies to disposable sterile arteriovenous cannulas used for drainage or perfusion of blood".
my country's national conditions;
---Replaced ISO 11607-1, GB/T 14233.2-2005 and Pharmacopoeia of the People's Republic of China (2020 edition) with normative references
ISO 11607-2, ISO 80369-7, ISO 17665-1, ISO 11135, ISO 11137-1, ISO 14937 and ISO 10993-11 (see
5.2.1, 5.2.2) to adapt to my country's technical conditions and increase operability;
--- Replaced ISO 10993-1, ISO 10993-4 and ISO 10993-7 (see 5.2.3) with the normative reference GB/T 16886.1 to apply
Adapt to my country's technical conditions and increase operability;
---Replaced ASTMF640-12 and DIN13273-7 (see 5.3.7) with the normative reference YY/T 0586-2016 to adapt
my country's technical conditions and increased operability;
--- Added references to GB/T 1962.1-2015, GB/T 1962.2-2001, GB/T 14233.1-2022, YY/T 0149-
2006, YY/T 0681.1-2018, and YY/T 1556-2017, to suit my country's national conditions and increase operability;
--- Deleted the original standard terms and definitions of integrated components, legal dimensions, and primary packaging (see 3.6, 3.18, and 3.19).
There are no citations in the text;
--- The original standard pyrogens and corresponding test methods (see 4.1.1 and 5.2.1 of ISO 18193.2021) have been deleted to suit my country's national conditions;
--- Added bacterial endotoxins and corresponding test methods (see 4.1.2, 5.2.2) to suit my country's national conditions;
--- Changed the appearance (see 4.2.5) to suit my country's national conditions;
--- Changed the validity period and corresponding test methods (see 4.3.5, 5.4.5) to suit my country's national conditions;
--- Changed the blood cell destruction and corresponding test methods (see 4.3.4, 5.4.4) to suit my country's national conditions;
--- Added chemical properties, ethylene oxide residue, corrosion resistance, pollution index and test methods (see 4.4~4.7, 5.5~5.8),
Suitable for my country's national conditions;
--- The sterility test method (see 5.2.1) has been changed to adopt the common method in my country to suit my country's national conditions;
--- The biocompatibility test method (see 5.2.3) has been changed to adopt the general method in my country to suit my country's national conditions;
--- Changed the joint test method (see 5.3.2) to suit my country's national conditions;
--- Changed the kink resistance test method (see 5.3.3) to increase the operability of the standard;
--- Added appearance test method (see 5.3.5) to increase the operability of the standard;
--- Changed the integrity test method (see 5.3.6) to increase the operability of the standard;
--- Added distance marking test method (see 5.3.8) to increase the operability of the standard;
--- Added the lumen marking test method (see 5.3.9) to increase the operability of the standard;
--- Added blood cell destruction test method (see 5.4.4) to increase the operability of the standard;
--- Changed the pressure drop test method (see 5.4.1) to increase the operability of the standard;
--- Changed the recycling test method (see 5.4.3) to increase the operability of the standard;
--- Deleted Chapter 6, Chapter 7 and Appendix A of the original standard. my country already has relevant regulations.
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.2015 as YY 0948-2015;
---This is the first revision.
Disposable arteriovenous cannula for cardiopulmonary bypass system
1 Scope
This document specifies the procedures for cardiopulmonary bypass, extracorporeal lung assistance, left or right heart bypass, cardiopulmonary support, extracorporeal life support, extracorporeal oxygenation,
Requirements for disposable sterile arteriovenous cannulas used for drainage or perfusion of blood during carbon dioxide removal and other extracorporeal circulation techniques
The corresponding test methods are described.
This document applies to disposable sterile arteriovenous cannulas for use in drainage or perfusion of blood.
This document does not apply to.
---Guiding devices (e.g., guide wires) described in YY 0450.1-2020;
---Isolated organ perfusion cannula;
---Intravascular catheters described in YY 0285.3-2017.
2 Normative references
The contents of the following documents constitute the 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 ∕T1962.1-2015 Syringes, needles and other medical devices 6% (Luer) cone connector Part 1.General requirements
(ISO 594-1.1986, IDT)
GB/T 1962.2-2001 6% (Luer) cone connectors for syringes, needles and other medical devices Part 2.Locking connectors
(ISO 594-2.1998, IDT)
GB/T 14233.1-2022 Test 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)
YY/T 0149-2006 Test method for corrosion resistance of stainless steel medical devices (ISO 13402.1995, MOD)
YY/T 0586-2016 Test method for X-ray opacity of medical polymer products
YY/T 0681.1-2018 Test methods for sterile medical device packaging Part 1.Guide to accelerated aging tests
YY/T 1556-2017 Test method for particulate contamination of medical infusion, blood transfusion and injection equipment
Pharmacopoeia of the People's Republic of China 2020 Edition
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Blood is circulated through an extracorporeal circuit for use when the heart and/or lungs are temporarily unable to function properly (e.g. due to
disease) to support or replace the patient's circulatory and/or gas exchange requirements, including arteriovenous cannulae, oxygenators, circuits, and/or other devices (e.g.
For example, blood pumps, arterial filters, blood reservoirs, etc.).
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