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YY 0948-2025 English PDF

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Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0948-2025 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.

US$519.00 · In stock
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YY 0948-2025: Cardiopulmonary bypass systems - Arteriovenous cannula for single use
Status: Valid

YY 0948: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0948-2025	519	Add to Cart	5 days	Cardiopulmonary bypass systems - Arteriovenous cannula for single use	Valid
YY 0948-2015	150	Add to Cart	Auto, < 3 mins	Cardiopulmonary bypass systems. Arteriovenous cannula for single use	Valid

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Older Standard (superseded by this standard): YY 0948-2015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

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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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY 0948-2025_English be delivered?

Answer: Upon your order, we will start to translate YY 0948-2025_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY 0948-2025_English with my colleagues?

Answer: Yes. The purchased PDF of YY 0948-2025_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. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version YY 0948-2025?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0948-2025 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.