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YY/T 0730-2023 English PDF

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YY/T 0730-2023: (Cardiovascular surgical implants and artificial organs - Requirements for single-use tubing sets for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO))
Status: Valid

YY/T 0730: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0730-2023English279 Add to Cart 3 days [Need to translate] (Cardiovascular surgical implants and artificial organs - Requirements for single-use tubing sets for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)) Valid YY/T 0730-2023
YY/T 0730-2009English439 Add to Cart 3 days [Need to translate] Cardiovascular implants and artificial organs. Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation(ECMO) Obsolete YY/T 0730-2009

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Basic data

Standard ID YY/T 0730-2023 (YY/T0730-2023)
Description (Translated English) (Cardiovascular surgical implants and artificial organs - Requirements for single-use tubing sets for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO))
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C45
Classification of International Standard 11.040.40
Word Count Estimation 13,157
Date of Issue 2023-01-13
Date of Implementation 2024-01-15
Issuing agency(ies) State Drug Administration
Summary This standard specifies the requirements for single-use tubing sets used for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This standard applies to all medical pipelines expected to be used for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but during CPB surgery (short-term, i.e. less than 6h) or ECMO (long-term, i.e. more than 24h) Tubing intended for use with blood pumps has specific requirements and test methods. The provisions of this standard concerning sterility and pyrogen-free apply to tubing sets marked "sterile". This standard applies only to piping for multifunctional systems that may have complete components such as blood gas exchangers (oxygenators), blood reservoirs, blood microembolus filters, defoamers, blood pumps, etc.

YY/T 0730-2023: (Cardiovascular surgical implants and artificial organs - Requirements for single-use tubing sets for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO))



---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 Standard of the People's Republic of China Replacing YY/T 0730-2009 Cardiovascular Surgical Implants and Artificial Organs Cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) Requirements for single-use tubing kits oxygenation (ECMO) 2023-01-13 release 2024-01-15 implementation Released by the State Drug Administration

table of contents

Preface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 2 4 Requirements 3 4.1 Biological performance 3 4.2 Physical properties 3 4.3 Performance 3 4.4 Coating 4 5 Test method 4 5.1 General requirements 4 5.2 Biological properties 4 5.3 Physical properties 4 5.4 Performance 5 5.5 Coating 5 Appendix A (informative) Technical differences between this document and ISO 15676.2016 and their reasons 6 Appendix B (Informative) Particle Shedding Reference Test Method 8

foreword

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/T 0730-2009 "Cardiovascular Surgical Implants and Artificial Organs Cardiopulmonary Bypass and Extracorporeal Membrane Oxygenation (ECMO) Requirements for Single-Use Conduit Packages, compared with YY/T 0730-2009, except for structural adjustments and editorial changes In addition, the main technical changes are as follows. --- Deleted some normative references (GB/T 19633 and ASTM standards in Chapter 2 of the.2009 edition); --- Added some terms (see 3.9, 3.10, 3.11); --- Added the requirement of validity period and test method (see 4.3.4, 5.4.4); --- Added coating requirements and test methods (see 4.4, 5.5); --- Deleted the information and packaging provided by the producer (see Chapters 6 and 7 of the.2009 edition). This document is modified to adopt ISO 15676.2016 "Cardiopulmonary bypass and extracorporeal membrane oxygenation for implants and artificial organs in cardiovascular surgery Requirements for Single-Use Tubing Sets for Use by (ECMO)". A description of the technical differences between this document and ISO 15676.2016 and their reasons is given in Appendix A. The following editorial changes have been made to this document. --- Chapter 1 adds a note to explain the terms "membrane oxygenation" and "membrane oxygenation". ---Chapter 2 cites Chinese standards that adopt international standards, not international standards; --- Added Appendix B (informative) "Particle Shedding Reference Test Method". Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the National Standardization Technical Committee of Medical Extracorporeal Circulation Equipment (SAC/TC158). This document was drafted by. Guangdong Medical Device Quality Supervision and Inspection Institute, Ningbo Filar Medical Supplies Co., Ltd., Tianjin Plastic Research Institute Research Institute Co., Ltd., Dongguan Kewei Medical Devices Co., Ltd. The main drafters of this document. Ke Jun, Yuan Qin, Xu Chaosheng, Hong Liangtong, Wu Bijun, Zhang Yun, Shen Lisi, Ye Qing, Hong Huangli, Wu Minyu, Hu Xianghua, Xie Yan, Wen Shaojun. The release status of previous versions of this document and the documents it replaces are as follows. ---First published as YY/T 0730-2009 in.2009; --- This is the first revision.

Introduction

The purpose of formulating this document is to ensure a standard for blood circulation during cardiopulmonary bypass (CPB) and extracorporeal membrane oxygenation (ECMO) procedures. The medical-grade tubing in the tubing kit is used for one-time use for adequate safety and functional testing. Users generally need to provide the details of the pipeline package. Detailed description. In addition, this document also includes guarantees to clarify the characteristics of the piping package in the accompanying documents and production information. It is specified in this document Tubing performance characteristics are provided as part of a disposable tubing kit. The recommended methods given in this document are intended to be used in procedures for evaluating the medical-grade pipeline of CPB therapy and ECMO. introduced for the The test method for the material properties of the body, the service life of the pipeline used in the rolling blood pump and the method of sanitation and cleaning, but there is no test method for these indicators Limits are explained. This document also includes minimum reporting requirements. Existing functional characterization methods can help users to choose the appropriate treatment for patients and related patients according to therapy. medical grade tubing for allergies. This information can inform clinical quality control processes aimed at improving the safety of CPB and ECMO therapy. for help. This document refers to other standards as methods of testing common characteristics of medical devices. This document does not include animal and clinical studies, but the manufacturer's quality system includes these studies. This document only includes requirements corresponding to medical-grade tubing used in CPB and ECMO. For other requirements not specified, you can See some of the other standards listed in the references. Cardiovascular Surgical Implants and Artificial Organs Cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) Requirements for single-use tubing kits

1 Scope

This document specifies the requirements for single-use tubing sets (hereinafter referred to as sets) used in cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). beg. This document applies to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), except that Tubing intended to be used with a blood pump during CPB surgery (short-term, i.e. less than 6h) or ECMO (long-term, i.e. more than 24h) has specific requirements. Sum test method. The provisions of this document regarding sterility and pyrogen-free apply to tubing sets marked "sterile". This document applies only to piping for multifunctional systems that can have complete components such as blood gas exchangers (oxygenators), storage blood vessels, blood microemboli filters, defoamers, blood pumps, etc. Note. This document does not make a special distinction between the terms "membrane oxygenation" and "membrane oxygenation". Refer to "About Printing and Distributing the Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (Trial Eighth Edition) Revised Edition)" (National Health Office Medical Letter [2021] No. 191), "On Printing and Distributing Respiratory Support Therapy and Extracorporeal Membrane Lung for Severe Patients with Novel Coronavirus Pneumonia For the usage of terminology in the "Notice on Guidance Program for Clinical Application of Oxygenation (Trial)" (National Health Office Medical Letter [2020] No. 585), this document generally uses "membrane oxygenation".

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 529 Determination of tear strength of vulcanized rubber or thermoplastic rubber (pants-shaped, right-angled and crescent-shaped specimens) (GB/T 529- 2008, ISO 34-1.2004, MOD) GB/T 1040.1 Determination of tensile properties of plastics - Part 1.General principles (GB/T 1040.1-2018, ISO 527-1.2012, IDT) GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process (GB/T 16886.1- 2011, ISO 10993-1.2009, IDT) GB/T 16886.7 Biological Evaluation of Medical Devices Part 7.Ethylene Oxide Sterilization Residues (GB/T 16886.7-2015, ISO 10993-7.2008, IDT) GB/T 16886.11 Biological Evaluation of Medical Devices Part 11.Systemic Toxicity Test (GB/T 16886.11-2021, ISO 10993-11.2017, IDT) GB 18278.1 Sterilization of medical and healthcare products with moist heat - Part 1.Requirements for the development, validation and routine control of sterilization processes for medical devices Seek (GB 18278.1-2015, ISO 17665-1.2006, IDT) GB 18279.1 Ethylene oxide for sterilization of healthcare products Part 1.Development, validation and routine control of sterilization process for medical devices System requirements (GB 18279.1-2015, ISO 11135-1.2007, IDT) GB 18280.1 Radiation for sterilization of healthcare products Part 1.Requirements for the development, validation and routine control of sterilization processes for medical devices Seek (GB 18280.1-2015, ISO 11137-1.2006, IDT) GB 18280.2 Sterilizing radiation for healthcare products Part 2.Establishing sterilization dose (GB 18280.2-2015, ISO 11137-2.2006, IDT) GB/T.19974 Sterilization characteristics of healthcare products and development, validation and routine control of sterilization process for medical devices

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