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YY/T 0489-2023 English PDF

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YY/T 0489-2023: Sterile drainage catheters and accessory devices for single use
Status: Valid

YY/T 0489: Evolution and historical versions

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 0489-2023	English	679	Add to Cart	6 days [Need to translate]	Sterile drainage catheters and accessory devices for single use	Valid	YY/T 0489-2023
YY 0489-2004	English	359	Add to Cart	3 days [Need to translate]	Sterile drainage catheters and accessory devices for single use	Obsolete	YY 0489-2004

PDF similar to YY/T 0489-2023

Standard similar to YY/T 0489-2023

YY/T 0640 YY/T 0663.2 YY/T 0606.9 YY 0267 YY 0485

Basic data

Standard ID	YY/T 0489-2023 (YY/T0489-2023)
Description (Translated English)	Sterile drainage catheters and accessory devices for single use
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C45
Classification of International Standard	11.040.40
Word Count Estimation	34,337
Date of Issue	2023-11-22
Date of Implementation	2024-12-01
Older Standard (superseded by this standard)	YY/T 0489-2004
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the requirements for single-use sterile drainage catheters, wound and fluid drainage systems, surgical drainage catheters and related components where the catheters are surgically or percutaneously placed into a body cavity or wound for the purpose of removing fluid or air. Drainage outside the body. The drainage catheter is left for natural drainage or connected to a suction source (to accelerate tissue granulation). This standard does not apply to: suction catheters; endotracheal tubes; urinary catheters; ureteral stents, biliary stents and other stents; drainage tubes inserted percutaneously into the digestive tract using gastrostomy; axonal catheters used to remove cerebrospinal fluid; Intestinal catheter used for removing solutions or substances from the gastrointestinal tract; coating.

YY/T 0489-2023: Sterile drainage catheters and accessory devices for single use

---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/T 0489-2004 Disposable sterile drainage catheter and auxiliary equipment (ISO 20697.2018,MOD) Released on 2023-11-22 2024-12-01 implementation The State Drug Administration issued

Preface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Expected Performance 3 5 General requirements 3 6 Special requirements 6 7 Information provided by the manufacturer 8 Appendix A (Informative) Kink stability test method 10 Appendix B (Normative) Corrosion resistance test method 12 Appendix C (normative) Anti-attraction deformation test method 13 Appendix D (normative) Test method for determining the peak tensile force of a connection 14 Appendix E (Normative) Test method for determining the peak tensile force of drainage catheters 15 Appendix F (Normative) Collection device impact test method 17 Appendix G (Normative) Drainage catheter flow measurement test method 18 Appendix H (Informative) Fixing Strength Test Method 20 Appendix I (Normative) Balloon reliability test method 22 Appendix J (normative) Test method for leakage and/or function and/or balloon deflation of the inflated cavity (drainage catheter with compliant balloon) 24 Appendix K (normative) Test method for determining balloon size and retraction reliability (drainage catheter with non-compliant balloon) 25 Appendix L (Normative) Test method for determining the tensile strength of balloons 26 Appendix M (Normative) Test method for leakage resistance during suction or vacuum process 30 Reference 31

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 0489-2004 "Single-use sterile drainage catheters and auxiliary devices" and is consistent with YY/T 0489-2004. In addition to structural adjustments and editorial changes, the main technical changes are as follows. a) Added “risk management” requirements (see 5.1); b) Changed “radio detectability” to “detectability” and modified the corresponding technical contents (see 5.3, 4.4 of the.2004 edition); c) Added “Appearance” requirements (see 5.4); d) Added “size identification” requirements (see 5.5); e) Added “connectors” requirements (see 5.6); f) Added the “Magnetic Resonance Imaging (MRI) Compatibility” requirement (see 5.7); g) The requirement for “sterility” has been changed (see 5.8, 4.8 of the.2004 edition); h) Changed the requirements for "ethylene oxide residue" (see 5.9, 4.8 of the.2004 edition); i) The requirements for “kink stability” have been changed (see 6.1, 4.1 of the.2004 edition); j) "Corrosion test" was changed to "corrosion resistance", and the corresponding technical content was changed (see 6.2, 4.9 of the.2004 edition); k) Changed “breaking force” to “peak tensile force” and changed the corresponding technical content (see 6.4, 4.3 of the.2004 edition); l) Added “flow rate” requirements (see 6.6); m) Added “fixing strength” requirements (see 6.7); n) Added the “balloon reliability” requirement (see 6.8); o) Added the requirement of “integrity and volume maintenance of drainage catheter filling lumen” (see 6.9); p) Added the requirement of “tensile strength of inflated balloon” (see 6.10); q) Changed “marking” and “packaging” to “information provided by the manufacturer” and changed the corresponding technical content (see Chapter 7,.2004 5 and 6 of the.2002 edition); r) Added the normative appendix “Corrosion resistance test method” (see Appendix B); s) Change "Test method for resistance to deformation of drainage system or any component" to "Test method for resistance to deformation by attraction", and change the corresponding technical Technical content (see Appendix C, Appendix A of the.2004 edition); t) Added the normative appendix "Test method for determining the peak tensile force of the connection" (see Appendix D); u) Added the normative appendix "Test method for determining the peak tensile force of drainage catheters" (see Appendix E); v) Added the normative appendix “Drainage catheter flow measurement test method” (see Appendix G); w) Added the normative appendix "Balloon reliability test method" (see Appendix I); x) Added the normative appendix "Test methods for leakage and/or function and/or balloon deflation (Drainage with compliant balloon)" catheter)" (see Appendix J); y) Added the normative appendix "Test method for determining balloon size and retraction reliability (drainage catheters with non-compliant balloons)" (See Appendix K); z) Added the normative appendix "Test method for determining the tensile strength of balloon" (see Appendix L); aa) Added the normative appendix “Test method for leakage resistance during suction or vacuum process” (see Appendix M). This document is modified to adopt ISO 20697.2018 "Single-use sterile drainage catheters and auxiliary devices". The technical differences between this document and ISO 20697.2018 and their reasons are as follows. a) Added the definitions of “compliant balloon” (see 3.18) and “non-compliant balloon” (see 3.19) to improve the applicability of this document; b) Changed the relevant requirements for clinical research in "Risk Management" (see 5.1) to improve the applicability of this document in light of my country's national conditions; c) The requirements for "sterility" (see 5.8) have been changed to improve the applicability of this document in light of my country's national conditions; d) Added the requirement of “ethylene oxide residue” (see 5.9) to protect the health of medical staff and patients. 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 Infusion Equipment (SAC/TC106). This document was drafted by. Shandong Medical Device and Drug Packaging Inspection Institute, Jiangsu Yangtze River Medical Technology Co., Ltd., Beijing Beijing Tiandi Hexie Technology Co., Ltd., Shandong Baiduoan Medical Equipment Co., Ltd., and Bad Medical Technology (Shanghai) Co., Ltd. The main drafters of this document are. Wan Min, Li Yuanyu, Xu Haoyu, Wang Wanming, Zhang Haijun, Shi Kai, Liu Aijuan, Luan Yuanyuan, and Zhu Yixin. The previous versions of this document and the documents it replaces are as follows. ---First published in.2004 as YY/T 0489-2004; ---This is the first revision. Disposable sterile drainage catheter and auxiliary equipment

1 Scope

This document specifies the requirements for single-use sterile drainage catheters, wound and effusion drainage systems, surgical drainage catheters and related components. A catheter is placed surgically or percutaneously in a body cavity or wound to drain fluid or air to the outside of the body. The drainage catheter is left for natural drainage or connected to a suction source (to accelerate tissue granulation). This document does not apply to. ---Suction catheter; ---Tracheal tube; ---Urinary catheter; Note 1.See YY/T 0325. ---Ureteral stents, biliary stents and other stents; Note 2.For requirements on brackets, see ISO 14630 and ASTM F1828-97. --- Drainage tubes inserted percutaneously into the digestive tract using gastrostomy; ---Axonal catheters for removal of cerebrospinal fluid; Note 3.See ISO 20698. ---Intestinal catheters used to remove solutions or substances from the gastrointestinal tract; Note 4.See ISO 20695. ---coating.

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/T 14233.1 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis 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 0615.1 Requirements for labeling “sterile” medical devices Part 1.Requirements for terminally sterilized medical devices YY/T 0916.1 Small-bore connectors for medical liquids and gases Part 1.General requirements (YY/T 0916.1-2021, ISO 80369-1.2018, IDT)

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Accessory device Access and/or drainage devices [e.g., collection devices (3.3)] for use with drainage systems (3.6), and other applicable Accessories, for example, suction sources (3.16), connecting tubes (3.4), connectors, trocars, opening needles/cannulas or introducers.

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