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YY/T 0325-2022: Sterile urethral catheter for single use
Status: Valid YY/T 0325: Evolution and historical versions
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Sterile urethral catheter for single use
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YY/T 0325-2022
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| YY 0325-2016 | English | 150 |
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Sterile urethral catheter for single use
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Basic data | Standard ID | YY/T 0325-2022 (YY/T0325-2022) | | Description (Translated English) | Sterile urethral catheter for single use | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.25 | | Word Count Estimation | 34,382 | | Date of Issue | 2022-08-17 | | Date of Implementation | 2023-09-01 | | Older Standard (superseded by this standard) | YY 0325-2016 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements and test methods for single-use sterile urinary catheters. This standard applies to single-use sterile balloon and non-balloon catheters. This standard does not apply to drainage catheters included in YY 0489, such as ureteral catheters, nephrostomy catheters and suprapubic catheters. This standard also does not apply to ureteral stents. | YY/T 0325-2022: Sterile urethral catheter 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.
Sterile urethral catheter for single use
ICS 11.040.25
CCSC31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0325-2016
Disposable sterile catheter
(ISO 20696.2018, MOD)
Published on 2022-08-17
2023-09-01 Implementation
Released by the State Drug Administration
directory
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Expected performance3
5 General Requirements 3
5.1 Risk Management 3
5.2 Biocompatibility 3
5.3 Detectability 3
5.4 Appearance 3
5.5 Dimensions 3
5.6 MRI Compatibility 5
5.7 Connector 5
5.8 Sterilization5
5.9 Residual content of ethylene oxide (EO)5
6 Special requirements5
6.1 Strength 5
6.2 Connector Security 5
6.3 Balloon reliability 5
6.4 Integrity and volume maintenance of catheter inflated lumen 5
6.5 Flow 6
6.6 Corrosion resistance7
6.7 Kink stability7
6.8 Peak Pull 7
6.9 Inflated Balloon Tensile Resistance 7
7 Information provided by the manufacturer7
7.1 General 7
7.2 Product and/or Packaging Identification7
7.3 Instruction Manual 8
Appendix A (Normative) Test Method for Strength of Urinary Catheter 9
Appendix B (normative) Test method for safety of assembly of drain taper joints 12
Appendix C (Normative) Test Methods for Balloon Reliability 14
Appendix D (normative) Test Methods for Inflation Lumen Leakage and/or Function and/or Balloon Retraction (Catheters with Compliant Balloons) 16
Appendix E (normative) Test Method for Determining Reliability of Balloon Size Retraction (Catheters with Non-Compliant Balloons) 18
Appendix F (normative) Test method for catheter flow measurement 19
Appendix G (normative) Corrosion Resistance Test Method 21
Appendix H (Informative) Kink Stability Test Method 22
Appendix I (normative) Test Method for Determining Peak Tension of Urinary Catheter 24
Appendix J (normative) Test Methods for Determining Balloon Tensile Resistance 25
Reference 28
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 of Standardization Documents"
drafted.
This document replaces YY 0325-2016 "Sterile Urinary Catheter for Disposable Use". Compared with YY 0325-2016, except for structural adjustment and editing
In addition to the editorial changes, the main technical changes are as follows.
---Added the terms "full length", "effective length", "effective tube length", "compliant balloon", "non-compliant balloon", "conical joint"
"Risk", "Risk Analysis", "Risk Assessment", "Risk Management Documentation", "Intermittent", "Coating" and their definitions (see Chapter 3);
--- Increased risk management requirements (see 5.1);
--- Increased requirements for detectability (see 5.3);
--- Added MRI compatibility requirements (see 5.6);
--- Increased the requirements for the integrity and volume maintenance of the catheter inflated lumen (6.4);
--- Added requirements for non-compliant balloons (see 6.4.3);
--- Increased the requirements for peak tension (see 6.8);
--- Increased the requirements for the tensile strength of the inflated balloon (see 6.9);
--- Added the normative appendix "Test method for strength of urinary catheter" (see Appendix A);
--- Added the normative appendix "Test Method for Balloon Reliability" (see Appendix C);
--- Added the normative appendix "Test method for catheter flow measurement" (see Appendix F);
--- Added the normative appendix "Corrosion Resistance Test Method" (see Appendix G);
--- Added the normative appendix "Test method for measuring the peak pulling force of the urinary catheter" (see Appendix I);
--- Added the normative appendix "Test method for measuring the tensile strength of balloons" (see Appendix J).
This document is modified to adopt ISO 20696.2018 "Single-use sterile urinary catheters".
Compared with ISO 20696.2018, this document has the following structural adjustments.
--- Adjusted the order of terms and definitions in Chapter 3;
---Appendix E, Appendix F, Appendix G, Appendix H, Appendix I correspond to Appendix I, Appendix E, Appendix F,
Appendix G, Appendix H.
The technical differences between this document and ISO 20696.2018 and their reasons are as follows.
--- Added normative reference document GB/T 14233.1;
--- Added normative reference document YY/T 0615.1;
--- Added the term "nominal balloon volume" and its definition (see 3.7);
--- Increased residual ethylene oxide (EO) (see 5.9).
Please note that some content of this document may be patented. 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 Technical Committee on Standardization of Medical Infusion Devices (SAC/TC106).
This document was drafted by. Shandong Institute of Medical Device and Drug Packaging Inspection, Guangzhou Weili Medical Device Co., Ltd., Guangdong
Baihe Medical Technology Co., Ltd., Braun Medical (Shanghai) International Trade Co., Ltd., Hangzhou Tuoaimu Medical Equipment Co., Ltd., Kangwei
Germany (China) Medical Products Co., Ltd., Jiangsu Suyun Medical Equipment Co., Ltd.
The main drafters of this document. Zhang Limei, Yu Kelong, Liu Jing, Hu Qiaoling, Pan Muqiu, Wang Changbin, Wang Niu, Li Cong, Meng Kai, Wu Meihua.
The previous versions of this document and its superseded documents are as follows.
---First published in.2002 as YY 0325-2002, first revised in.2016;
---This is the second revision.
Introduction
YY/T 0325 was first published in.2002.When it was first revised in.2016, reference was made to EN1616.1997/A1.1999 "Disposable
Use a sterile catheter". At that time, based on the current status of catheter product technology and the indwelling time of clinical catheters, 4.7 resistance in YY 0325-2016
Bendability is only specified in the catheter test method for long-term ( >1h) use. With the development of clinical needs and technology, intermittent catheterization has emerged.
product, the longest time it touches the patient's urethra is only a few minutes.
In.2018, ISO 20696.2018 was released, and EN1616.1997/A1.1999 was also replaced by ENISO 20696.2018.This repair
Ordered and revised to adopt ISO 20696.2018, adding requirements and test methods for intermittent urinary catheters.
Disposable sterile catheter
1 Scope
This document specifies requirements and test methods for single-use sterile urinary catheters.
This document applies to single-use sterile balloon and non-balloon catheters.
This document does not apply to drainage catheters included in YY 0489, such as ureteral catheters, nephrostomy catheters and suprapubic catheters. This document also
Not suitable for ureteral stents.
Note. YY/T 0872 specifies the test methods for ureteral stents.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
GB/T 14233.1 Test 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 Risk Management Process (GB/T 16886.1-
2011, ISO 10993-1.2009, IDT)
YY/T 0316 Application of Medical Device Risk Management to Medical Devices (YY/T 0316-2016, ISO 14971.2007 Correction
version, IDT)
YY/T 0615.1 Requirements for labelling "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
urinary catheter urethralcatheter
A tubular device inserted through the urethra into the bladder for the purpose of voiding, drug delivery, and/or bladder irrigation.
3.2
Outside diameter outsidediameter
The largest dimension measured on the vertical section of the tube body.
3.3
full length overalllength
L2
The total length from the tip of the conduit to the end of the tapered fitting (3.10).
3.4
effectivelength effectivelength
L1
The length of the catheter that can be inserted into the body.
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