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YY 0339-2009 (YY/T 0339-2019 Newer Version) PDF English


YY 0339-2009 (YY0339-2009) PDF English
Standard IDContents [version]USDSTEP2[PDF] delivered inName of Chinese StandardStatus
YY/T 0339-2019English505 Add to Cart 0-9 seconds. Auto-delivery. Suction catheters for use in the respiratory tract Valid
YY 0339-2009English230 Add to Cart 0-9 seconds. Auto-delivery. Suction catheter for use in the respiratory tract Obsolete
YY 0339-2002English479 Add to Cart 3 days Suction catheter for use in the respiratory tract Obsolete
Newer version: YY/T 0339-2019     Standards related to (historical): YY/T 0339-2019
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YY 0339-2009: PDF in English

YY 0339-2009 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.10 C 31 Replacing YY 0339-2002 Suction Catheter for Use in the Respiratory Tract (ISO 8836:2007, MOD) ISSUED ON: JUNE 16, 2009 IMPLEMENTED ON: DECEMBER 1, 2010 Issued by: China Food and Drug Administration Table of Contents Foreword ... 3  Introduction ... 4  1 Scope ... 5  2 Normative References ... 5  3 Terms and Definitions ... 5  4 Specification Marking and Dimensions ... 7  5 Materials ... 8  6 Design ... 9  7 Performance Requirements ... 11  8 Requirements for Aseptically Supplied Suction Catheter ... 12  9 Marking ... 12  Appendix A (normative) Test Method of Connection Fastness ... 15  Appendix B (normative) Test Method of Residual Vacuum ... 16  Appendix NA (informative) Technical Differences between this Standard and ISO 8836:2007 and Their Causes ... 18  Bibliography ... 19  Suction Catheter for Use in the Respiratory Tract 1 Scope This Standard specifies the requirements for plastics-made suction catheter for use in the respiratory tract. Special suction catheters, for example, multi-lumen suction catheters without terminal orifices, are not included in the scope of this Standard. Suction catheters with curved heads (for example, catheter) are not considered as special suction catheters, and, are therefore included in the cope of this Standard. 2 Normative References Through the reference in this Standard, clauses of the following documents become clauses of this Standard. In terms of references with a specific date, all the subsequent modification sheets (excluding the corrected content) or the revised editions are not applicable to this Standard. However, all parties that reach an agreement in accordance with this Standard are encouraged to explore the possibility of adopting the latest version of these documents. In terms of references without a specific date, the latest version is applicable to this Standard. GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing (GB/T 16886.1-2001, idt ISO 10993-1:1997) GB/T 19633 Packaging for Terminally Sterilized Medical Devices (GB/T 19633-2005, ISO 11607:2003, IDT) YY 0466 Medical Devices - Symbols to be Used with Medical Device Labels Labelling and Information to be Supplied (YY 0466-2003, ISO 15223:2000, IDT) YY/T 0586-2005 Medical Polymer Products - Test Methods of Radiopacity YY/T 0615.1-2007 Requirements for Medical Devices to be Designated STERILE - Part 1: Requirements for Terminally Sterilized Medical Devices EN 1041 Information Supplied by the Manufacturer of Medical Devices 3 Terms and Definitions The following terms and definitions are applicable to this document. 3.1 Adaptor Adaptor refers to a special joint for the establishment of functional continuity among different or unmatched parts. 3.2 Connector Connector refers to an adapting piece for the connection of two or more parts. 3.3 Eye Eye refers to side hole near the patient end of a catheter. 3.4 Machine End Machine end refers to an end of catheter used to connect to the vacuum source. 3.5 Patient End Patient end refers to an end of catheter used to intubate patient. 3.6 Residual Vacuum Residual vacuum refers to the negative pressure at the patient end of catheter when vacuum control device is in the release position. 3.7 Shaft Shaft refers to the main part of catheter with consistent outer diameter. 3.8 Suction Catheter Suction catheter refers to a flexible shaft (3.7) with a machine end (3.4) and a patient end (3.5) used in the respiratory tract for the suction of tracheobronchial secretions. 3.9 Terminal Orifice Terminal orifice the central opening of the patient end of suction catheter. 3.10 Tip Tip refers to end tail end of the patient end of suction catheter. 3.11 Vacuum Control Device Vacuum control device refers to a device for controlling air flow and aspirate at or near the machine end of catheter. endotracheal tubes, tracheotomy tubes and corresponding connectors. Conduct visual inspection. 5.4 The external surface of shaft should be bright and clean, which can reduce surface friction. 5.5 The materials used to manufacture suction catheter should make the wall thickness of suction catheter as thin as possible. Meanwhile, maintain its resistance to flattening and kinking. 5.6 Under normal use conditions, suction catheter should be sufficient to resist the erosion of anesthesia steam and gas. 6 Design 6.1 Lumen The inner diameter of lumen in any part between the machine end and the eye closest to the machine end shall be not less than the inner diameter of the shaft at the eye. 6.2 Patient End 6.2.1 Suction catheter whose tip cannot be observed during use, or, suction catheter which is used for suction system with a vacuum pressure of more than 40 cmH2O (3.92 kPa) shall have terminal orifice. In addition, there shall be a side orifice within a distance of at least 2 cm from the terminal orifice. 6.2.2 In terms of suction catheter whose tip can be observed during use, or, suction catheter which is used for suction system with a vacuum pressure of 0 cmH2O (0 kPa) ~ 40 cmH2O (3.92 kPa), side orifice is not required. 6.2.3 The aperture of terminal orifice shall be not less than 90% of inner diameter of catheter. 6.2.4 The tip and side orifice shall be smooth. Conduct visual inspection. 6.2.5 The side orifice should not trigger kinking or flattening of suction catheter during the process of using. 6.2.6 The axis of the patient end may form an included angle with the long axis of the shaft (see -type catheter tip in Figure 1). 6.3 Machine End 6.3.1 The machine end of suction catheter shall be permanently connected to the shaft and satisfy the requirements in 7.1. (or X-ray radiopaque marking) shall be not less than 0.10. 7.3 Vacuum Control Device When suction catheter with permanently connected vacuum control device is tested in accordance with Appendix B, the residual vacuum shall not exceed 0.33 kPa (3.4 cmH2O). 8 Requirements for Aseptically Supplied Suction Catheter 8.1 Sterility Assurance Aseptically supplied suction catheter with designated “STERILE” shall comply with the requirements of 4.1 in YY/T 0615.1-2007. 8.2 Packaging of Aseptically Supplied Suction Catheter 8.2.1 Each aseptically supplied suction catheter with designated “STERILE” shall adopt single package. 8.2.2 In accordance with GB/T 19633, single package shall effectively prevent the entry of microorganisms and particles. 8.2.3 Single package shall allow the contents to be aseptically taken out, and once opened, it cannot be closed again. Otherwise, there will be signs of opening. 8.2.4 Each single package shall be packed in a shelf container or a multi-unit packaging container. 9 Marking 9.1 Marking of Suction Catheter 9.1.1 The marking of suction catheter shall comply with EN 1041. 9.1.2 In accordance with 4.1, suction catheter shall mark the nominal outer diameter. Suction catheter may additionally provide French specification [see 4.1.1 a]]. 9.1.3 In terms of pediatric suction catheter with a smaller specification, the manufacturer should additionally mark the distance or segment from the patient end in centimeters. 9.1.4 The machine end of suction catheter with a turning at the patient end shall have a mark that indicates the direction of the end point. 9.2 Application of Symbols Corresponding symbols provided in YY 0466 may satisfy the requirements in 9.3 and 9.4. 9.3 Marking of Single Package 9.3.1 The marking of single package shall comply with EN 1041. 9.3.2 Single package shall have the following marking: a) Description of contents; b) Specification marked in accordance with 4.1.1; expressed in one or two of the following example forms: 6 mm  500 mm, or, 6 mm (18 F)  500 mm; c) The manufacturer and / or supplier’s name and / or trademark; d) Lot No.; e) If appropriate, provide the expiration date of suction catheter, expressed in month and year; f) The designation “STERILE” (if it is sterile) and sterilization method; g) In terms of suction catheter that is not expected to be reused, the designation “SINGLE-USE” or equivalent instructions; h) The designation “X-RAY DETECTABLE” or equivalent instructions, if applicable. 9.4 Shelf Container or Multi-pack Container 9.4.1 The marking of shelf container or multi-pack container shall comply with EN 1041. 9.4.2 On shelf container or multi-pack container, there shall be marking as follows: a) Description of contents; b) Specification marked in accordance with 4.1.1; expressed in one or two of the following example forms: 6 mm  500 mm, or, 6 mm (18 F)  500 mm; c) The manufacturer and / or supplier’s name and / or trademark; d) Lot No.; e) If appropriate, provide the expiration date of suction catheter, expressed in month and year; Appendix A (normative) Test Method of Connection Fastness A.1 Principle Apply an axial separation force between each part of suction catheter and the shaft, so as to examine the fastness of any parts that are permanently connected to the shaft. A.2 Instruments A.2.1 Suction catheter conditioning device, temperature: 23 °C ± 2 °C; relative humidity: 50% ± 20%. Conduct the test under the same conditions. A.2.2 Test device which applies a separation force between test parts of suction catheter. It is able to separate them at the rate of 200 mm/min ± 20 mm/min. Measure and record the applied axial separation force. A.3 Procedures A.3.1 Place the suction catheter for 1 h under the conditions: temperature: 23 °C ± 2 °C and relative humidity: 50% ± 20%. Conduct the test under the same conditions. A.3.2 At the rate of 200 mm/min ± 20 mm/min, apply a separation force onto catheter component. Observe whether the component is separated from the shaft before the applied force reaches the corresponding minimum force value specified in Table 2. A.4 Result Expression Record whether component is separated from the shaft before the applied force reaches the corresponding minimum force value specified in Table 2. Appendix B (normative) Test Method of Residual Vacuum B.1 Principle Place the vacuum control device in the release position. At the machine end of catheter, apply suction. Through the measurement of residual vacuum at the catheter tip, verify the effectiveness of the vacuum control device on the machine end in releasing vacuum. B.2 Instruments B.2.1 Flowmeter: able to measure flow at 30 L/min, with an accuracy of ± 5%. At 30 L/min, resistance to airflow is less than 0.1 kPa. B.2.2 Adjustable vacuum pump. B.2.3 Differential pressure gauge, with an accuracy of ± 0.01 kPa (0.1 cmH2O). B.3 Procedures B.3.1 In accordance with Figure B.1, connect the various instruments. Install the flowmeter at the air inlet of the vacuum pump. Ensure the airtight assembly of the catheter and the differential pressure gauge. B.3.2 Turn the catheter vacuum control device to the release position. B.3.3 Turn on the vacuum pump; adjust the applied vacuum, till the flow indicated by the flowmeter is 30 L/min. B.4 Result Expression Use the residual vacuum value measured on the differential pressure gauge to represent the result, expressed in kPa. ......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.