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YY 0339-2009

YY 0339-2009_English: PDF (YY0339-2009)
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YY 0339-2009English215 Add to Cart 0--10 minutes. Auto-delivered. Suction catheter for use in the respiratory tract YY 0339-2009 Obsolete YY 0339-2009
 

BASIC DATA
Standard ID YY 0339-2009 (YY0339-2009)
Description (Translated English) Suction catheter for use in the respiratory tract
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C31
Classification of International Standard 11.040.10
Word Count Estimation 14,113
Date of Issue 2009-06-16
Date of Implementation 2010-12-01
Older Standard (superseded by this standard) YY 0339-2002
Quoted Standard GB/T 16886.1; GB/T 19633; YY 0466; YY/T 0586-2005; YY/T 0615.1-2007; EN 1041
Adopted Standard ISO 8836-2007, MOD
Drafting Organization Jiangsu Province Medical Device Testing
Administrative Organization Jinan, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center
Regulation (derived from) Industry standard filing Notice 2009 No. 9
Proposing organization State Food and Drug Administration
Issuing agency(ies) China Food and Drug Administration
Summary This standard specifies the respiratory suction catheter with a plastic manufacturing requirements. Special aspiration catheter, if there is no end to attract multi-lumen catheter holes, not included in the scope of this standard. Suction head is curved catheter (eg Coud�� catheters) are not considered special aspiration catheter, therefore included in the standard range.

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.