YY/T 0339-2024_English: PDF (YY/T0339-2024)
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0339-2024 | English | RFQ |
ASK
|
3 days [Need to translate]
|
(Airway suction catheter)
| Valid |
YY/T 0339-2024
|
| YY/T 0339-2019 | English | 505 |
Add to Cart
|
0--9 seconds. Auto-delivery
|
Suction catheters for use in the respiratory tract
| Valid |
YY/T 0339-2019
|
| YY 0339-2009 | English | 230 |
Add to Cart
|
0--9 seconds. Auto-delivery
|
Suction catheter for use in the respiratory tract
| Obsolete |
YY 0339-2009
|
| YY 0339-2002 | English | 479 |
Add to Cart
|
3 days [Need to translate]
|
Suction catheter for use in the respiratory tract
| Obsolete |
YY 0339-2002
|
| Standard ID | YY/T 0339-2024 (YY/T0339-2024) | | Description (Translated English) | (Airway suction catheter) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Date of Issue | 2024-09-29 | | Date of Implementation | 2025-10-15 | | Older Standard (superseded by this standard) | YY/T 0339-2019 | | Summary | This standard specifies the dimensions and requirements of suction catheters for respiratory tract. This standard applies to open and closed suction catheters made of flexible materials and intended for respiratory tract suction. This standard does not apply to suction catheters intended for use with flammable anesthetic gases or agents, lasers or electrosurgical equipment. | | Standard ID | YY/T 0339-2019 (YY/T0339-2019) | | Description (Translated English) | Suction catheters for use in the respiratory tract | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Word Count Estimation | 30,380 | | Date of Issue | 2019 | | Date of Implementation | 2020-06-01 | | Summary | This standard specifies requirements for suction catheters made of flexible materials intended for use in the respiratory tract, including open and closed suction catheters. This standard applies to suction catheters with curved tips (such as Coudé catheters), or suction catheters with suction collectors, which are not considered special suction catheters. This standard does not apply to suction catheters intended for use with flammable anesthetic gases or agents, lasers or electrosurgical equipment. | | 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/T 0339-2019
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.10
C 46
Replacing YY 0339-2009
Suction Catheters for Use in the Respiratory Tract
(ISO 8836:2014, MOD)
ISSUED ON: MAY 31, 2019
IMPLEMENTED ON: JUNE 01, 2020
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 4
Introduction ... 7
1 Scope ... 8
2 Normative References ... 8
3 Terms and Definitions ... 10
4 General Requirements for Open and Closed Suction Catheters* ... 14
4.1 Risk management ... 14
4.2 Safety ... 14
5 Specific Requirements for Open and Closed Suction Catheters ... 15
5.1 Size and length designations ... 15
5.2 Dimensions* ... 16
6 Materials ... 16
7 Design ... 17
7.1 Lumen of the suction catheter ... 17
7.2 Suction catheter tip ... 17
7.3 Suction catheter connector ... 18
7.4 Additional requirements for closed suction catheters ... 19
7.4.1 General design ... 19
7.4.2 Patient end adaptor and connectors for the closed suction catheter ... 20
7.4.3 Protective sleeve ... 21
7.4.4 Vacuum control device for closed suction catheters ... 22
7.4.5 Flushing system for closed suction catheters ... 22
7.4.6 T-piece cap ... 22
8 Performance Requirements ... 22
8.1 Security of construction ... 22
8.2 Shaft performance ... 23
8.3 Vacuum control device performance* ... 23
8.4 Leakage*... 23
8.5 Resistance to flow* ... 24
8.6 Radiopacity* ... 24
9 Requirements for Suction Catheters Supplied Sterile ... 24
9.1 Sterility assurance ... 24
9.2 Packaging of suction catheters supplied sterile ... 24
10 Marking ... 25
10.1 Marking on suction catheters ... 25
10.2 Use of symbols ... 26
10.3 Labelling of individual packs ... 26
10.4 Labelling of shelf/multi-unit packs... 27
Annex A (Informative) Rationale ... 29
Annex B (Normative) Test Method for Security of Attachment ... 33
Annex C (Normative) Measurement of Residual Vacuum ... 34
Annex D (Normative) Method of Testing Leakage... 36
Annex E (Informative) Hazard Identification for Risk Assessment ... 37
Bibliography ... 40
Foreword
This Standard was drafted as per the rules specified in GB/T 1.1-2009.
This Standard replaced YY 0339-2009 Suction Catheters for Use in the Respiratory
Tract. Compared with YY 0339-2009, the major technical changes besides the editorial
modifications of this Standard are as follows:
--- Add the requirements for the closed suction catheter (see 7.4 of this Standard);
--- Modify the requirements for the therapy ventilator (see 8.4 and 8.5 of this
Standard);
--- Modify the requirements for the risk management (see 4.1 of this Standard);
--- According to ISO 8836, correct the instructions for the Positions 1 and 2 in Figure
C.1 (see Figure C.1 of this Standard; Figure B.1 in YY 0339-2009).
This Standard uses the re-drafting method to modify and adopt the international
standard ISO 8836:2014 Suction Catheters for Use in the Respiratory Tract (English
Version).
Compared with ISO 8836:2014, the major technical differences of this Standard are as
follows:
--- Regarding the normative references, this Standard made the adjustments in
technical differences, so as to adapt to China’s technical conditions. The
adjustments were centrally reflected in Clause 2 “Normative References”; the
specific adjustments are as follows:
⚫ Use the national standard GB/T 1962.1 to replace the international standard
ISO 594-1 (see 7.4.5);
⚫ Use the national standard GB/T 1962.2 to replace the international standard
ISO 594-2 (7.4.5);
⚫ Use the national standard GB/T 4999 to replace the international standard
ISO 4135:2001 (see Clause 3);
⚫ Use the national standard GB/T 9706.1 to replace the international standard
IEC 60601-1:2005 (see 10.2);
⚫ Use the national standard GB/T 16273.1 to replace the international
standard of ISO 7000 (see 10.2);
⚫ Use the national standard GB/T 16886.1 to replace the international
standard ISO 10993-1 (see 6.1);
⚫ Use the national standard GB/T 19633.1 to replace the international
standard ISO 11607-1 (see 9.2.2);
⚫ Use the national standard GB/T 19633.2 to replace the international
standard ISO 11607-2 (see 9.2.2);
⚫ Use the industry standard YY/T 0316 to replace the international standard
ISO 14971:2007 (see 4.1.1);
⚫ Use the industry standard YY/T 0466.1 to replace the international standard
ISO 15223-1 (see 10.2);
⚫ Use the industry standard YY/T 0466.2 to replace the international standard
ISO 15223-2 (see 10.2);
⚫ Use the industry standard YY 0636.1 to replace the international standard
ISO 10079-1 (see 7.3.1 and 7.3.6);
⚫ Use the industry standard YY 0636.2 to replace the international standard
ISO 10079-2 (see 7.3.1 and 7.3.6);
⚫ Use the industry standard YY 0636.3 to replace the international standard
ISO 10079-3 (see 7.3.1 and 7.3.6);
⚫ Use the industry standard YY/T 1040.1 to replace the international standard
ISO 5356-1 (see 7.3.5, 7.4.2.1 and 7.4.2.2).
Compared with ISO 8836:2014, the editorial modifications of this Standard are as
follows:
--- The instructions of major differences between ISO 8836:2014 and the former
edition are transferred to this Foreword;
--- Correct the editorial errors in ISO 8836:2004;
⚫ Change the sub-clause number from 7.3.6, 7.3.7 and 7.3.8 to 7.3.5, 7.3.6,
and 7.3.7;
⚫ Transfer the normative reference ISO 4135:2001 from the Bibliography to
Clause 2 Normative References;
⚫ Transfer the non-normative reference IEC 62366-1 from Clause 2 Normative
References to the Bibliography; which is replaced by the corresponding
industry standard YY/T 1474.
Suction Catheters for Use in the Respiratory Tract
1 Scope
This Standard specifies requirements for suction catheters, including open and closed
suction catheters, made of flexible materials and intended for use in suctioning of the
respiratory tract.
Angled-tip suction catheters (e.g.: catheters) and suction catheters with
aspirator collectors are not considered to be specialized and are therefore included in
the scope of this Standard.
Suction catheters intended for use with flammable anaesthetic gases or agents, lasers
or electrical surgical equipment are not covered by this Standard.
NOTE: See ISO/TR 11991 [6] for guidance on airway management during laser surgery of the
upper respiratory tract.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) is applicable to this document.
GB/T 1962.1 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and
Certain other Medical Equipment - Part 1: General Requirement (GB/T 1962.1-
2015, ISO 594-1:1986, IDT)
GB/T 1962.2 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and
Certain other Medical Equipment - Part 2: Lock Fittings (GB/T 1962.2-2001, ISO
594-2:1998, IDT)
GB/T 4999 Anaesthetic and respiratory equipment – Vocabulary (GB/T 4999-
2003, ISO 4135:2001, IDT)
GB 9706.1 Medical Electrical Equipment - Part 1: General Requirements for
Safety (GB 9706.1-2007, IEC 60601-1:1988, IDT)
GB/T 16273.1 Graphical Symbols for Use on Equipment - Part 1: Common
Symbols (GB/T 16273.1-2008, ISO 7000:2004, NEQ)
GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and
Testing within a Risk Management Process (GB/T 16886.1-2011, ISO 10993-
1:2009, IDT)
GB/T 19633.1 Packaging for Terminally Sterilized Medical Devices - Part 1:
Requirements for Materials, Sterile Barrier Systems and Packaging Systems
(GB/T 19633.1-2015, ISO 11607-1:2006, IDT)
GB/T 19633.2 Packaging for Terminally Sterilized Medical Devices - Part 2:
Validation Requirements for Forming, Sealing and Assembly Processes (GB/T
19633.2-2015, ISO 11607-2:2006, IDT)
YY/T 0316 Medical Devices – Application of Risk Management to Medical
Devices (YY/T 0316-2016, ISO 14971:2007, IDT)
YY/T 0466.1 Medical Devices - Symbols to be Used with Medical Device Labels,
Labelling and Information to be Supplied - Part 1: General Requirements (YY/T
0466.1-2016, ISO 15223-1:2007, IDT)
YY/T 0466.2 Medical Devices - Symbols to be Used with Medical Device Labels,
Labelling and Information to be Supplied - Part 2: Symbol Development, Selection
and Validation (YY/T 0466.2-2015, ISO 15223-2:2010, IDT)
YY 0636.1 Medical Suction Equipment - Part 1: Electrically Powered Suction
Equipment - Safety Requirements (YY 0636.1-2008, ISO 10079-1:1999, MOD)
YY 0636.2 Medical Suction Equipment - Part 2: Manually Powered Suction
Equipment (YY 0636.2-2008, ISO 10079-2:1999, IDT)
YY 0636.3 Medical Suction Equipment - Part 3: Suction Equipment Powered from
a Vacuum or Pressure Source (YY 0636.3-2008, ISO 10079-3:1999, IDT)
YY/T 1040.1 Anaesthetic and Respiratory Equipment - Conical Connectors - Part
1: Cones and Sockets (YY/T 1040.1-2015, ISO 5356-1:2004, IDT)
ISO 5367:2014 Anaesthetic and Respiratory Equipment – Breathing Sets and
Connectors
ISO 11135 Sterilization of Health-Care Products – Ethylene Oxide –
Requirements for the Development, Validation and Routine Control of a
Sterilization Process for Medical Devices
ISO 11137-1 Sterilization of Health-Care Products – Radiation – Part 1:
Requirements for Development, Validation and Routine Control of a Sterilization
Process for Medical Devices
ISO 14155 Clinical Investigation of Medical Devices for Human Subjects – Good
......
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.
......
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