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YY/T 0339-2019

Chinese Standard: 'YY/T 0339-2019'
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YY/T 0339-2019English589 Add to Cart Days<=5 Suction catheters for use in the respiratory tract Valid YY/T 0339-2019
YY/T 0339-2019Chinese24 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
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 30,313
Date of Issue 2019-05-31
Date of Implementation 2020-06-01
Drafting Organization Shanghai Medical Device Testing Institute, Jiangsu Medical Device Testing Institute, Guangzhou Weili Medical Devices Co., Ltd.
Administrative Organization National Technical Committee for Standardization of Anesthesia and Respiratory Equipment (SAC/TC 116)
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

YY/T 0339-2019
Suction catheters for use in the respiratory tract
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0339-2009
Respiratory catheter
(ISO 8836.2014, MOD)
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Content
Foreword III
Introduction V
1 range 1
2 Normative references 1
3 Terms and Definitions 2
4 General requirements for open and closed suction catheters 5
4.1 Risk Management 5
4.2 Security 5
5 Open and closed suction catheters special requirements 5
5.1 Specifications and length identification 5
5.2 Size 6
6 Material 6
7 Design 7
7.1 Attracting the catheter lumen 7
7.2 Attracting the catheter tip 7
7.3 Suction conduit connector 8
7.4 Closed suction catheters Additional requirements 9
7.4.1 Universal Design 9
7.4.2 Closed suction catheter patient end adapters and fittings 10
7.4.3 Protective cover 10
7.4.4 Vacuum control device for closed suction catheters 10
7.4.5 Flushing system for closed suction catheters 10
7.4.6 T-type cap 10
8 Performance requirements 11
8.1 Connection Fastness 11
8.2 Tube Performance 11
8.3 Vacuum control device performance 11
8.4 Leak 11
8.5 air resistance 12
8.6 Radiopacity 12
9 Requirements for suction catheters provided in sterile form 12
9.1 Sterility 12
9.2 Sterile supply of suction catheters 12
10 mark 12
10.1 Marking of the suction catheter 12
10.2 Use of symbols 14
10.3 Individually packaged labels 14
10.4 Labels for shelf/multi-unit packaging 14
Appendix A (informative) Basic Principles 15
Appendix B (Normative) Test Method for Connection Fastness 18
Appendix C (Normative Appendix) Residual Vacuum Test Method 19
Appendix D (Normative Appendix) Test Method for Leaks 20
Appendix E (informative) Hazard Identification for Risk Assessment 21
Reference 23
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0339-2009 "Attraction catheter for respiratory tract", compared with YY 0339-2009, except for editorial changes
The technical changes are as follows.
--- Increased requirements for closed suction catheters (see 7.4);
--- Revised the requirements for the treatment of ventilators (see 8.4 and 8.5);
--- Revised the requirements for risk management (see 4.1);
--- According to ISO 8836, the position description of 1, 2 in Figure C.1 is corrected (see Figure C.1, Figure B.1 in YY 0339-2009).
This standard uses the redrafting method to modify the international standard ISO 8836.2014 "Attraction catheter for respiratory tract" (English version).
The main technical differences between this standard and ISO 8836.2014 are as follows.
---About the normative reference documents, this standard has been technically adjusted to adapt to China's technical conditions, adjustments
The situation is reflected in Chapter 2, “Regulatory Citations”, and the specific adjustments are as follows.
● Replace the international standard ISO 594-1 with the national standard GB/T 1962.1 (see 7.4.5);
● Replace the international standard ISO 594-2 with the national standard GB/T 1962.2 (see 7.4.5);
● Replace the international standard ISO 4135.2001 with the national standard GB/T 4999 (see Chapter 3);
● Replace the international standard IEC 60601-1.2005 with the national standard GB 9706.1 (see 10.2);
● Replace the international standard ISO 7000 with the national standard GB/T 16273.1 (see 10.2);
● Replace the international standard ISO 10993-1 with the national standard GB/T 16886.1 (see 6.1);
● Replace the international standard ISO 11607-1 with the national standard GB/T 19633.1 (see 9.2.2);
● Replace the international standard ISO 11607-2 with the national standard GB/T 19633.2 (see 9.2.2);
● Replace the international standard ISO 14971.2007 with the industry standard YY/T 0316 (see 4.1.1);
● Replace the international standard ISO 15223-1 with the industry standard YY/T 0466.1 (see 10.2);
● Replace the international standard ISO 15223-2 with the industry standard YY/T 0466.2 (see 10.2);
● Replace the international standard ISO 10079-1 with the industry standard YY 0636.1 (see 7.3.1 and 7.3.6);
● Replace the international standard ISO 10079-2 with the industry standard YY 0636.2 (see 7.3.1 and 7.3.6);
● Replace the international standard ISO 10079-3 with the industry standard YY 0636.3 (see 7.3.1 and 7.3.6);
• Replace the international standard ISO 5356-1 with the industry standard YY/T 1040.1 (see 7.3.5, 7.4.2.1 and 7.4.2.2).
Compared with ISO 8836.2014, this standard has the following editorial changes.
--- Move the description of the main differences between ISO 8836.2014 and the previous version to this preface;
--- Fixed an editorial bug in ISO 8836.2014.
● Articles 7.3.6, 7.3.7 and 7.3.8 are changed to 7.3.5, 7.3.6 and 7.3.7 respectively;
• Move the normatively referenced document ISO 4135.2001 from the reference to the Chapter 2 normative reference;
● Move the non-normatively referenced document IEC 62366-1 from Chapter 2 normative references to the reference and use
Should be replaced by the industry standard YY/T 1474.
--- Removed the normative references ISO 594-1 and ISO 594-2 in Chapter 2 of Appendix A to be ISO 80369-7
Alternative instructions.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Anesthesia and Respiratory Equipment (SAC/TC116).
This standard was drafted. Shanghai Medical Device Testing Institute, Jiangsu Medical Device Testing Institute, Guangzhou Weili Medical Devices Co., Ltd.
the company.
The main drafters of this standard. Fu Guoqing, Qin Li, Huang Kaigen, Zhu Yu, Chen Tao.
introduction
This standard specifies the size and requirements of the suction catheter for the respiratory tract. Also includes an open suction tube made of a flexible material and
Basic requirements and confirmation methods for the specifications of closed suction catheters.
In order to help medical personnel to better select the most suitable suction catheter for a specific patient in clinical application, it is proposed to attract the catheter outside the catheter.
Description of the shape and size. The size of the suction catheter is determined by the outer diameter of the suction catheter. The outer diameter of the suction catheter is important because
The diameter determines whether the suction catheter can be well matched when used in conjunction with an endotracheal tube or a tracheostomy tube.
See Appendix A for an explanation of the contents of the standard with an asterisk (*).
Respiratory catheter
1 Scope
This standard specifies the requirements for suction catheters made of flexible materials intended for the respiratory tract, including open and closed suction.
catheter.
This standard applies to suction catheters with a pointed tip (such as Coudé catheters) or suction catheters with suction collectors.
The suction catheter is not considered to be a special suction catheter.
This standard does not apply to suction catheters intended for use with flammable anesthetic gases or pharmaceutical, laser or electrosurgical devices.
Note. Guidance documents for upper airway laser surgery airway management can be found in ISO /T R11991 [6].
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 1962.1 syringes, needles and other medical devices 6% (Ruhr) conical joints - Part 1. General requirements
(GB/T 1962.1-2015, ISO 594-1.1986, IDT)
GB/T 1962.2 syringes, needles and other medical devices 6% (Ruhr) conical joints Part 2. Locking joints
(GB/T 1962.2-2001, ISO 594-2..1998, IDT)
GB/T 4999 Anesthesia breathing equipment terminology (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 equipment - Part 1. General symbols (GB/T 16273.1-2008, ISO 7000.2004,
NEQ)
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (GB/T 16886.1-
2011, ISO 10993-1..2009, IDT)
GB/T 19633.1 End-sterilized medical device packaging - 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 of terminally sterilized medical devices - Part 2. Requirements for confirmation of forming, sealing and assembly processes
(GB/T 19633.2-2015, ISO 11607-2.2006, IDT)
YY/T 0316 Medical Device Risk Management for Medical Devices (YY/T 0316-2016, ISO 14971.2007,
IDT)
YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements
(YY/T 0466.1-2016, ISO 15223-1.2007, IDT)
YY/T 0466.2 Medical devices for the labeling, marking and the provision of information for medical devices - Part 2. Development of symbols,
Selection and confirmation (YY/T 0466.2-2015, ISO 15223-2.2010, IDT)
YY 0636.1 Medical suction equipment - Part 1. Safety requirements for electric suction equipment (YY 0636.1-2008, ISO 10079-1.
1999, MOD)
YY 0636.2 Medical suction equipment Part 2. Manually driven suction equipment (YY 0636.2-2008, ISO 10079-2.1999,
IDT)
YY 0636.3 Medical suction equipment - Part 3. Suction equipment powered by negative pressure or pressure source (YY 0636.3-2008,
ISO 10079-3.1999, IDT)
YY/T 0339-2019
Suction catheters for use in the respiratory tract
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0339-2009
Respiratory catheter
(ISO 8836.2014, MOD)
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Content
Foreword III
Introduction V
1 range 1
2 Normative references 1
3 Terms and Definitions 2
4 General requirements for open and closed suction catheters 5
4.1 Risk Management 5
4.2 Security 5
5 Open and closed suction catheters special requirements 5
5.1 Specifications and length identification 5
5.2 Size 6
6 Material 6
7 Design 7
7.1 Attracting the catheter lumen 7
7.2 Attracting the catheter tip 7
7.3 Suction conduit connector 8
7.4 Closed suction catheters Additional requirements 9
7.4.1 Universal Design 9
7.4.2 Closed suction catheter patient end adapters and fittings 10
7.4.3 Protective cover 10
7.4.4 Vacuum control device for closed suction catheters 10
7.4.5 Flushing system for closed suction catheters 10
7.4.6 T-type cap 10
8 Performance requirements 11
8.1 Connection Fastness 11
8.2 Tube Performance 11
8.3 Vacuum control device performance 11
8.4 Leak 11
8.5 air resistance 12
8.6 Radiopacity 12
9 Requirements for suction catheters provided in sterile form 12
9.1 Sterility 12
9.2 Sterile supply of suction catheters 12
10 mark 12
10.1 Marking of the suction catheter 12
10.2 Use of symbols 14
10.3 Individually packaged labels 14
10.4 Labels for shelf/multi-unit packaging 14
Appendix A (informative) Basic Principles 15
Appendix B (Normative) Test Method for Connection Fastness 18
Appendix C (Normative Appendix) Residual Vacuum Test Method 19
Appendix D (Normative Appendix) Test Method for Leaks 20
Appendix E (informative) Hazard Identification for Risk Assessment 21
Reference 23
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0339-2009 "Attraction catheter for respiratory tract", compared with YY 0339-2009, except for editorial changes
The technical changes are as follows.
--- Increased requirements for closed suction catheters (see 7.4);
--- Revised the requirements for the treatment of ventilators (see 8.4 and 8.5);
--- Revised the requirements for risk management (see 4.1);
--- According to ISO 8836, the position description of 1, 2 in Figure C.1 is corrected (see Figure C.1, Figure B.1 in YY 0339-2009).
This standard uses the redrafting method to modify the international standard ISO 8836.2014 "Attraction catheter for respiratory tract" (English version).
The main technical differences between this standard and ISO 8836.2014 are as follows.
---About the normative reference documents, this standard has been technically adjusted to adapt to China's technical conditions, adjustments
The situation is reflected in Chapter 2, “Regulatory Citations”, and the specific adjustments are as follows.
● Replace the international standard ISO 594-1 with the national standard GB/T 1962.1 (see 7.4.5);
● Replace the international standard ISO 594-2 with the national standard GB/T 1962.2 (see 7.4.5);
● Replace the international standard ISO 4135.2001 with the national standard GB/T 4999 (see Chapter 3);
● Replace the international standard IEC 60601-1.2005 with the national standard GB 9706.1 (see 10.2);
● Replace the international standard ISO 7000 with the national standard GB/T 16273.1 (see 10.2);
● Replace the international standard ISO 10993-1 with the national standard GB/T 16886.1 (see 6.1);
● Replace the international standard ISO 11607-1 with the national standard GB/T 19633.1 (see 9.2.2);
● Replace the international standard ISO 11607-2 with the national standard GB/T 19633.2 (see 9.2.2);
● Replace the international standard ISO 14971.2007 with the industry standard YY/T 0316 (see 4.1.1);
● Replace the international standard ISO 15223-1 with the industry standard YY/T 0466.1 (see 10.2);
● Replace the international standard ISO 15223-2 with the industry standard YY/T 0466.2 (see 10.2);
● Replace the international standard ISO 10079-1 with the industry standard YY 0636.1 (see 7.3.1 and 7.3.6);
● Replace the international standard ISO 10079-2 with the industry standard YY 0636.2 (see 7.3.1 and 7.3.6);
● Replace the international standard ISO 10079-3 with the industry standard YY 0636.3 (see 7.3.1 and 7.3.6);
• Replace the international standard ISO 5356-1 with the industry standard YY/T 1040.1 (see 7.3.5, 7.4.2.1 and 7.4.2.2).
Compared with ISO 8836.2014, this standard has the following editorial changes.
--- Move the description of the main differences between ISO 8836.2014 and the previous version to this preface;
--- Fixed an editorial bug in ISO 8836.2014.
● Articles 7.3.6, 7.3.7 and 7.3.8 are changed to 7.3.5, 7.3.6 and 7.3.7 respectively;
• Move the normatively referenced document ISO 4135.2001 from the reference to the Chapter 2 normative reference;
● Move the non-normatively referenced document IEC 62366-1 from Chapter 2 normative references to the reference and use
Should be replaced by the industry standard YY/T 1474.
--- Removed the normative references ISO 594-1 and ISO 594-2 in Chapter 2 of Appendix A to be ISO 80369-7
Alternative instructions.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Anesthesia and Respiratory Equipment (SAC/TC116).
This standard was drafted. Shanghai Medical Device Testing Institute, Jiangsu Medical Device Testing Institute, Guangzhou Weili Medical Devices Co., Ltd.
the company.
The main drafters of this standard. Fu Guoqing, Qin Li, Huang Kaigen, Zhu Yu, Chen Tao.
introduction
This standard specifies the size and requirements of the suction catheter for the respiratory tract. Also includes an open suction tube made of a flexible material and
Basic requirements and confirmation methods for the specifications of closed suction catheters.
In order to help medical personnel to better select the most suitable suction catheter for a specific patient in clinical application, it is proposed to attract the catheter outside the catheter.
Description of the shape and size. The size of the suction catheter is determined by the outer diameter of the suction catheter. The outer diameter of the suction catheter is important because
The diameter determines whether the suction catheter can be well matched when used in conjunction with an endotracheal tube or a tracheostomy tube.
See Appendix A for an explanation of the contents of the standard with an asterisk (*).
Respiratory catheter
1 Scope
This standard specifies the requirements for suction catheters made of flexible materials intended for the respiratory tract, including open and closed suction.
catheter.
This standard applies to suction catheters with a pointed tip (such as Coudé catheters) or suction catheters with suction collectors.
The suction catheter is not considered to be a special suction catheter.
This standard does not apply to suction catheters intended for use with flammable anesthetic gases or pharmaceutical, laser or electrosurgical devices.
Note. Guidance documents for upper airway laser surgery airway management can be found in ISO /T R11991 [6].
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 1962.1 syringes, needles and other medical devices 6% (Ruhr) conical joints - Part 1. General requirements
(GB/T 1962.1-2015, ISO 594-1.1986, IDT)
GB/T 1962.2 syringes, needles and other medical devices 6% (Ruhr) conical joints Part 2. Locking joints
(GB/T 1962.2-2001, ISO 594-2..1998, IDT)
GB/T 4999 Anesthesia breathing equipment terminology (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 equipment - Part 1. General symbols (GB/T 16273.1-2008, ISO 7000.2004,
NEQ)
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (GB/T 16886.1-
2011, ISO 10993-1..2009, IDT)
GB/T 19633.1 End-sterilized medical device packaging - 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 of terminally sterilized medical devices - Part 2. Requirements for confirmation of forming, sealing and assembly processes
(GB/T 19633.2-2015, ISO 11607-2.2006, IDT)
YY/T 0316 Medical Device Risk Management for Medical Devices (YY/T 0316-2016, ISO 14971.2007,
IDT)
YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements
(YY/T 0466.1-2016, ISO 15223-1.2007, IDT)
YY/T 0466.2 Medical devices for the labeling, marking and the provision of information for medical devices - Part 2. Development of symbols,
Selection and confirmation (YY/T 0466.2-2015, ISO 15223-2.2010, IDT)
YY 0636.1 Medical suction equipment - Part 1. Safety requirements for electric suction equipment (YY 0636.1-2008, ISO 10079-1.
1999, MOD)
YY 0636.2 Medical suction equipment Part 2. Manually driven suction equipment (YY 0636.2-2008, ISO 10079-2.1999,
IDT)
YY 0636.3 Medical suction equipment - Part 3. Suction equipment powered by negative pressure or pressure source (YY 0636.3-2008,
ISO 10079-3.1999, IDT)
Related standard:   YY/T 0506.8-2019  YY/T 0490-2017
Related PDF sample:   YY 0339-2009  YY/T 0506.4-2016
   
 
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