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YY/T 0490-2017

Chinese Standard: 'YY/T 0490-2017'
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BASIC DATA
Standard ID YY/T 0490-2017 (YY/T0490-2017)
Description (Translated English) Tracheobronchial tubes--Sizing and marking
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 10,159
Date of Issue 2017-05-02
Date of Implementation 2018-04-01
Older Standard (superseded by this standard) YY/T 0490-2004
Drafting Organization Shanghai Medical Device Testing Institute
Administrative Organization National Anesthetic and Respiratory Equipment Standardization Technical Committee (SAC/TC 116)
Regulation (derived from) China Food & Drug Administration Announcement 2017 No. 49
Proposing organization China Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration

YY/T 0490-2017
Tracheobronchial tubes-Sizing and marking
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0490-2004
Tracheobronchial catheter specifications and marking
(ISO 16628.2008, IDT)
Published by.2017-05-02
2018-04-01 implementation
State Food and Drug Administration issued
Content
Foreword I
Introduction II
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 General requirements 1
5 mark 2
Appendix A (Normative) Determination of the outer diameter of the bronchial segment 4
Appendix B (Normative Appendix) Method for Measuring Effective Inner Diameter 5
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0490-2004.
Compared with YY/T 0490-2004, the main technical changes of this standard are as follows.
--- The auxiliary verbs expressed in most of the articles were changed from "宜" to "should";
--- The.2004 version of the general requirements of the general requirements of the "nominal maximum bronchoscope diameter" was deleted, changed to Chapter 4
The requirements for the determination of the "effective inner diameter" in the requirements;
--- The marking requirements for the "bronchial segment circumference" in 4.2.1c) and 4.3d) of Chapter 4 of the.2004 edition were deleted and changed to Chapter 5.
Marking requirements for "outer bronchial segment outer diameter" in 5.2.1c) and 5.3d);
--- Appendix A was changed from the.2004 edition of "Measurement of the circumference of the bronchial segment of the tracheobronchial intubation" to the measurement of the outer diameter of the bronchial segment
"," the measurement object and the calculation method change;
This standard is equivalent to the international standard ISO 16628.2008 "tracheal bronchial catheter --- specifications and markings."
The documents of our country that have a consistent correspondence with the international documents referenced in this standard are as follows.
GB/T 16273.1-2008 Graphical symbols for equipment - Part 1. General symbols (ISO 7000.2004, NEQ)
YY/T 0466.1-2009 Medical devices for the labeling, marking and information of medical devices - Part 1. General
Seeking (ISO 15223-1.2007, IDT)
Compared with ISO 16628.2008, this standard makes the following editorial changes.
--- "This International Standard" is replaced by the word "this standard";
---Involving numbers with the decimal symbol "." instead of the symbol ",";
--- Removed the preface to ISO 16628.2008;
---Update the undated references in the "normative references" to the latest version and delete the files not referenced in the body;
--- Modified the editorial error in ISO 16628.2008, and changed "4.2" in 5.1.1 to "5.2".
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 Food and 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.
The main drafters of this standard. Xu Chang, Wang Wei.
The previous versions of the standards replaced by this standard.
---YY/T 0490-2004.
introduction
The international document corresponding to this standard was originally a technical specification and has now been revised to a standard for the specification of tracheobronchial catheters.
Regulations and labeling requirements. These requirements will benefit the clinician in selecting the most appropriate device for the patient and based on the measured tracheal qi
The bronchial segment inner diameter of the catheter is selected as an accessory, such as a fiberoptic bronchoscope.
To establish a standard method for the design of a tracheal bronchial catheter and its component specifications, this standard specifies the requirements for the manufacturer. Tracheal branch
The endotracheal tube is a dual-lumen endotracheal tube that selectively ventilates one or both sides of the lung and allows ventilation of one side of the lung to the other
Separated. It is designed to insert the right main bronchus or the left main bronchus and has a tracheal cuff and a bronchial cuff.
Tracheobronchial catheter specifications and marking
1 Scope
This standard specifies the specification and labeling requirements for tracheobronchial ducts, including the color markers of the bronchial cuff and its indicator balloon.
The requirements of knowledge.
This standard does not apply to tracheobronchial ducts with bronchial obstruction.
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.
Graphical symbol registration symbol for ISO 7000 devices (Graphicalsymbolsforuseonequipment- Registered
Symbols)
ISO 15223-1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements
(Medicaldevices-Symbolstobeusedwithmedicaldevicelabels,labelingandinformationtobesup-
plied-Part 1.Generalrequirements)
EN1041 Information on medical devices provided by the manufacturer (Informationsuppliedbythemanufacturerwith
Medicaldevices)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Tracheobronchial tube tracheobronchialtube
Designed to insert a trachea and a main bronchus to separate the dual lumen catheters of the left and right lungs.
4 General requirements
4.1 bronchial segment outer diameter
The outer diameter of the bronchial segment of the catheter should be the outer diameter measured at the midpoint of the bronchial cuff after deflation (see Note 9 in Figure 1), in millimeters.
Bit, as determined in Appendix A.
4.2 Effective inner diameter
The inner diameter of the bronchial and tracheal lumens shall be determined in accordance with Appendix B, in millimeters.
Note. The effective internal diameter helps to select a bronchoscope or other instrument of appropriate diameter for insertion into the tracheal bronchial catheter.
4.3 Color identification
The bronchial cuff and its indicator balloon should be blue overall.
Section 4.4
When viewed from the machine side, the tracheal and bronchial segments should be clearly distinguished.
Description.
1---the end of the tracheobronchial catheter;
2---bronchial segment;
3---tracheal cavity section (not necessarily round);
4---bronchial lumen section (not necessarily circular);
5---the patient end of the bronchial segment;
6---the patient end of the tracheal section;
7---tracheal cuff;
8---bronchial cuff;
9---Measurement point of the outer diameter of the bronchial segment.
Figure 1 Example of a tracheobronchial catheter
5 mark
5.1 Use of symbols
5.1.1 Suitable symbols in ISO 7000 or ISO 15223-1 are available to meet the requirements of 5.2.
5.1.2 The marking, packaging, inserts, and information provided by the manufacturer of the tracheobronchial catheter shall be in accordance with EN1041.
5.2 Marking of tracheobronchial ducts
5.2.1 The tracheobronchial duct should contain the following markings.
a) the name and/or trademark of the manufacturer or supplier;
b) manufacturing specifications for the trademark (eg 39Fr.);
c) The outer diameter of the bronchial segment in accordance with 4.1, in millimeters, prefixed with “Br”, as shown in the following example.
Example. Br13.0OD;
d) for single-use tracheobronchial tubes, "single use" or equivalent;
e) the length of the 2 cm interval mark, the distance from the tip of the patient end of the bronchial segment, marked on the machine end of the tracheal segment;
f) “Right” or “Left” or equivalent, if applicable.
5.2.2 The color of the marking should be in sharp contrast to the color of the cannula.
5.3 Single package of tracheobronchial catheter and marking on any insert
The single package of the tracheobronchial tube should be marked, or the following mark should be visible through a single package. The insert can also be given separately.
a) a description of the contents;
b) “Right” or “Left” or equivalent mark, if applicable;
c) Manufacturer's nominal specifications (eg 39Fr.)
d) The outer diameter of the bronchial segment in accordance with 4.1, expressed in millimeters, prefixed with "Br", see example below.
Example. Br13.0OD
e) an effective inner diameter in accordance with 4.2;
f) the name and/or trademark of the manufacturer;
g) batch number (highly recommended for the expiration date);
h) “Septic” or equivalent mark (recommended for sterilization), if applicable;
i) “single use” or equivalent mark for catheters intended for non-repetitive use;
j) If the device contains natural rubber (latex), label it;
k) instructions for cleaning, disinfecting or sterilizing catheters that are not marked as single use;
l) If a non-sterile catheter is supplied, the appropriate sterilization method is recommended.
Appendix A
(normative appendix)
Determination of the outer diameter of the bronchial segment
A.1 Principle
The catheter bronchial segment is measured by winding an inelastic wire on the bronchial segment of the tracheobronchial tube and measuring the length of the wire.
Outer diameter (OD). This method measures the equivalent circle diameter (see A.3.3).
A.2 Instrument
A.2.1 Inelastic filaments of sufficient length to be entangled five times at the midpoint of the bronchial cuff (see Figure 9 of Figure 1) after deflation of the bronchial segment.
A.2.2 Apparatus for measuring the length of inelastic threads (A.2.1) in millimeters.
A.3 steps
A.3.1 On the bronchial segment of the catheter, use the inelastic silk thread (A.2.1) to surround the midpoint of the bronchial cuff after deflation (see Note 9 in Figure 1).
Wrap five turns around the gap.
A.3.2 Measure the length of the inelastic wire in millimeters.
A.3.3 The outer diameter (OD) is calculated by dividing the length of the wire by 5π (ie. 5 × 3.14 = 15.7).
A.4 result representation
The results measured in accordance with A.3.3 are expressed in millimeters, retained to one decimal place, and uploaded to the nearest 0.5 mm.
Example. 9.1mm is expressed as 9.5mm
9.6mm is expressed as 10.0mm
13.1mm is expressed as 13.5mm
Note. The diameter is expressed as a larger 0.5 mm to ensure that a catheter that is thinner than the bronchus is selected.
Appendix B
(normative appendix)
Effective inner diameter measurement method
B.1 Principle
The effective inner diameter (ID) was determined by passing a series of measuring beads through the bronchial segments of the catheter and the lumen of the tracheal segment. Measuring the diameter of the bead
The table can pass through the largest diameter of the bronchoscope of the tracheal and bronchial lumen of the tracheobronchial duct. This trial was performed because the bronchoscope was
Flexibility is limited when passing through a curved lumen, and the cross-section of the lumen of the catheter may be non-circular to limit measurement (see Figure 1).
B.2 Instruments
B.2.1 Three polished cylindrical measuring beads (see Figure B.1) with the same diameter D and a spherical end with a total length of twice the diameter (2D). diameter
The accuracy should be ±0.01mm and the length accuracy should be ±0.1mm. The end radius should be the nominal radius, and the knot length between each measuring bead should be
It is 1mm~2mm. To determine the maximum bronchoscope diameter, multiple sets of measuring beads should be used with a diameter of 0.2 mm. If the manufacturer
The maximum bronchoscope diameter is given and can be verified using a set of measu......
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