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YY/T 0338-2023: Tracheostomy tubes and connectors
Status: Valid YY/T 0338: Evolution and historical versions
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| YY/T 0338-2023 | English | 539 |
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Tracheostomy tubes and connectors
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YY/T 0338-2023
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| YY 0338.1-2002 | English | 559 |
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Tracheotomy tubes. Part 1: Tubes and connectors for adults
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PDF similar to YY/T 0338-2023
Basic data | Standard ID | YY/T 0338-2023 (YY/T0338-2023) | | Description (Translated English) | Tracheostomy tubes and connectors | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Word Count Estimation | 26,259 | | Date of Issue | 2023-06-20 | | Date of Implementation | 2024-07-01 | | Older Standard (superseded by this standard) | YY/T 0338.1-2002; YY/T 0338.2-2002 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements for adult and pediatric tracheostomy tubes and connectors. This standard applies to intubation designed primarily for patients requiring anesthesia, artificial ventilation, or other assisted breathing. This standard applies to specialized tracheostomy tubes with common characteristics, such as those suitable for spontaneously breathing patients without a connector at the machine end, and tubes or straps that have reinforced walls or are made of metal. Shoulder cannula, tapered cannula, cannula with aspiration or monitoring or delivery of drugs or other gases. | YY/T 0338-2023: Tracheostomy tubes and connectors---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.10
CCSC46
Pharmaceutical Industry Standards of the People's Republic of China
Replace YY/T 0338.1-2002, YY/T 0338.2-2002
Tracheotomy tubes and connectors
Published on 2023-06-20
2024-07-01 Implementation
Released by the State Drug Administration
Table of contents
PrefaceⅠ
Introduction V
1 Scope 1
2 Normative reference documents 1
3 Terms and Definitions 1
4 General requirements for tracheostomy tubes and connectors4
5 Materials 4
6 Design requirements for tracheostomy tubes and connectors 4
6.1 General design requirements 4
6.2 Specification markings and dimensions 4
6.3 Design 5
7 Requirements for sterile delivered tracheostomy tubes7
7.1 Sterility assurance7
7.2 Packaging of sterile tracheostomy tubes7
8 Information provided by the manufacturer8
8.1 General 8
8.2 Fixed wing markings 8
8.3 Inflation indicator/marking on the balloon 8
8.4 Marking of tracheostomy tube connector 8
8.5 Additional markings for device packaging8
8.6 Marking of inner cannula device packaging9
8.7 Tracheostomy tube insert/instructions9
Appendix A (informative) Basis 10
Appendix B (informative) Hazard identification for risk assessment12
Appendix C (normative) Test method for the firmness of the connection between the matching connector and the fixed wing and the tracheostomy tube 14
Appendix D (normative) Test methods for cuff protrusion15
Appendix E (Normative) Test method for determining cuff diameter 17
Appendix F (normative) Test method for cuff kink resistance18
Appendix G (Informative) Materials and Design Guidelines 19
Reference 20
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
This document replaces YY/T 0338.1-2002 "Tracheostomy Intubation Part 1.Intubation and Connectors for Adults" and
YY/T 0338.2-2002 "Tracheostomy Intubation Part 1.Tracheostomy Intubation in Pediatrics", which is the same as YY/T 0338.1-2002 and
Compared with YY/T 0338.2-2002, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
a) Changed the scope and added special tracheostomy tubes applicable to common characteristics (see Chapter 1, YY/T 0338.1-
2002 and Chapter 1 of YY/T 0338.2-2002);
b) Delete the definitions of pediatric tracheostomy intubation and pediatric tracheostomy intubation connectors (see YY/T 0338.2-2002
3.1, 3.2);
c) Added that manufacturers should evaluate the inner diameter of 15mm connectors and YY/T 0916 series small-bore connectors during the risk management process
Requirements for the risk of incorrect connections (see 6.3.1.4);
d) Added the requirement that the locking mechanism of the adjustable fixed wings should not cause the internal dimensions of the tracheostomy tube to be reduced by more than 10%
(See 6.3.2.3);
e) Added that when the tracheostomy tube is in situ, it should be possible to visually determine whether the internal tube is present without disconnecting the respiratory system.
requirements (see 6.3.3.3);
f) Added requirements related to the design and appearance of the cuff (see 6.3.4);
g) Added the requirement that the patient end should have no sharp edges (see 6.3.8.2);
h) Added the requirement that it should not be possible to connect the machine end to the respiratory system unless the intubation core has been removed (see 6.3.9.3);
i) Added design and appearance requirements for radiopaque markings (see 6.3.10);
j) Added kink-resistant design and appearance requirements (see 6.3.11);
k) Added requirements for markings on inflation indicators/indicating balloons (see 8.3);
l) Added requirements for inserts/instructions for tracheostomy tubes (see 8.7);
m) The test method for the firmness of the connection between the mating joint and the fixed wing and the tracheostomy tube in Appendix C has been changed (see Appendix C,
Appendix A of YY/T 0338.1-2002 and YY/T 0338.2-2002);
n) Added the test method for cuff protrusion in Appendix D (see Appendix D);
o) Added Appendix F test method for cuff kink resistance (see Appendix F).
This document has been modified to adopt ISO 5366.2016 "Tracheostomy Tubes and Connectors for Anesthesia and Respiratory Equipment".
Compared with ISO 5366.2016, this document has made the following structural adjustments.
---Appendix B corresponds to Appendix G in ISO 5366.2016;
---Appendix C corresponds to Appendix B in ISO 5366.2016;
---Appendix E corresponds to Appendix C in ISO 5366.2016;
---Appendix F corresponds to Appendix E in ISO 5366.2016;
---Appendix G corresponds to Appendix F in ISO 5366.2016.
The technical differences between this document and ISO 5366.2016 and their reasons are as follows.
a) Change "6.3.7.1 The free end of the inflation tube shall mate with a male conical joint conforming to ISO 80369-7" to "The free end of the inflation tube
The end should be matched with an external conical joint that complies with GB/T 1962.1-2015.” This is because ISO 80369-7 has not yet been converted into a domestic standard.
Therefore, the currently valid domestic GB/T 1962.1-2015 is adopted;
b) The redundant part after item b) in 8.7 has been deleted. This is an errata.
The following editorial changes have been made to this document.
---To avoid ambiguity, change "θ=105°" in the indexing number description of Figure E.1 in ISO 5366.2016 to "Example. θ=
105°", because "θ=105°" here is only an example, not a fixed value.
Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents.
This document is proposed by the National Medical Products Administration.
This document is under the jurisdiction of Shandong Medical Device and Drug Packaging Inspection Institute.
This document was drafted by. Shandong Medical Device and Drug Packaging Inspection Institute, Medtronic (Shanghai) Management Co., Ltd., Henan Tuoren
Medical Equipment Group Co., Ltd., Henan Yadu Industrial Co., Ltd., Guangzhou Weili Medical Equipment Co., Ltd., Teleflex Medical Equipment Co., Ltd.
Trade (Shanghai) Co., Ltd.
The main drafters of this document. Ai Chongchong, Wang Xiuxiu, Mo Yanjun, Gao Yupeng, Duan Shuxia, Liu Jing, Li Kanyuan, Liu Xin, Yang Jing, Liu Xiangdong.
The previous versions of this document and the documents it replaces are as follows.
---YY/T 0338.1, first released in.2002;
---YY/T 0338.2, first released in.2002.
Introduction
This document provides basic requirements for the design of cuffed and uncuffed tracheostomy tubes and connectors. These instruments are inserted through the tracheostomy
Inlet, used to transport gas and steam in and out of the trachea. Cuffed devices are designed to seal and prevent tracheal aspiration and provide
The room provides an unobstructed airway for spontaneously breathing, assisted breathing, or controlled breathing patients. Due to the wide variety of specialized tracheostomy tubes now widely
applications and comply with similar basic requirements stipulated in this document. Therefore, this document includes special intubation tubes whose tube walls are reinforced with metal or nylon,
There are shoulder cannulas, tapered tubes, tubes provided for suctioning or monitoring or delivering drugs or other gases, and many other types of specialized tracheostomies.
Open intubation.
Methods for describing cannula size and configuration have been designed to assist clinicians in selecting the cannula that best fits a specific patient's configuration. Dimensions within
The internal dimensions are marked because this dimension is crucial in relation to airflow resistance. Since stoma and tracheal size are also important in selecting tracheostomy intubation
factors, so it is necessary for users to fully understand the external dimensions of each specification of cannula.
Cuffed tracheostomy tubes can be characterized by the internal and external dimensions of the tube and the cuff inflation diameter.
A variety of cuff designs are available to meet special clinical needs. This document includes requirements for tracheostomy intubation in children and adults. two
There are many common requirements that can be standardized and are important to patient safety. Because infants or children are different from adults in size,
There are differences in airway structure and respiratory physiology, so airway equipment for pediatric patients and adult patients differs in size and basic design.
There are differences in all aspects. This document does not provide for the fitting to be permanently attached to the tube as this would be impractical for infants and young children. This document stipulates
There are other acceptable methods that can be used to connect these components. This document does not limit the scope of intubation design, which needs to be consistent with the pediatric physiological structure
Changes, lesions and spatial constraints encountered are matched.
Tracheotomy tubes and connectors
1 Scope
This document specifies the requirements for tracheostomy tubes and connectors for adult and pediatric use.
This document applies to intubations designed primarily for patients requiring anesthesia, artificial ventilation, or other assisted breathing.
This document applies to specialized tracheostomy tubes with common characteristics, such as those without connectors at the machine end and suitable for spontaneous breathing.
Tracheostomy tubes for patients, as well as tubes with reinforced walls or made of metal or with shoulders, tapered tubes, and tubes with a
A cannula for suctioning or monitoring or delivering drugs or other gases.
NOTE. The flammability of tracheostomy tubes (e.g. electrosurgical instruments or lasers used with flammable anesthetics in oxygen-rich air) is a well-known hazard and is a
In the scope of clinical management, it is not included in the scope of this document. ISO /T R11991 gives guidance on avoiding airway burning.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document.
GB/T 1962.1-2015 Syringes, injection needles and other medical devices 6% (Luer) conical connectors Part 1.General requirements
(ISO 594-1.1986,IDT)
GB/T 4999-2003 Anesthesia and respiratory equipment terminology (ISO 4135.2001, IDT)
YY/T 0987.1-2016 Magnetic resonance compatibility of surgical implants Part 1.Safety markings
YY/T 0987.2-2016 Magnetic resonance compatibility of surgical implants Part 2.Magnetic displacement force test method
YY/T 1040.1-2015 Conical connectors for anesthesia and respiratory equipment Part 1.Conical heads and sleeves (ISO 5356-1.
2004,IDT)
Note. YY/T 1844-2022 General requirements for airways and related equipment for anesthesia and respiratory equipment (ISO 18190.2016, MOD)
3 Terms and definitions
The terms and definitions defined in GB/T 4999-2003 and the following apply to this document.
NOTE. A diagram of a typical tracheostomy tube and related terminology is shown in Figure 1.
3.1
angleofbevel
The angle between the plane of the bevel (3.2) and the longitudinal axis of the tracheostomy tube (3.13).
3.2
Bevel
The angled portion of the patient end (3.12) of the tracheostomy tube (3.13).
3.3
cuff
An inflatable balloon located near the patient end of a tracheostomy tube to form a seal between the tube and trachea.
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