YY/T 0338-2023Tracheostomy tubes and adapters (English PDF)
气管切开插管和接头
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 20, 2023
Implementation date
July 1, 2024
Scope
YY/T 0338-2023 is the English-translated version of 气管切开插管和接头.
YY/T 0338-2023 is the Chinese standard "Tracheostomy tubes and adapters". Its scope clause reads: 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. Its clauses include normative reference documents; terms and definitions.
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Document preview — YY/T 0338-2023
National Standard of the People's Republic of China
- ICS
- 11.040.10
- Classification
- C46
- Replacing
- YY/T 0338.1-2002; YY/T 0338.2-2002
Issued by: National Medical Products Administration
Contents
- Preface
- Introduction
- 1 Scope
- 2 Normative reference documents
- 3 Terms and Definitions
- 4 General requirements for tracheostomy tubes and connectors
- 5 Materials
- 6 Design requirements for tracheostomy tubes and connectors
- 6.1 General design requirements
- 6.2 Specification markings and dimensions
- 6.3 Design
- 7 Requirements for sterile delivered tracheostomy tubes
- 7.1 Sterility assurance
- 7.2 Packaging of sterile tracheostomy tubes
- 8 Information provided by the manufacturer
- 8.1 General
- 8.2 Fixed wing markings
- 8.3 Inflation indicator/marking on the balloon
- 8.4 Marking of tracheostomy tube connector
- 8.5 Additional markings for device packaging
- 8.6 Marking of inner cannula device packaging
- 8.7 Tracheostomy tube insert/instructions
- Appendix A (informative) Basis
- Appendix B (informative) Hazard identification for risk assessment
- Appendix D (normative) Test methods for cuff protrusion
- Appendix E (Normative) Test method for determining cuff diameter
- Appendix F (normative) Test method for cuff kink resistance
- Appendix G (Informative) Materials and Design Guidelines
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 1962.1-2015Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement
- GB/T 4999-2003Anaesthetic and respiratory equipment Vocabulary
- YY/T 0987.1-2016Implants for Surgery - Magnetic Resonance Compatibility - Part 1: Safety Marking
- YY/T 0987.2-2016Magnetic resonance compatibility for surgical implant - Part 2: Test method for magnetostrictive displacement
- YY/T 1040.1-2015Anaesthetic and respiratory equipment—Conical connectors - Part 1: Cones and sockets
- YY/T 1844-2022Anaesthetic and respiratory equipment - General requirements for airways and related equipment
ISO 594 · ISO 4135.2001 · ISO 5356 · ISO 18190.2016
Similar standards
Editions of YY/T 0338
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0338-2023 | Tracheostomy tubes and adapters | current edition | Current |
| YY/T 0338.1-2002; YY/T 0338.2-2002 | Tracheostomy tubes and adapters | previous edition | In force until 2024-07-01 |
This page sells the current edition, YY/T 0338-2023. Earlier editions are listed for reference only.
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Related Standards
GB/T 1962.1-2015 — Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement
GB/T 4999-2003 — Anaesthetic and respiratory equipment Vocabulary
YY/T 0987.1-2016 — Implants for Surgery - Magnetic Resonance Compatibility - Part 1: Safety Marking
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YY/T 0338-2023
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