YY 0337.1-2002 PDF English
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Tracheal tubes. Part 1: Commonly-used tubes and connectors
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YY 0337.1-2002: Tracheal tubes. Part 1: Commonly-used tubes and connectors---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0337.1-2002
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.10
C 45
Tracheal tubes - Part 1.Commonly-used tubes and
connectors
(ISO 5361.1999 Anaesthetic and respiratory equipment - Tracheal tubes and
connectors, IDT)
Issued on. SEPTEMBER 24, 2002
Implemented on. APRIL 01, 2003
Issued by. National Medical Products Administration
According to the Announcement of the Medical Device Industry Standards of National
Medical Products Administration (No. 76, 2022), this standard will be converted into a
recommendatory standard from September 7, 2022.It will no longer be mandatory.
Table of Contents
Foreword... 3
Introduction... 4
1 Scope... 6
2 Normative references... 6
3 Terms and definitions... 6
4 General requirements for tracheal tubes and tracheal tube connectors... 8
5 Additional requirements for tracheal tubes with a Murphy eye... 17
6 Requirements for tracheal tubes with tracheal tube connector supplied sterile... 17
7 Marking... 18
Annex A (normative) Determination of cuff resting diameter... 21
Annex B (normative) Test method for tube collapse... 22
Annex C (normative) Test method for cuff herniation... 25
Annex D (informative) Guidance on materials and design... 27
Bibliography... 29
Foreword
This Part of YY 0337 identically uses ISO 5361.1999 "Anaesthetic and respiratory
equipment - Tracheal tubes and connectors".
The general title of YY 0337 is "Tracheal tubes". It consists of the following parts.
Part 1.Commonly-used tubes and connectors
Part 2.Part 2.Cole type tube
Annex A, Annex B and Annex C of this Part are normative. Annex D is informative.
This Part was proposed by National Medical Products Administration.
This Part shall be under the jurisdiction of Jinan Medical Device Quality Supervision
and Inspection Center of National Medical Products Administration.
Main drafting organizations of this Part. Jinan Medical Device Quality Supervision and
Inspection Center of National Medical Products Administration.
The drafting organizations of this Part. Guangzhou Panyu Weili Medical Products Co.,
Ltd., Zhejiang Jiaxing Sujia Medical Instrument Factory, and Hangzhou Jingling
Medical Instrument Co., Ltd.
Main drafters of this Part. Wu Ping, Xin Rendong, Tian Qing, Song Jinzi, Zhang Liqing.
1 Scope
This Part of YY 0337 specifies requirements for the dimensions, basic properties and
method of size designation of the most commonly used types of oral-tracheal and naso-
tracheal tube made of plastics materials and/or rubber (plain and cuffed), and
requirements for tracheal tube connectors.
2 Normative references
The provisions in following documents become the provisions of this Part of YY 0337
through reference in this Part. For dated references, the subsequent amendments
(excluding corrigendum) or revisions do not apply to this Part, however, parties who
reach an agreement based on this Part are encouraged to study if the latest versions of
these documents are applicable. For undated references, the latest edition of the
referenced document applies.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
tracheal tube for insertion through the nose into the trachea
balloon fitted to the inflating tube to indicate inflation of the cuff
4 General requirements for tracheal tubes and tracheal tube connectors
The inflating tube, if provided, shall have an outside diameter of not more than
3.0 mm and the point of separation shall be situated on the concave aspect of the tracheal
tube. The wall around the inflation lumen shall not encroach on the lumen of the
tracheal tube by more than 10% of the inside diameter of the tracheal tube. The
dimensions of the inflating tube shall be in accordance with Table 1 and Figure 1 a) and
b).
5 Additional requirements for tracheal tubes with a Murphy eye
The location of the eye shall be on the side of the tube opposite the bevel.
6 Requirements for tracheal tubes with tracheal tube connector supplied sterile
Each tracheal tube with tracheal tube connector supplied and marked as "STERILE"
shall be contained in an individual pack. The pack shall serve as an effective barrier to
the penetration of microorganisms and particulate material, in accordance with ISO
11607.
7 Marking
The tracheal tube connector shall be clearly marked with the designated size (nominal
inside diameter) in accordance with 4.1.
Annex A
(normative)
Determination of cuff resting diameter
The resting diameter of the cuff is measured when the cuff is inflated with a pressure
which is intended to remove creases but minimize stretching of its walls.
Annex B
(normative)
Test method for tube collapse
The resistance to tube collapses due to inward cuff pressure is tested by passing a steel
ball through the tracheal tube lumen with the cuff inflated within a transparent tube.
Annex C
(normative)
Test method for cuff herniation
The tendency of the cuff to herniate beyond the plane perpendicular to the long axis of
the tube at the nearest edge of the bevel is tested by applying an axial force with the
cuff inflated within a transparent tube.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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