YY 0337.1-2002 English PDF (YY0337.1-2002)

Delivery: 3 seconds. Download true-PDF + Invoice.
Get QUOTATION in 1-minute: Click YY 0337.1-2002
Historical versions: YY 0337.1-2002
Preview True-PDF (Reload/Scroll if blank)

YY 0337.1-2002: Tracheal tubes. Part 1: Commonly-used tubes and connectors
YY/T 0337.1-2002 (Renamed from YY 0337.1-2002)
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.10
C 45
YY 0337.1-2002
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.
Tracheal tubes - Part 1: Commonly-used tubes and
connectors
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.
Specialized tubes are excluded from the scope of this standard.
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.
GB/T 1962.1, Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 1: General requirement (GB/T 1962.1-2001,
ISO 594-1:1986, IDT)
GB/T 16866.1, Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process (GB/T 16886. 1-2000, ISO 10993-1: 1997,
IDT)
YY 91040, Anaesthetic and respiratory equipment. Conical connectors. Cones and
sockets
ISO 11607, Packaging for terminally sterilized medical devices - Part 1:
Requirements for materials, sterile barrier systems and packaging systems
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 angle of bevel
acute angle between the plane of the bevel and the longitudinal axis of the tracheal tube
f) marking of the size of tracheal tubes situated as shown in Figure 1 a) and b) and
Figure 4, as appropriate, on the side of the tube reading from the patient end to
the machine end. Plain tubes shall have the size marked in a region equivalent to
cuffed tubes of similar size.
7.2.1.2 Additional marks may be provided to assist in positioning the tracheal tube
within the trachea.
7.2.1.3 Marking materials shall be of a colour that contrasts with the colour of the tube.
7.2.2 Marking on the tracheal tube individual pack and any insert
7.2.2.1 The following shall be marked on, or visible through, the tracheal tube
individual pack and may additionally be given on an insert:
a) if the unit package of a cuffed tube is not transparent, the distance of the point of
separation of the inflating tube and tracheal tube from the patient end;
b) a description of contents;
c) the word "Oral", "Nasal" or "Oral/Nasal" as appropriate;
d) the designated size (nominal inside diameter) in accordance with 4.1;
NOTE: The figure denoting the inside diameter should be in larger and bolder type than that
denoting the outside diameter.
e) the outside diameter expressed in millimetres;
f) the name and/or trademark of the manufacturer and/or supplier;
g) the batch number;
NOTE: It is strongly recommended that the "use by" date be given.
h) the word "STERILE" if appropriate;
NOTE: It is recommended that the method of sterilization be given.
i) for tubes not intended for re-use, the words "single use" or equivalent;
j) if the straight portion of the tube extends beyond the machine end of the cuff (see
4.7.2), this shall be stated, for example by the words "straight patient end";
k) for cuffed tubes, the resting diameter of the cuff, determined in accordance with
annex A and expressed in millimetres to two significant figures.
7.2.2.2 Unless the tracheal tube is intended and marked as being for single use.
instructions for cleaning and disinfection or sterilization, and the maximum number or