YY 0337.1-2002Tracheal tubes - Part 1: Commonly-used tubes and connectors (English PDF)

3.1 angle of bevel

acute angle between the plane of the bevel and the longitudinal axis of the tracheal tube […]

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 […]