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YY/T 0490-2017

Chinese Standard: 'YY/T 0490-2017'
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Detail Information of YY/T 0490-2017; YY/T0490-2017
Description (Translated English): Tracheobronchial tubes--Sizing and marking
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C46
Classification of International Standard: 11.040.10
Word Count Estimation: 10,178
Date of Issue: 2017-05-02
Date of Implementation: 2018-04-01
Older Standard (superseded by this standard): YY/T 0490-2004
Drafting Organization: Shanghai Medical Device Testing Institute
Administrative Organization: National Anesthetic and Respiratory Equipment Standardization Technical Committee (SAC/TC 116)
Regulation (derived from): China Food & Drug Administration Announcement 2017 No. 49
Proposing organization: China Food and Drug Administration
Issuing agency(ies): State Food and Drug Administration

YY/T 0490-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.10
C 46
YY/T 0490-2017/ISO 16628.2008
Replacing YY/T 0490-2004
Tracheobronchial tubes – Sizing and marking
气管支气管导管 规格和标记
(ISO 16628.2008, IDT)
ISSUED ON. MAY 2, 2017
IMPLEMENTED ON. APRIL 1, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 6
4 General requirements ... 6
5 Marking ... 8
Annex A (Normative) Outside diameter determination of the bronchial
segment ... 10
Annex B (Normative) Test methods for determining the effective inside
diameter ... 12
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard replaces YY/T 0490-2004.
Compared with YY/T 0490-2004, the major technical changes are as follows.
-- the auxiliaries “should” expressed in most clauses are changed into “shall”;
-- the determination requirements for “the nominal maximum bronchoscope
diameter” in the general requirements of Clause 3 of the 2004 edition, are changed
into the determination requirements for “the effective inside diameter” om the
general requirements of Clause 4;
-- the marking requirements for “the perimeter of the bronchial segment” in 4.2.1 c)
and 4.3 d) in the marking of Clause 4 of the 2004 edition are deleted, which are
changed into the marking requirements for “the outside diameter of the bronchial
segment” in 5.2.1 c) and 5.3 d);
-- Annex A “Outside diameter determination of the bronchial segment of
tracheobronchial tubes” to the 2004 edition is changed into “Outside diameter
determination of the bronchial segment”, and the determination object and
calculation method are changed.
This Standard equivalently adopts the international standard ISO 16628.2008,
Tracheobronchial tubes – Sizing and marking.
The Chinese documents in the normative references in this Standard, which are
corresponding to the international documents, are as follows.
GB/T 16273.1-2008, Graphical symbols for use on equipment – Part 1. Common
symbols (ISO 7000.2004, NEQ)
YY/T 0466.1-2009, Medical devices – Symbols to be used with medical device labels,
labelling and information to be supplied – Part 1. General requirements (ISO 15223-
1.2007, IDT)
Comparing this Standard and ISO 16628.2008, the following editorial changes are
made.
-- “this international standard” is changed into “this standard”;
-- the decimal point “.” is used to replace the symbols “,” for numbers;
-- the foreword of ISO 16628.2008 is deleted;
-- the undated references in the “Normative references” are updated to the latest
editions and the documents not referenced to are deleted;
-- the editorial error of ISO 16628.2008 is changed, from “4.2” into “5.2” in 5.1.1.
Attention is drawn to the possibility that some of the elements of this document may
be the subject of patent rights. The issuer of this document shall not be held
responsible for identifying any or all such patent rights.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee 116 on
Anaesthetic and Respiratory Equipment of Standardization Administration of China
(SAC/TC 116).
The drafting organizations of this Standard. Shanghai Testing and Inspection Institute
for Medical Devices.
The main drafters of this Standard. Xu Chang, Wang Wei.
The previous editions of the standard replaced by this Standard are as follows.
-- YY/T 0490-2004.
Introduction
Originally a Technical Specification, this document is being revised as an International
Standard corresponding to this Standard to provide requirements for size designation
and labelling of tracheobronchial tubes. Such requirements will have the benefit of
enabling clinicians to select the most appropriate device for their patient population
and to select accessories such as fiberoptic bronchoscopes based on the measured
internal diameter of the bronchial segment of the tracheobronchial tube.
This standard provides requirements for manufacturers in establishing a standard
method of size designation for tracheobronchial tubes and their parts. A
tracheobronchial tube is a double lumen tracheal tube that facilitates selective
ventilation to one or both lungs and allows isolation of one lung from the other. It is
designed for either right or left mainstem bronchus placement, and has both a tracheal
and bronchial cuff.
Tracheobronchial tubes – Sizing and marking
1 Scope
This Standard provides requirements for size designation and labelling of
tracheobronchial tubes, including colour coding of the bronchial cuff and its associated
pilot balloon.
Tracheobronchial tubes that include bronchus blockers are excluded from the scope
of this Standard.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition dated applies to this document. For
undated references, the latest edition of the referenced documents (including all
amendments) applies to this document.
ISO 7000, Graphical symbols for use......
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