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YY/T 0486-2024: Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
Status: Valid YY/T 0486: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0486-2024 | English | 239 |
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Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
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YY/T 0486-2024
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| YY/T 0486-2016 | English | 174 |
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Tracheal tubes designed for laser surgery--Requirements for marking and accompanying information
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YY/T 0486-2016
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| YY/T 0486-2004 | English | 319 |
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Tracheal tubes designed for laser surgery. Requirements for marking and accompanying information
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YY/T 0486-2004
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PDF similar to YY/T 0486-2024
Basic data | Standard ID | YY/T 0486-2024 (YY/T0486-2024) | | Description (Translated English) | Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Word Count Estimation | 11,125 | | Date of Issue | 2024-02-07 | | Date of Implementation | 2025-03-01 | | Older Standard (superseded by this standard) | YY/T 0486-2016 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies requirements for marking, labeling and information provided by manufacturers of cuffed and uncuffed endotracheal tubes and related materials designed to withstand laser ignition. | YY/T 0486-2024: Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.10
CCSC46
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 0486-2016
Tracheal tube for laser surgery
Requirements for marking and accompanying information
(ISO 14408.2016, MOD)
Released on 2024-02-07
2025-03-01 Implementation
The State Drug Administration issued
Table of Contents
Preface I
Introduction II
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Marking and labeling 2
4.1 Use of symbols 2
4.2 Mark 2
4.3 Labelling of packaging 2
4.4 Labelling of shelf-ready packaging or multi-unit packaging 3
5 Information provided by the manufacturer 3
5.1 Instructions for the preparation and use of laser-resistant endotracheal tubes and endotracheal tube handling 3
5.2 Instructions for use 4
5.3 Warnings and precautions for use with catheters 4
5.4 Laser resistance test results shown in Figure 4
References 6
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document replaces the revision of YY/T 0486-2016 "Requirements for marking and random information of endotracheal tubes for laser surgery"
Compared with YY/T 0486-2016, in addition to editorial changes, the main technical changes are as follows.
--- Changed the normative reference documents;
--- Added the selection of label symbols (see Chapter 4, 4.3, 4.4).
This document is modified to adopt the international standard ISO 14408.2016 "Requirements for marking and accompanying information of endotracheal tubes for laser surgery".
The technical differences between this document and ISO 14408.2016 and their reasons are as follows.
--- ISO 11990-1 and ISO 11990-2 (see 5.3 and 5.4) are replaced by the normative reference ISO 11990 to adapt to my country
National conditions.
Compared with ISO 14408.2016, this document has made the following editorial changes.
--- Changed the standard name of ISO 5361;
---ISO 20417 replaced EN1041.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Anesthesia and Respiratory Equipment (SAC/TC116).
This document was drafted by. Shanghai Institute of Medical Device Inspection and Medtronic (Shanghai) Management Co., Ltd.
The main drafters of this document are Yang Xiaoqing, Xu Chang, Wang Wei, Mo Yanjun and Qian Xinyi.
The previous versions of the documents replaced by this document are as follows.
---First published in.2004 as YY/T 0486-2004, first revised in.2016;
---This is the second revision.
Introduction
The purpose of this document is to specify the characteristics of endotracheal tubes that are designed to resist ignition by lasers and have been tested for laser resistance in accordance with ISO 11990.
Requirements for identification, labelling and the information to be provided, including a standard format for reporting results obtained when tests are carried out in accordance with ISO 11990.
By limiting the requirements to disclosure of information determined according to the ISO 11990 test methods, manufacturers can
Maximize the selection.
Tracheal tube for laser surgery
Requirements for marking and accompanying information
1 Scope
This document specifies the marking, labeling, and manufacturing of cuffed and uncuffed endotracheal tubes and related materials designed to resist laser ignition.
Requests for information from suppliers.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
YY/T 0466.1-2016 Medical devices Symbols for labeling, marking and providing information on medical devices Part 1.General requirements
Request (ISO 15223-1.2012, IDT)
isteredsymbols)
ISO 11990 Lasers and laser-related equipment - Determination of laser resistance of endotracheal tubes and endotracheal tube cuffs
cuffs
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
tracheal tube
A tube designed to be inserted through the larynx into the trachea and to deliver gases and steam through the trachea.
[Source. GB/T 4999-2003, 6.3.1]
3.2
Cuff
A permanently attached, inflatable balloon at the patient-adjacent end of an endotracheal tube that provides an effective seal between the tube and the trachea.
[Source. GB/T 4999-2003, 6.3.6, modified]
3.3
Manufacturers design endotracheal tubes specifically for use in airway laser surgery.
Note. This includes devices that are preassembled or sold in kit form.
3.4
A covering and/or surface treatment that renders a laser-intolerant endotracheal tube suitable for airway laser surgery.
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