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www.ChineseStandard.net Database: 189760 (18 Oct 2025)

YY 0499-2023 English PDF

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YY 0499-2023: Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation
Status: Valid

YY 0499: Evolution and historical versions

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY 0499-2023	English	379	Add to Cart	4 days [Need to translate]	Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation	Valid	YY 0499-2023
YY 0499-2004	English	229	Add to Cart	3 days [Need to translate]	General specifications for anaesthetic laryngoscope	Valid	YY 0499-2004

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Basic data

Standard ID	YY 0499-2023 (YY0499-2023)
Description (Translated English)	Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation
Sector / Industry	Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard	C46
Classification of International Standard	11.040.10
Word Count Estimation	20,251
Date of Issue	2023-03-14
Date of Implementation	2026-05-01
Older Standard (superseded by this standard)	YY 0499-2004, YY 91123-1999, YY 91136-1999, YY 0498.1-2004, YY 0498.2-2004
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the requirements for laryngoscopes with non-flexible blades and the critical dimensions of handles and laryngoscope blades with interchangeable hook-on connections. This document applies to laryngoscopes with an internal battery-powered power supply for illuminating the larynx during intubation. This document does not apply to the following products: flexible laryngoscopes, laryngoscopes designed for surgery, mains powered laryngoscopes, laryngoscopes connected to an external light source via fiber optic cable, designed for connection to external, integral or add-on video systems Working video laryngoscope.

YY 0499-2023: Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation

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ICS11:040:10 CCSC46 Pharmaceutical Industry Standard of the People's Republic of China Replacing YY 0499-2004, YY 91123-1999, YY 91136-1999, YY 0498:1-2004, YY 0498:2-2004 Anesthesia and Respiratory Equipment Laryngoscopes for Endotracheal Intubation (ISO 7376:2020, MOD) Released on 2023-03-14 2026-05-01 Implementation Released by the State Drug Administration

Preface I Introduction II 1 * Range 1 2 Normative references 1 3 *Terms and Definitions1 4 General requirements 2 5 material 2 6 Design requirements 2 6:1 General requirements 2 6:2 * Environmental conditions 2 7 Performance requirements 2 7:1 Handle 2 7:1:1 * Electrical Safety 2 7:1:2 Electrical contacts 3 7:1:3 Size 3 7:1:4 * Light output 4 7:1:5 *Strength 4 7:2 Laryngoscope blade 4 7:2:1 Size 4 7:2:2 * Stiffness 5 7:2:3 *Strength 5 7:2:4 * Lighting 5 7:2:5 Electrical interface 5 7:3 Hinge combination 5 7:4 One-piece laryngoscope6 8 Cleaning, Disinfection and Sterilization7 9 Information provided by the manufacturer7 9:1 General requirements 7 9:2 Marking 7 9:3 Size codes for different target patient populations7 9:4 User Manual 7 Appendix A (Informative) Basic Principles 9 Appendix B (Normative) Test methods for lighting, strength and stiffness 11 Appendix C (Informative) Common Terms for Laryngoscope Peeping Parts 14 Reference 15

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 YY 0499-2004 "General Technical Conditions for Anesthesia Laryngoscope", YY 91123-1999 "Anaesthesia Laryngoscope", YY 91136-1999 "Neonatal Laryngoscope", YY 0498:1-2004 "Laryngoscope Connector Part 1: Conventional hook-type handle peeping piece Connectors" and YY 0498:2-2004 "Laryngoscope Connectors Part 2: Miniature Lamp Threads and Lamp Holders with Conventional Peepers": this document Integrate and streamline YY 0499-2004, YY 91123-1999, YY 91136-1999, YY 0498:1-2004 and YY 0498:2- Part of:2004: Compared with YY 0499-2004, except for structural adjustment and editorial changes, the main technical changes are as follows: a) The chapter "Terms and Definitions" has been added (see Chapter 3); b) Re-subdivide "Classification" into "General Requirements" and "Materials", and include the relevant content of the:2004 edition after changes (see Chapter 4, Chapter 5, Chapter 3 of the:2004 edition); c) The "requirements" and "test methods" are reclassified into "design requirements" and "performance requirements", and the relevant content of the:2004 edition is changed into (see Chapter 6 and Chapter 7, Chapter 4 and Chapter 5 of the:2004 edition); d) The chapter "Inspection Rules" has been deleted (see Chapter 6 of the:2004 edition); e) Added the chapter "Cleaning, Disinfection and Sterilization" (see Chapter 8); f) Change "marking, instruction manual" and "packaging, transportation, storage" to "information provided by the manufacturer" (see Chapter 9,:2004 edition Chapter 7, Chapter 8): This document is modified to adopt ISO 7376:2020 "Laryngoscope for Tracheal Intubation of Anesthesia and Respiratory Equipment": The technical differences between this document and ISO 7376:2020 and their reasons are as follows: --- Replaced ISO 4135 with the normatively quoted GB/T 4999 to adapt to the technical conditions of our country; --- Increased YY/T 1844-2022 to adapt to the technical conditions of our country; --- Replaced IEC 60601-1-12 with the normative reference YY 9706:112-2021 to adapt to the technical conditions of our country; --- Deleted part of Chapter 3; --- Added the description of "The dimensions given in the brackets are for reference only:" in Table 1, clarifying the actual meaning of the brackets; ---Changed the numerical description method of row t in Table 1, and clarified the actual meaning of the deviation; ---Changed the description of "the tip of the peeping piece to the lower lighting edge" and clarified its actual position; ---Change "peak current" to "peak power" to meet the actual requirements of the standard: Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed by the State Drug Administration: This document is under the jurisdiction of the National Anesthesia and Respiratory Equipment Standardization Technical Committee (SAC/TC116): The release status of previous versions of this document and the documents it replaces are as follows: ---YY 0499, first released in:2004; ---YY 91123, first released in:1999; ---YY 91136, first released in:1999; ---YY 0498:1, first released in:1999 as YY 91061-1999, first revised in:2004 as YY 0498:1-2004; ---YY 0498:2, first released in:1999 as YY 91062-1999, first revised in:2004 as YY 0498:2-2004:

Introduction

Laryngoscopes are manufactured in various forms such as one-piece laryngoscopes, non-removable articulating laryngoscope blades, removable articulating laryngoscope blades, and handle: In the latter example, the light source used to illuminate the larynx may be an illuminator affixed to the laryngoscope blade, or an illuminator in the handle: There is a light guide device in the laryngoscope blade at the same time: A minimum light output for laryngoscopes has been specified: Laryngoscope blades are defined and marked by size numbers (see Table 2), and the patient populations suitable for their design range from small premature infants to very large adults: people: Because there are too many variables, the length of the laryngoscope blade is marked on the package, so that the operator can choose the most suitable insertion blade under the condition of knowledge: tube equipment: An asterisk (*) at the beginning of a title, paragraph, or table heading indicates that there is guidance or rationale in Appendix A that is relevant to the item: Appendix B describes the test methods for illumination, stiffness and strength: Common terms for laryngoscope blade components are given in Appendix C: Anesthesia and Respiratory Equipment Laryngoscopes for Endotracheal Intubation

1 Scope

This document specifies the requirements for laryngoscopes with non-flexible blades and the requirements for handles and laryngoscope blades with interchangeable hook-on connections: critical size: This document applies to laryngoscopes with an internal battery-powered power supply for illuminating the larynx during intubation: This document does not apply to the following products: ---flexible laryngoscope; --- Laryngoscopes designed for surgery; --- Laryngoscopes powered by mains power; ---Laryngoscope connected to an external light source through an optical cable; --- Video laryngoscope designed to work in connection with an external, integrated or additional video system:

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document: GB/T 4999 Terminology of anesthesia breathing equipment (GB/T 4999-2003, ISO 4135:2001, IDT) YY 9706:112-2021 Medical Electrical Equipment Part 1-12: General Requirements for Basic Safety and Essential Performance Collateral Standards: Requirements for medical electrical equipment and medical electrical systems intended to be used in an emergency medical service environment (IEC 60601-1-12:2014, MOD) Note: There is no technical difference between the referenced content of YY 9706:112-2021 and the referenced content of IEC 60601-1-12:2014: YY/T 1844-2022 General requirements for anesthesia and respiratory equipment airway and related equipment (ISO 18190:2016, MOD) 3 *Terms and Definitions GB/T 4999, YY/T 1844-2022 and the following terms and definitions apply to this document: 3:1 contact point metal part providing the electrical connection between the articulated laryngoscope blade and the handle (3:4) 3:2 Laryngoscope blade with illuminator (3:8): 3:3 joint engagement The mechanical connection device between the blade of the laryngoscope and the handle (3:4), so that the blade can remain connected to the handle in all positions: 3:4 handle handle The part that is held in the hand during use:

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