YY 0499-2023Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (English PDF)

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;

1 Scope

YY 0499 is the mandatory Chinese standard for laryngoscopes used in tracheal intubation, the instruments that lift the tongue and epiglottis so that a tube can be passed into the trachea. It sets the requirements such an instrument has to meet and the test methods that verify them, covering the dimensions and fit of blade and handle, the illumination the light source provides, the mechanical strength of the assembly, the materials and the cleaning and sterilization the instrument must withstand. Intubation is often performed on a patient who has stopped breathing, in poor light and under time pressure, so a blade that detaches or a lamp that fails at the wrong moment is a life-threatening fault. The 2023 edition consolidates and replaces five earlier standards and takes effect in May 2026.

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: