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

麻醉和呼吸设备气管插管用喉镜

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

March 14, 2023

Implementation date

May 1, 2026

Scope

YY 0499-2023 is the English-translated version of 麻醉和呼吸设备气管插管用喉镜.

YY 0499-2023 is the Chinese standard "Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation".

Its scope clause reads: 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:.

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Document preview — YY 0499-2023

National Standard of the People's Republic of China

ICS: 11.040.10
Classification: C46
Replacing: YY 0499-2004, YY 91123-1999, YY 91136-1999, YY 0498.1-2004, YY 0498.2-2004

Issued by: National Medical Products Administration

Preface
Introduction
1 * Range
2 Normative references
3 *Terms and Definitions
4 General requirements
5 material
6 Design requirements
7 Performance requirements
8 Cleaning, Disinfection and Sterilization
9 Information provided by the manufacturer
Appendix A (Informative) Basic Principles
Appendix B (Normative) Test methods for lighting, strength and stiffness
Appendix C (Informative) Common Terms for Laryngoscope Peeping Parts

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:

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 4135 · YY 9706 · IEC 60601 · ISO 18190

Editions of YY 0499

Edition	Title	Revision	Status
YY 0499-2023	Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation	current edition	Current
YY 0499-2004, YY 91123-1999, YY 91136-1999, YY 0498.1-2004, YY 0498.2-2004	Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation	previous edition	In force until 2026-05-01

This page sells the current edition, YY 0499-2023. Earlier editions are listed for reference only.

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