YY/T 1873-2023Anaesthetic and respiratory equipment - Nitrous oxide inhalation sedation and analgesia apparatus (English PDF)

1 Scope

This document specifies the basic safety and essential performance of laughing gas inhalation sedation and analgesic devices used in combination with accessories.

This document applies to laughing gas inhalation sedation and analgesia devices and accessories used in combination (such as masks, breathing tubes, etc.). Such devices are expected to cause

The patient's respiratory system delivers nitrous oxide and oxygen mixed gases for sedation and analgesia, and the concentration of the nitrous oxide and oxygen mixed gases it delivers can be adjusted.

This document does not apply to anesthesia machines that use laughing gas for inhalation sedation and analgesia, and laughing gas and oxygen premixed gas inhalation sedation and analgesia devices.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations

For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document.

document.

GB/T 1962.2-2001 6% (Luer) conical connectors for syringes, injection needles and other medical devices Part 2.Locking connectors

GB/T 3767-2016 Acoustic sound pressure method for determining the sound power level and sound energy level of noise sources in the approximate free field above the reflecting surface

Cheng Fa

GB/T 4999-2003 Terminology for anesthesia respiratory equipment

GB 9706.1-2020 Medical electrical equipment Part 1.General requirements for basic safety and basic performance

GB 9706.213 Medical electrical equipment Part 2-13.Special requirements for basic safety and basic performance of anesthesia workstations

GB 9706.255-2022 Medical electrical equipment Part 2-55.Basic safety and basic performance of respiratory gas monitors

Require

GB/T 15383-2011 Gas cylinder valve air outlet connection type and size

GB 18278.1 Moist heat sterilization of healthcare products Part 1.Development, validation and routine control of sterilization processes for medical devices

Require

GB 18279.1 Ethylene oxide for sterilization of health care products Part 1.Development, validation and routine control of medical device sterilization process system requirements

GB 18280.1 Radiation sterilization of health care products Part 1.Development, validation and routine control of sterilization processes for medical devices

Require

GB 50751 Technical specifications for medical gas engineering

YY/T 0297 Clinical Investigation of Medical Devices

YY/T 0316 Application of medical device risk management to medical devices

YY 0461 Breathing tubes for anesthesia machines and ventilators

YY/T 0466.1-2016 Medical devices Symbols used for labeling, marking and providing information on medical devices Part 1.General

Require

YY/T 0799 Medical gas low pressure hose assembly

YY/T 0802-2020 Disposal of medical devices Information provided by medical device manufacturers

YY/T 0893-2023 Medical gas mixer independent gas mixer […]