YY/T 1873-2023 English PDF

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YY/T 1873-2023: Anaesthetic and respiratory equipment - Nitrous oxide inhalation sedation and analgesia equipment
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1873-2023	539	Add to Cart	5 days	Anaesthetic and respiratory equipment - Nitrous oxide inhalation sedation and analgesia equipment	Valid

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Basic data

Standard ID: YY/T 1873-2023 (YY/T1873-2023)
Description (Translated English): Anaesthetic and respiratory equipment - Nitrous oxide inhalation sedation and analgesia equipment
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C46
Classification of International Standard: 11.040.10
Word Count Estimation: 26,280
Date of Issue: 2023-06-20
Date of Implementation: 2024-07-01
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the basic safety and basic performance of nitrous oxide inhalation sedative and analgesic devices used in combination with accessories. This standard applies to nitrous oxide inhalation sedative and analgesic devices and accessories used in combination (such as masks, breathing circuits, etc.). This type of device is expected to deliver nitrous oxide and oxygen mixture to the patient's respiratory system for sedation and analgesia, and the concentration of the nitrous oxide and oxygen mixture delivered by it can be adjusted. This standard does not apply to anesthesia machines that use nitrous oxide for inhalational sedation and analgesia, and nitrous oxide premixed gas inhalation sedation and analgesia devices.

YY/T 1873-2023: Anaesthetic and respiratory equipment - Nitrous oxide inhalation sedation and analgesia equipment

---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.
Published on 2023-06-20 2024-07-01 Implementation ICS 11.040.10CCS C 46 Anesthesia and respiratory equipment Laughing gas inhalation sedation and analgesia device Anaesthetic and respiratory equipment- Nitrous oxide inhalation sedation and analgesia equipment

Table of contents

PrefaceⅠ 1 Scope 1 2 Normative reference documents 1 3 Terms and Definitions 2 4 General requirements 3 5 Material Compatibility5 6 Power supply 6 7 Accuracy of controllers and instruments and protection of hazardous outputs 8 8 leaks 12 9 connection port 12 10 Cleaning, Disinfection and Sterilization12 11 Additional requirements for accessories13 12 Logo, marking and documentation13 Appendix A (Normative) Oxygen monitoring device accuracy and low oxygen concentration alarm test 17 Appendix B (informative) Correspondence between YY/T 0893-2023 and the corresponding provisions of this document 19 Appendix C (normative) nitrous oxide concentration and oxygen concentration control accuracy test 21

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed by the National Medical Products Administration. This document is under the jurisdiction of the National Technical Committee on Standardization of Anesthesia and Respiratory Equipment (SAC/TC 116). This document was drafted by. Nanjing Supstar Medical Equipment Co., Ltd., Shanghai Medical Device Inspection and Research Institute, National Drug Supervision and Administration Medical Device Technical Evaluation Center of the State Council. The main drafters of this document. Meng Baolin, Yang Xiaoqing, Zhong Youjin, Wang Wei, Tang Xuefeng, and Wang Wei. Anesthesia and respiratory equipment Laughing gas inhalation sedation and analgesia device

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 ......

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