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

麻醉和呼吸设备笑气吸入镇静镇痛装置

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 20, 2023

Implementation date

July 1, 2024

Scope

YY/T 1873-2023 is the English-translated version of 麻醉和呼吸设备笑气吸入镇静镇痛装置.

YY/T 1873 covers the apparatus that delivers nitrous oxide and oxygen for conscious sedation and analgesia, the equipment used in dentistry, minor procedures and labour wards. It specifies the requirements such a device has to meet and the test methods that verify them, covering the gas mixing and delivery system, the limits that prevent a hypoxic mixture being given, the alarms and the scavenging that protects the staff working in the room. The safety case rests on interlocks: the device must make it difficult to deliver too much nitrous oxide and impossible to deliver too little oxygen. Nitrous oxide sedation is expanding quickly in Chinese dental practice, which is what makes a dedicated standard necessary. For a manufacturer, this is the product-specific text a Chinese registration is assessed against.

Document preview — YY/T 1873-2023

National Standard of the People's Republic of China

ICS: 11.040.10
Classification: C46

Issued by: National Medical Products Administration

1 Scope1
2 Normative reference documents1
3 Terms and Definitions2
4 General requirements3
6 Power supply6
7 Accuracy of controllers and instruments and protection of hazardous outputs 8 8 leaks 12 9 connection port12
19 Appendix C (normative) nitrous oxide concentration and oxygen concentration control accuracy test21

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

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 1962.2-2001 · GB/T 3767-2016 · GB/T 4999-2003 · GB 9706.213 · GB 9706.255-2022 · GB/T 15383-2011 · GB 18278.1 · GB 18279.1 · GB 50751 · YY/T 0316 · YY 0461 · YY/T 0799 · YY/T 0802-2020

Similar standards

YY/T 1543|YY/T 0799|YY 0671.1|YY/T 1438|YY 9706.287

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