GB 9706.255-2022Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (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 is part 2-55 of GB 9706 "Medical Electrical Equipment". GB 9706 has released the following parts.

--- Part 1.General requirements for basic safety and essential performance;

--- Part 1-3.General requirements for basic safety and essential performance Collateral standard. Radiation protection of diagnostic X-ray equipment;

--- Part 2-1.Particular requirements for the basic safety and essential performance of electron accelerators with energies ranging from 1 MeV to 50 MeV;

--- Part 2-2.Special requirements for basic safety and basic performance of high-frequency surgical equipment and high-frequency accessories;

--- Part 2-3.Special requirements for basic safety and basic performance of short-wave therapy equipment;

--- Part 2-4.Particular requirements for basic safety and basic performance of cardiac defibrillators;

--- Part 2-5.Particular requirements for basic safety and basic performance of ultrasonic physiotherapy equipment;

--- Part 2-6.Particular requirements for basic safety and basic performance of microwave therapy equipment;

--- Part 2-8.Particular requirements for basic safety and essential performance of therapeutic X-ray equipment with energy from 10kV to 1MV;

--- Part 2-11.Particular requirements for basic safety and essential performance of gamma beam therapy equipment;

--- Part 2-12.Particular requirements for basic safety and basic performance of critical care ventilators;

--- Part 2-13.Special requirements for basic safety and basic performance of anesthesia workstations;

--- Part 2-16.Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment;

--- Part 2-17.Particular requirements for basic safety and basic performance of automatically controlled brachytherapy afterloading equipment;

--- Part 2-18.Particular requirements for basic safety and essential performance of endoscopic equipment;

--- Part 2-19.Particular requirements for basic safety and basic performance of infant incubators;

--- Part 2-22.Special requirements for basic safety and essential performance of laser equipment for surgery, plastic surgery, therapy and diagnosis;

--- Part 2-24.Particular requirements for basic safety and essential performance of infusion pumps and infusion controllers;

--- Part 2-25.Specific requirements for basic safety and basic performance of electrocardiographs;

--- Part 2-26.Special requirements for basic safety and basic performance of EEG machines;

--- Part 2-27.Special requirements for basic safety and basic performance of ECG monitoring equipment;

--- Part 2-28.Particular requirements for basic safety and essential performance of medical diagnostic X-ray tube assemblies;

--- Part 2-29.Particular requirements for basic safety and basic performance of radiotherapy simulators;

--- Part 2-36.Particular requirements for the basic safety and essential performance of in vitro induced lithotripsy equipment;

--- Part 2-37.Particular requirements for basic safety and essential performance of ultrasonic diagnostic and monitoring equipment;

--- Part 2-39.Particular requirements for basic safety and basic performance of peritoneal dialysis equipment;

--- Part 2-43.Particular requirements for basic safety and essential performance of X-ray equipment for interventional operation;

--- Part 2-44.Particular requirements for basic safety and essential performance of X-ray computed tomography equipment;

--- Part 2-45.Basic safety and basic performance of mammography equipment and mammography stereotaxic devices

Require;

--- Part 2-54.Particular requirements for basic safety and essential performance of X-ray photography and fluoroscopy equipment;

--- Part 2-55.Particular requirements for basic safety and basic performance of respiratory gas monitors;

--- Part 2-60.Particular requirements for basic safety and essential performance of dental equipment;

--- Part 2-63.Particular requirements for basic safety and basic performance of dental X-ray machines for extraoral imaging;

--- Part 2-65.Particular requirements for basic safety and basic performance of dental X-ray machines for intraoral imaging;

--- Part 2-71.Particular requirements for basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment;

--- Part 2-75.Particular requirements for basic safety and essential performance of photodynamic therapy and photodynamic diagnostic equipment;

--- Part 2-83.Particular requirements for the basic safety and essential performance of household phototherapy equipment;

--- Part 2-90.Particular requirements for basic safety and essential performance of high-flow respiratory therapy equipment.

This document is modified to adopt ISO 80601-2-55.2018 "Medical Electrical Equipment Part 2-55.Basic Safety of Respiratory Gas Monitors

and Basic Performance Specific Requirements".

The technical differences between this document and ISO 80601-2-55.2018 and their reasons are as follows.

--- Replaced IEC 60601-1.2005 Amd1.2012 (see.201) with the normative reference GB 9706.1-2020, two documents

The degree of consistency between the documents is modified to suit the national conditions of our country;

--- Replaced ISO 80601-2-13.2011 Amd1.2015 Amd2 with the normative reference GB 9706.213-2021 (see

201.3), the degree of consistency between the two documents is modified to suit my country's national conditions;

--- Replaced IEC 60601-1-2.2014 (see.201.3, 202) with the normatively referenced YY9706.102, one between the two documents

The degree of consistency is modified to suit the national conditions of our country;

--- Replaced IEC 60601-1-6.2010 Amd1.2013 with normatively referenced YY/T 9706.106 (see.201.3,

206), the degree of consistency between the two documents is modified to suit my country's national conditions;

--- Replaced IEC 60601-1-8.2006 Amd1.2012 with normative reference YY9706.108-2021 (see.201.3,

208), the degree of consistency between the two documents is modified to suit my country's national conditions.

--- Replaced IEC 60601-1-11.2015 with normative reference YY9706.111-2021 (see.201.3,.201.15.3.5.

101.1, 211), the degree of consistency between the two documents is modified to suit my country's national conditions;

--- Replaced IEC 60601-1-12.2014 with normative reference YY9706.112-2021 (see.201.3,.201.15.3.5.

101.1, 212), the degree of consistency between the two documents is modified to suit my country's national conditions;

--- Replaced ISO 7010.2011 (see.201.7.2.3) with the normative reference GB/T 31523.1-2015, between the two documents

The degree of consistency is modified to suit my country's national conditions;

--- Replaced IEC 60529.2013 (see.201.11.6.5) with the normatively quoted GB/T 4208 to adapt to my country's national conditions;

--- Replaced ISO 14937.2009 (see.201.11.6.6) with the normatively quoted GB/T 19974 to adapt to my country's national conditions;

--- Replaced ISO 15223-1.2017 (see.201.7.2.13.101) with normatively referenced YY/T 0466.1-2016 to accommodate

The national conditions of our country;

--- Replaced ISO 17664.2004 (see.201.11.6.6) with the normative referenced YY/T 0802 to adapt to my country's national conditions.

The following editorial changes have been made to this document.

--- Deleted the URLs of the ISO and IEC standardized terminology databases in the introductory language of Chapter 3 in ISO 80601-2-55.2018;

--- Deleted Appendix DD "Term Index" in ISO 80601-2-55.2018.

Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.

Introduction

Safety standards for medical electrical equipment, also known as the 9706 series of standards, consist of general standards, collateral standards, specific standards, guidelines and interpretations.

---General standard. The safety standard that medical electrical equipment should be generally applicable, that is, the equipment that meets the definition of medical electrical equipment should meet this

Basic standard requirements.

--- Parallel standards. safety standards that should be generally applicable to medical electrical equipment, but in most cases are limited to certain specific functions or special

It is only the equipment that needs to meet the requirements of such standards.

---Special standards. Safety standards applicable to a certain type of medical electrical equipment, and not all medical electrical equipment have specific standards

standard.

---Guidelines and interpretations. application guidelines and explanations for the relevant requirements of the standards involved.

In the 9706 series of standards, in addition to the published standards and this document, the planned standards are as follows.

--- Part 2-66.Particular requirements for basic safety and essential performance of hearing devices and hearing device systems. The purpose is to build listening

Particular requirements for basic safety and essential performance of equipment and hearing device systems.

Items marked with an asterisk (*) in this document have specific guidelines and rationale related to the project in Appendix AA. Appendix AA

Relevant content is considered to be helpful to the correct application of this specific standard, and any version is updated when clinical application changes or technology updates

It will also be used when making necessary revisions.

Medical Electrical Equipment Part 2-55.

Basic Safety of Respiratory Gas Monitors

and basic performance-specific requirements