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GB 9706.255-2022: Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
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Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
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GB 9706.255-2022
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Basic data | Standard ID | GB 9706.255-2022 (GB9706.255-2022) | | Description (Translated English) | Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors | | Sector / Industry | National Standard | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Word Count Estimation | 54,512 | | Date of Issue | 2022-12-29 | | Date of Implementation | 2026-01-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB 9706.255-2022: Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
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ICS 11.040.10
CCSC46
National Standards of People's Republic of China
Medical Electrical Equipment Part 2-55.
Basic safety and
Basic performance-specific requirements
(ISO 80601-2-55.2018, MOD)
Released on 2022-12-29
2026-01-01 Implementation
State Administration for Market Regulation
Released by the National Standardization Management Committee
table of contents
Preface III
Introduction V
201.1 Scope, purpose and related criteria1
201.2 Normative references 2
201.3 Terms and Definitions 3
201.4 General requirements 5
201.5 General requirements for testing of ME EQUIPMENT 5
201.6 Classification of me equipment and me systems5
201.7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTATION 5
201.8 Protection against electric shock hazards for ME EQUIPMENT 10
201.9 Protection against mechanical hazards for ME EQUIPMENT and ME SYSTEMS 10
201.10 Protection against unwanted or excessive radiation hazards (sources)10
201.11 Protection against extreme temperatures and other hazards (sources) 10
201.12 Accuracy of controls and instruments and protection against hazardous outputs13
201.13 ME EQUIPMENT HAZARDOUS CONDITIONS AND FAULT CONDITIONS 17
201.14 Programmable electrical medical systems (PEMS) 18
201.15 Construction of ME EQUIPMENT 18
201.16 ME system 19
201.17 Electromagnetic compatibility of me equipment and me systems19
201.101* Effects of interfering gases and vapours19
201.102* Gas leaks 20
201.103* Port connector for shunt RGM 20
201.104* Sample flow rate 20
201.105* Respiratory pollution 20
201.106 Functional connection 21
202 Electromagnetic Compatibility Requirements and Tests 22
206 Availability 22
208 General requirements, tests and guidelines for alarm systems in medical electrical equipment and medical electrical systems 22
211 General requirements, tests and guidelines for medical electrical equipment and medical electrical systems for use in the home care environment 24
212 General requirements, tests and guidelines for medical electrical equipment and medical electrical systems used in emergency medical service environments 25
Appendix 26
Appendix C (informative) Guidance on marking and marking requirements for me equipment and me systems 27
Appendix D (Informative) Symbols 31
Appendix AA (informative) Special guidance and rationale 33
Appendix BB (informative) Test gas mixture for calibration 41
Appendix CC (Informative) Data Interface Requirements 42
Reference 46
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.
This document is proposed and managed by the State Drug Administration.
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
201.1 Scope, purpose and relevant standards
Except as described below, Chapter 1 of the general standard applies.
201.1.1* Scope
1.1 of the general standard is replaced by the following.
This document specifies the requirements for the basic safety and essential performance of respiratory gas monitors (RGM) intended for continuous operation and applied to patients.
with request.
This document specifies the following requirements.
---Anesthetic gas monitoring,
--- Carbon dioxide monitoring, and
--- Oxygen monitoring.
Note 1.The respiratory gas monitor can be used as a stand-alone ME equipment or integrated into other equipment, such as an anesthesia workstation or a ventilator.
This document does not apply to respiratory gas monitors intended for use with flammable anesthetic agents.
If a clause or clause clearly states that it applies only to ME EQUIPMENT, or only to ME SYSTEMS, the title and the text of the clause or clause will state that.
If this is not the case, the relevant clauses or clauses apply to both ME EQUIPMENT and ME SYSTEMS.
In addition to the general criteria 7.2.13 and 8.4.1, hazards arising from the intended physiological effects of me equipment and me systems within the scope of this document
Risks are not specifically required in this document.
Note 2.For additional information, see General Standard 4.2.
201.1.2 Purpose
General Criteria 1.2 is replaced by the following.
The purpose of this document is to establish specific basic safety and essential performance requirements for the RGM and its accessories as defined in.201.3.210.
NOTE. The accessories are included because the combination of RGM and accessories needs to be adequate for safety. Accessories have a significant impact on the basic safety and basic performance of the RGM.
201.1.3 Collateral Standards
General Standard 1.3 applies through the following additions.
This document refers to Chapter 2 of the general standard and to applicable collateral standards listed in.201.2 of this document.
GB 9706.103 and IEC 60601-1-9.2007 Amd1.2013 are not applicable.
201.1.4 Particular standards
General Criteria 1.4 is replaced by the following.
In the GB 9706 series, the specific standards can modify, replace or delete the general standards and parallel standards according to the special me equipment under consideration.
The requirements contained in the standard, and other basic safety and basic performance requirements may be supplemented.
The requirements of a particular standard take precedence over those of a general or collateral standard.
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