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GB 9706.290-2022: Medical electrical equipment -- Part 2-90:Particular requirements for basic safety and essential performance of respiratory high flow therapy equipment
GB 9706.290-2022
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.10
CCS C 46
Medical Electrical Equipment – Part 2-90: Particular
Requirements for Basic Safety and Essential Performance of
Respiratory High Flow Therapy Equipment
(ISO 80601-2-90:2021, MOD)
ISSUED ON: DECEMBER 29, 2022
IMPLEMENTED ON: JANUARY 1, 2026
Issued by: State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 4
Introduction ... 8
201.1 Scope, Object and Related Standards ... 10
201.2 Normative References ... 14
201.3 Terms and Definitions ... 16
201.4 General Requirements ... 21
201.5 General Requirements for Testing of ME Equipment ... 23
201.6 Classification of ME Equipment and ME Systems ... 24
201.7 ME Equipment Identification, Marking and Documents ... 24
201.8 Protection against Electrical Hazards from ME Equipment ... 33
201.9 Protection against Mechanical Hazards of ME Equipment and ME Systems .. 33
201.10 Protection against Unwanted and Excessive Radiation Hazards ... 35
201.11 Protection against Excessive Temperatures and Other Hazards ... 35
201.12 Accuracy of Controls and Instruments and Protection against Hazardous
Outputs ... 40
201.13 Hazardous Situations and Fault Conditions for ME Equipment ... 48
201.14 Programmable Electrical Medical Systems (PEMS) ... 50
201.15 Construction of ME Equipment ... 50
201.16 ME Systems ... 51
201.17 Electromagnetic Compatibility of ME Equipment and ME Systems ... 52
201.101 Gas Connections ... 52
201.102 Requirements for the Breathing System and Accessories ... 55
201.103 * Indication of Duration of Operation ... 57
201.104 Functional Connection ... 57
201.105 Power Supply Cords ... 58
201.106 Respiratory High-Flow Therapy Equipment Security ... 58
202 Electromagnetic Disturbances - Requirements and Tests ... 59
206 Usability ... 60
208 General Requirements, Tests and Guidance for Alarm Systems in Medical
Electrical Equipment and Medical Electrical Systems ... 62
211 Requirements for Medical Electrical Equipment and Medical Electrical Systems
Used in the Home Healthcare Environment ... 64
Annexes ... 66
Annex C (Informative) Guide to Marking and Labelling Requirements for ME
Equipment and ME Systems ... 67
Annex D (Informative) Symbols on Marking ... 74
Annex AA (Informative) Particular Guidance and Rationale ... 75
Annex BB (Informative) Data Interface Requirements ... 94
Annex CC (Informative) Reference to the IMDRF Essential Principles and
Labelling Guidance ... 99
Annex DD (Informative) Reference to the Essential Principles ... 102
Annex EE (Informative) Reference to the General Safety and Performance
Requirements ... 105
Bibliography ... 108
Foreword
This Document was drafted in accordance with the rules in GB/T 1.1-2020 Directives for
Standardization - Part 1: Rules for the Structure and Drafting of Standardizing Documents.
This Document is Part 2-90 of GB 9706 Medical Electrical Equipment. GB 9706 has published
the following parts:
--- Part 1: General requirements for basic safety and essential performance;
--- Part 2-18: Particular requirements for the basic safety and essential performance of
endoscopic equipment;
--- Part 2-19: Particular requirements for the basic safety and essential performance of infant
incubators;
--- Part 2-22: Particular requirements for basic safety and essential performance of surgical,
cosmetic, therapeutic and diagnostic laser equipment;
--- Part 2-24: Particular requirements for the basic safety and essential performance of
infusion pumps and controllers;
--- Part 2-25: Particular requirements for the basic safety and essential performance of
electrocardiographs;
--- Part 2-26: Particular requirements for the basic safety and essential performance of
electroencephalographs;
--- Part 2-27: Particular requirements for the basic safety and essential performance of
electrocardiographic monitoring equipment;
--- Part 2-28: Particular requirements for the basic safety and essential performance of X-
ray tube assemblies for medical diagnosis;
--- Part 2-29: Particular requirements for the basic safety and essential performance of
radiotherapy simulators;
--- Part 2-36: Particular requirements for the basic safety and essential performance of
equipment for extracorporeally induced lithotripsy;
--- Part 2-37: Particular requirements for the basic safety and essential performance of
ultrasonic medical diagnostic and monitoring equipment;
--- Part 2-39: Particular requirements for basic safety and essential performance of
peritoneal dialysis equipment;
--- Part 2-43: Particular requirements for the basic safety and essential performance of X-
ray equipment for interventional procedures;
--- Part 2-44: Particular requirements for the basic safety and essential performance of X-
ray equipment for computed tomography;
--- Part 2-45: Particular requirements for the basic safety and essential performance of
mammographic X-ray equipment and mammographic stereotactic devices;
--- Part 2-54: Particular requirements for the basic safety and essential performance of X-
ray equipment for radiography and radioscopy;
--- Part 2-60: Particular requirements for the basic safety and essential performance of dental
equipment;
--- Part 2-63: Particular requirements for the basic safety and essential performance of dental
extra-oral X-ray equipment;
--- Part 2-65: Particular requirements for the basic safety and essential performance of dental
intra-oral X-ray equipment;
--- Part 2-90: Particular requirements for basic safety and essential performance of
respiratory high flow therapy equipment.
This Document modified and adopted ISO 80601-2-90:2021 Medical Electrical Equipment –
Part 2-90: Particular Requirements for Basic Safety and Essential Performance of Respiratory
High-Flow Therapy Equipment.
The technical differences and causes between this Document and ISO 80601-2-90:2021 are as
follows:
--- Regarding normative reference documents, the following adjustments have been made
to this document to adapt to my country's technical conditions:
● Replace IEC 60601-1:2005+AMD1:2012+AMD2:2020 with GB 9706.1-2020,
which is a modified and adopted international standard (see Clause 201);
● Replace IEC 60601-2-12:2020 with GB 9706.212, which is modified to adopt
international standards (see 201.1.1);
● Replace IEC60601-2-13:2011 with GB 9706.213, which is modified to adopt
international standards (see 201.1.1);
● Replace ISO 4871:1996 with GB/T 14574-2000, which is equivalent to the
international standard (see 201.9.6.2.1.101);
● Replace ISO 32:1997 with GB 50751 [see 201.7.2.18 dd)];
Medical Electrical Equipment – Part 2-90:
Particular Requirements for Basic Safety and Essential
Performance of Respiratory High Flow Therapy Equipment
201.1 Scope, Object and Related Standards
Clause 1 of the general standard applies, except as follows:
201.1.1 *Scope
Replacement:
This document applies to the basic safety and essential performance of respiratory high-flow
therapy equipment, as defined in 201.3.220, hereafter also referred to as ME equipment or ME
system, in combination with its accessories:
Respiratory high-flow therapy equipment:
— intended for use with patients who can breathe spontaneously; and
— intended for patients who would benefit from improved alveolar gas exchange; a...