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GB 9706.290-2022 PDF in English


GB 9706.290-2022 (GB9706.290-2022) PDF English
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GB 9706.290-2022: PDF in English

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; and who
would benefit from receiving high-flow humidified respiratory gases, which can include
a patient whose upper airway is bypassed.
EXAMPLE 1: Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood
oxygenation.
EXAMPLE 2: Patients who would benefit from reduced work of breathing, as needed in Type 2
Respiratory Failure, where arterial carbon dioxide is high.
EXAMPLE 3: Patients requiring humidification to improve mucociliary clearance.
Respiratory high-flow therapy equipment can be intended for use in the home healthcare
environment or intended for use in professional healthcare facilities.
NOTE 1: In the home healthcare environment, the supply mains is often not reliable.
Respiratory high-flow therapy equipment can be:
— fully integrated ME equipment; or
degradation of the health of the patient.”
d) * If applicable, a warning statement to the effect that “WARNING: Do not connect the
equipment to the battery of a battery-powered wheelchair unless the connection is listed
in the instructions for use of the equipment or wheelchair as this can compromise the
equipment performance which consequently can result in degradation of the health of the
patient.”
e) A warning statement to the effect that “WARNING: To reduce the likelihood of
disconnection and to prevent adverse equipment performance use only accessories
compatible with the equipment. Compatibility is determined by reviewing the
instructions for use of either the equipment or the accessories”.
f) A warning statement to the effect that “WARNING: The high-flow mode of this equipment
is only suitable for a spontaneously breathing patient.”
g) If applicable, a warning statement to the effect that “WARNING: The therapy supplied to
the patient can be adversely affected by the gas added by the use of a pneumatic nebuliser.”
h) * A warning statement to the effect that “WARNING: It is the responsibility of the
responsible organization to ensure that the oxygen source is compatible with the rated
range of pressure, flowrate and oxygen concentration as marked on the equipment and
indicated in the instructions for use as this can affect the performance of the equipment
or pipeline system that can consequently result in serious deterioration of health.”
i) A warning statement to the effect that “WARNING: To prevent disconnection of the tubing
or tubing system during use, especially during ambulatory use, only use tubes with a
retention force in conformance with YY 0461-2003 or ISO 80601-2-74:2021”.
j) A warning statement to the effect that “WARNING: Do not use sealed patient interfaces
with this equipment, to avoid the risk of suffocation or barotrauma”.
NOTE: Full face masks, ET tubes and helmets are examples of sealed patient interfaces.
k) A warning statement to the effect that “WARNING: There is a risk of fire associated with
oxygen enrichment during oxygen therapy. Do not use the equipment or accessories near
sparks or open flames.”
l) A warning statement to the effect that “WARNING: Use only water-based lotions or salves
that are oxygen-compatible before and during oxygen therapy. Never use petroleum-
based or oil-based lotions or salves to avoid the risk of fire and burns”.
m) A warning statement to the effect that “WARNING: Do not lubricate fittings, connections,
tubing, or other accessories of the equipment to avoid the risk of fire and burns.”
n) A warning statement to the effect that “WARNING: Use only spare parts recommended
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.