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GB 9706.290-2022Medical electrical equipment—Part 2-90:Particular requirements for basic safety and essential performance of respiratory high flow therapy equipment (English PDF)

医用电气设备第2-90部分：高流量呼吸治疗设备的基本安全和基本性能专用要求

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Issued by

State Administration for Market Regulation; Standardization Administration of China

Level / Type

National · Mandatory

Issue date

December 29, 2022

Implementation date

January 1, 2026

Scope

GB 9706.290-2022 is the English-translated version of 医用电气设备第2-90部分：高流量呼吸治疗设备的基本安全和基本性能专用要求.

Clause 1 of the general standard applies, except as follows.

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Document preview — GB 9706.290-2022

National Standard of the People's Republic of China

ICS: 11.040.10
Classification: C46

Issued by: State Administration for Market Regulation; Standardization Administration of China

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

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

......

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

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