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GB 9706.203-2020Medical electrical equipment - Part 2-3: - Particular requirements for the basic safety and essential performance of short-wave therapy equipment (English PDF)

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Issued by

SAMR; SAC

Level / Type

National · Mandatory

Issue date

May 29, 2020

Implementation date

May 1, 2023

Scope

GB 9706.203-2020 (Medical electrical equipment - Part 2-3: - Particular requirements for the basic safety and essential performance of short-wave therapy equipment) is available as an English-translated PDF.

GB 9706.203-2020 — Replacement. This Part of GB 9706 specifies the requirements for the safety of SHORT-WAVE THERAPY EQUIPMENT, hereafter referred to as ME EQUIPMENT. The defined LOW POWER EQUIPMENT is exempted from certain requirements of this Part. NOTE. Some of the more important requirements are annotated in the "Special Guidance and Explanation" section, see Annex AA. Clauses or subclauses corresponding to annotations in Annex AA are marked with an asterisk (*).

Document preview — GB 9706.203-2020

National Standard of the People's Republic of China

Issued by: SAMR; SAC

Contents

  • Foreword...3
  • 201.1 Scope, object and related standards...6
  • 201.2 Normative References...7
  • 201.3 Terms and Definitions...8
  • 201.4 General requirements...8
  • 201.5 General requirements for testing of ME EQUIPMENT...8
  • 201.6 Classification of ME EQUIPMENT and ME SYSTEMS...9
  • 201.7 ME EQUIPMENT identification, marking and documents...9
  • 201.8 Protection against electrical HAZARDS from ME EQUIPMENT...11

Foreword

All technical content of this Part is mandatory.

GB 9706 Medical Electrical Equipment is divided into the following parts.

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

- Part 1-3.General requirements for safety - 3.Collateral standard. General requirements

for radiation protection in diagnostic X-ray equipment

- Part 2-1.Particular requirements for the safety of electron accelerators in the range 1 MeV

to 50 MeV;

- Part 2-2.Particular requirements for the safety of high frequency surgical equipment;

- Part 2-3.Particular requirements for the basic safety and essential performance of short-

wave therapy equipment;

- Part 2-4.Particular requirements for the safety of cardiac defibrillators;

- Part 2-5.Particular requirements for the safety of ultrasonic physiotherapy equipment;

- Part 2-6.Particular requirements for the basic safety and essential performance of

microwave therapy equipment;

- Part 2-8.Particular requirements for basic safety and essential performance of therapeutic

X-ray equipment operating in the range 10 kV to 1 MV;

- Part 2-11.Particular requirements for the basic safety and essential performance of gamma

beam therapy equipment;

- Part 2-12.Particular requirements for basic safety and essential performance of critical

care ventilators;

- Part 2-13.Particular requirements for basic safety and essential performance of an

anaesthetic workstation;

- Part 2-16.Particular requirements for the safety of haemodialysis, haemodiafiltration and

haemofiltration equipment;

- Part 2-17.Particular requirements for the basic safety and essential performance of

automatically-controlled brachytherapy after-loading equipment;

- 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 safety 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

electroencephalograph;

- 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 the safety of peritoneal dialysis equipment;

- Part 2-43.Particular requirements for the safety 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 safety 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;

Medical electrical equipment - Part 2-3.Particular

requirements for the basic safety and essential performance

of short-wave therapy equipment

201.1 Scope, object and related standards

Clause 1 of the GB 9706.1-2020 applies, except as follows.

201.1.1 Scope

Replacement.

This Part of GB 9706 specifies the requirements for the safety of SHORT-WAVE THERAPY

EQUIPMENT, hereafter referred to as ME EQUIPMENT.

The defined LOW POWER EQUIPMENT is exempted from certain requirements of this Part.

NOTE. Some of the more important requirements are annotated in the "Special Guidance and

Explanation" section, see Annex AA. Clauses or subclauses corresponding to annotations in Annex AA

are marked with an asterisk (*).

201.1.2 Object

Replacement.

The object of this Part is to establish particular BASIC SAFETY and ESSENTIAL

PERFORMANCE requirements for SHORT-WAVE THERAPY EQUIPMENT as defined in

201.3.206.

201.1.3 Collateral standards

Addition.

This Part refers to those applicable collateral standards that are listed in Clause 2 of GB 9706.1-

2020.

201.1.4 Particular standards

Replacement.

In the particular standards may modify, replace or delete requirements contained in the general

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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.

Referenced standards

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