GB 9706.202-2021Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (English PDF)

Foreword

This document was drafted in accordance with the provisions of GB/T 1.1-2020

"Standardization Work Guidelines Part 1.Structure and Drafting Rules for

Standardization Documents".

This document is Part 2-2 of GB 9706 "Medical electrical equipment". GB 9706 has

released the following parts.

- Part 1.General requirements for safety;

- Part 1-3.General requirements for basic safety and essential performance -

Collateral Standard. Radiation protection in diagnostic X-ray equipment;

- Part 2-1.Particular requirements for the basic safety and essential performance of

electron accelerators in the range 1 MeV to 50 MeV;

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

high frequency surgical equipment and high frequency surgical accessories;

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

short-wave therapy equipment;

- Part 2-5.Particular requirements for the basic safety and essential performance 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 the 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 the basic safety and essential performance of

an anaesthetic workstation;

- Part 2-16.Particular requirements for the basic safety and essential performance 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 2-24.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 2-36.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 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

mammographie X-ray equipment and mammographie 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.

This document replaces GB 9706.4-2009 "Medical electrical equipment - Part 2-2.

Particular requirements for the safety of high frequency surgical equipment". Compared

with GB 9706.4-2009, except for structural adjustment and editorial changes, the main

technical changes are as follows.

- ADD the related content of high current mode (see 3.219, 12.4.101 of this

document);

- AMEND the definition of "high frequency" by adding the upper limit of frequency

(see 3.220 of this document, see 2.12.108 of the 2009 edition);

- ADD the relevant content of conditions for application and evaluating risk in the

general requirements (see 4 of this document);

- ADD additional information in instructions for use. description of neuromuscular

stimulation, non-continuous activation, accessories and the maximum allowable

length of accessories and cords (see 7.9.2.2.101);

- AMEND the limit for high frequency leakage current of active accessories (see

11 to the bibliography;

- DELETE the index of defined terms of the international standard.

Attention is drawn to the possibility that some of the elements of this document may be

the subject of patent rights.

The issuing authority shall not be held responsible for identifying any or all such patent

rights.

1 Scope, object and related standards

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

2 Normative references

The following referenced documents are indispensable for the application of this

document. For dated references, only the edition cited applies. For undated references,

the latest edition of the referenced document (including any amendments) applies.

Clause 2 of the general standard applies, except as follows.

3 Terms and definitions

For the purposes of this document, the terms and definitions given in the general

standard and the following apply.

4 General requirements

Clause 4 of the general standard applies, except as follows.

5 General requirements for testing of ME EQUIPMENT

Clause 5 of the general standard applies, except as follows.

6 Classification of ME EQUIPMENT and ME SYSTEMS

Clause 6 of the general standard applies.

7 ME EQUIPMENT identification, marking and documents

Clause 7 of the general standard applies, except as follows.

8 Protection against electrical HAZARDS from ME

EQUIPMENT

Clause 8 of the general standard applies, except as follows.

9 Protection against MECHANICAL HAZARDS of ME

EQUIPMENT and ME SYSTEMS

Clause 9 of the general standard applies.

10 Protection against unwanted and excessive radiation

HAZARDS

Clause 10 of the general standard applies.

11 Protection against excessive temperatures and other

HAZARDS

15 Construction of ME EQUIPMENT

Clause 15 of the general standard applies, except as follows.

202 * ELECTROMAGNETIC DISTURBANCES - Requirements and tests

YY 9706.102-2021 applies except as follows.