GB 9706.222-2022Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (English PDF)

foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"

drafted.

This document is part 2-22 of GB 9706 "Medical Electrical Equipment". GB 9706 has released the following parts.

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

--- Part 1-3.General Requirements for Basic Safety and Essential Performance Collateral Standard. Radiation Protection of Diagnostic X-ray Equipment;

--- Part 2-1.Specific requirements for basic safety and basic performance of electron accelerators with energies from 1MeV to 50MeV;

--- Part 2-2.Special requirements for basic safety and basic performance of high-frequency surgical equipment and high-frequency accessories;

--- Part 2-3.Specific requirements for basic safety and basic performance of shortwave therapy equipment;

--- Part 2-5.Specific requirements for the basic safety and basic performance of ultrasonic physiotherapy equipment;

--- Part 2-6.Specific requirements for basic safety and basic performance of microwave therapy equipment;

--- Part 2-8.Particular requirements for basic safety and basic performance of therapeutic X-ray equipment with energy from 10kV to 1MV;

--- Part 2-11.Particular requirements for basic safety and basic performance of gamma beam therapy equipment;

--- Part 2-12.Specific requirements for basic safety and basic performance of critical care ventilators;

--- Part 2-13.Particular requirements for basic safety and basic performance of anesthesia workstations;

--- Part 2-16.Particular requirements for basic safety and basic performance of hemodialysis, hemodiafiltration and hemofiltration equipment;

--- Part 2-17.Special requirements for the basic safety and basic performance of automatically controlled brachytherapy afterloading equipment;

--- Part 2-18.Particular requirements for basic safety and basic performance of endoscopic equipment;

--- Part 2-19.Specific requirements for the basic safety and basic performance of infant incubators;

--- Part 2-22.Particular requirements for the basic safety and basic performance of laser equipment for surgical, orthopedic, therapeutic and diagnostic use;

--- Part 2-24.Particular requirements for basic safety and basic performance of infusion pumps and infusion controllers;

--- Part 2-25.Particular requirements for basic safety and basic performance of electrocardiographs;

--- Part 2-26.Specific requirements for basic safety and basic performance of EEG machines;

--- Part 2-27.Particular requirements for basic safety and basic performance of ECG monitoring equipment;

--- Part 2-28.Particular requirements for basic safety and basic performance of medical diagnostic X-ray tube assemblies;

--- Part 2-29.Specific requirements for basic safety and basic performance of radiotherapy simulators;

--- Part 2-36.Particular requirements for the basic safety and basic performance of in vitro induced lithotripsy equipment;

--- Part 2-37.Particular requirements for basic safety and basic performance of ultrasonic diagnostic and monitoring equipment;

--- Part 2-39.Particular requirements for basic safety and basic performance of peritoneal dialysis equipment;

--- Part 2-43.Particular requirements for basic safety and basic performance of interventional X-ray equipment;

--- Part 2-44.Particular requirements for the basic safety and basic performance of X-ray computed tomography equipment;

--- Part 2-45.Special use for basic safety and basic performance of mammography equipment and mammography stereotaxic devices

Require;

--- Part 2-54.Particular requirements for basic safety and basic performance of X-ray photography and fluoroscopy equipment;

--- Part 2-60.Particular requirements for basic safety and basic performance of dental equipment;

--- Part 2-63.Special requirements for basic safety and basic performance of dental X-ray machines for extraoral imaging;

--- Part 2-65.Special requirements for basic safety and basic performance of intraoral imaging dental X-ray machines.

This document replaces GB 9706.20-2000 "Medical electrical equipment - Part 2.Special requirements for the safety of diagnostic and therapeutic laser equipment

Compared with GB 9706.20-2000, in addition to structural adjustment and editorial changes, the main technical changes are as follows.

--- The general part refers to GB 9706.1-2020;

--- Modified the scope and purpose (see Chapter 1 of.201.1,.2000 edition);

--- Added normative references (see.201.2);

--- Delete the terms "aiming spot", "(medical) laser equipment", "shutter" and "working laser" (see 2.1.103 of the.2000 edition,

2.1.111, 2.1.116 and 2.1.121);

---Added "Class 1C", "Enclosed Laser", "Good Contact", "Laser Emission Control Switch", "Laser Operator", "Maximum Allowable Irradiation"

terms and definitions of "quantity" and "stray light radiation" (see.201.3.206,.201.3.212,.201.3.213,.201.3.214,.201.3.217,

Introduction

Medical electrical equipment safety standards, also known as the 9706 series of standards, consist of general standards, side-by-side standards, specific standards, guidelines and interpretations.

---General standard. Medical electrical equipment should be generally applicable to safety standards, that is, equipment that meets the definition of medical electrical equipment should meet this

Basic standard requirements.

--- Side-by-side standard. Medical electrical equipment should be generally applicable to the safety standards, but in most cases only limited to some specific functions or special

Only devices that are sexual are required to meet the requirements of such standards.

---Special standard. a safety standard applicable to a certain type of medical electrical equipment, and not all medical electrical equipment has special

standard.

---Guidelines and interpretations. interpretations of the application guidelines and clauses of the relevant requirements in the standards involved.

In the GB 9706 series of standards, in addition to the published standards and this document, the planned standards are as follows.

--- Part 2-4.Particular requirements for basic safety and basic performance of cardiac defibrillators. The aim is to establish the basics of a cardiac defibrillator

Specific requirements for safety and essential performance.

--- Part 2-66.Specific requirements for the basic safety and basic performance of hearing devices and hearing device systems. The purpose is to establish a listening

Particular requirements for basic safety and basic performance of force equipment and hearing equipment systems.

This document addresses basic safety and essential performance requirements for surgical, orthopedic, therapeutic and diagnostic laser equipment. This document modifies and supplements

GB 9706.1-2020 "Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Basic Performance".

In this document, an asterisk (*) is used as the first character of a title or the beginning of a paragraph or table title, indicating that there is a reference to this item in Appendix AA.

Specific guidelines and principles related to the project are provided. The relevant content of Appendix AA will not only help to use this document correctly, but also add it in a timely manner.

Rapid process of revision of standards due to changes in clinical practice or technological developments.

Medical Electrical Equipment Part 2-22.Surgical, Orthopaedic,

Basic safety and

Specific requirements for basic performance