GB 9706.226-2021Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (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"

Drafting.

This document is part 2-26 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 basic performance Parallel standard. Radiation protection of diagnostic X-ray equipment;

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

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

---Part 2-3.Special requirements for basic safety and basic performance of shortwave treatment equipment;

---Part 2-4.Special requirements for the basic safety and basic performance of cardiac defibrillators;

---Part 2-5.Special requirements for the basic safety and basic performance of ultrasonic physical therapy equipment;

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

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

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

---Part 2-12.Special requirements for the basic safety and basic performance of intensive care ventilators;

---Part 2-13.Special requirements for the basic safety and basic performance of the anesthesia workstation;

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

---Part 2-17.Special requirements for the basic safety and basic performance of automatic control brachytherapy after-installation equipment;

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

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

---Part 2-22.Special requirements for basic safety and basic performance of laser equipment for surgery, plastic surgery, treatment and diagnosis;

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

---Part 2-25.Special requirements for basic safety and basic performance of electrocardiograph;

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

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

---Part 2-28.Special requirements for the basic safety and basic performance of medical diagnostic X-ray tube components;

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

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

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

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

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

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

---Part 2-45.The basic safety and basic performance of mammography equipment and mammography stereotaxic devices

Require;

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

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

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

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

---Part 2-66.Special requirements for basic safety and basic performance of hearing equipment and hearing equipment system.

This document replaces GB 9706.26-2005 "Medical Electrical Equipment Part 2-26.Special Requirements for the Safety of EEG Machines". This document and

Compared with GB 9706.26-2005, in addition to structural adjustments and editorial changes, the main technical changes are as follows.

--- Changed the scope of application and deleted the brain function monitor (see.201.1.1,.2005 edition 1.1);

--- Increased performance requirements (see.201.12.1), and stipulated the basic performance (see.201.4.3.).

This document uses the redrafting method to modify and adopt IEC 60601-2-26.2012 "Medical Electrical Equipment Part 2-26.EEG Machine

Special requirements for basic safety and basic performance.

The technical differences between this document and IEC 60601-2-26.2012 and the reasons are as follows.

---Regarding normative reference documents, this document has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.

The situation is collectively reflected in.201.2 "Normative Reference Documents", and the specific adjustments are as follows.

- Replace IEC 60601-1.2005 with GB 9706.1-2020, which is modified to adopt international standards;

- Replace IEC 60601-1-2.2007 with YY9706.102-2021 which is modified to adopt international standards;

- Added GB/T 4208-2017;

- Removed IEC 60601-2-27.2011 and adjusted to references.

The following editorial changes have been made to this document.

---The term index of the international standard has been deleted.

Introduction

The safety standards for medical electrical equipment are also known as the 9706 series of standards, which are to be composed of general standards, parallel standards, special standards, guidelines and interpretations

constitute.

---General standards. 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.

---Parallel standards. Medical electrical equipment should be generally applicable to safety standards, but in most cases it is limited to certain specific functions or features.

Sexual equipment only needs to meet the requirements of such standards.

---Special standards. safety standards that a certain type of medical electrical equipment should apply, and not all medical electrical equipment have special

standard.

---Guidelines and explanations. application guidelines and explanations for the relevant requirements in the standards involved.

In the GB 9706 series of standards, in addition to the published standards and this document, the standards that have been included in the plan are as follows.

---Part 2-4.Special requirements for the basic safety and basic performance of cardiac defibrillators;

---Part 2-22.Special requirements for basic safety and basic performance of laser equipment for surgery, plastic surgery, treatment and diagnosis;

---Part 2-66.Special requirements for basic safety and basic performance of hearing equipment and hearing equipment system.

This document deals with the basic safety and basic performance specific requirements of EEG machines. This document revised and supplemented GB 9706.1-2020

"Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Basic Performance."

The requirements of this document have a higher priority than general standards.

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

Dedicated guides and principle explanations related to the project. The relevant content of Appendix AA is not only helpful for the correct use of this document, but also can be added in a timely manner.

The process of revising standards due to changes in clinical practice or technological development.

Medical electrical equipment-Part 2-26.EEG machine

Special requirements for basic safety and basic performance