YY 9706.278-2023Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation (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 for Standardization Documents" drafting.

The "Medical Electrical Equipment" series of standards are divided into two parts.

--- Part 1. General and parallel requirements;

--- Part 2. Special requirements. This document is Part 2-78.

This document is modified to adopt IEC 80601-2-78:2019 "Medical Electrical Equipment Part 2-78. Rehabilitation, Assessment, Compensation or Palliative Medicine Special Requirements for Basic Safety and Basic Performance of Robots".

The technical differences between this document and IEC 80601-2-78:2019 and their reasons are as follows:

--- Regarding the normative reference documents, this document has made adjustments with technical differences to adapt to the technical conditions of our country and the circumstances of the adjustments The situation is reflected in 201.2 "Normative reference documents", the specific adjustments are as follows:

- Replace IEC 60601-1:2005 AMD1.2012 with GB 9706.1-2020, which adopts the revised international standard;

- Replace ISO 14971:2007 with YY/T 0316-2016, which is equivalent to the international standard;

- Replace IEC 60601-1-2:2014 with YY 9706.102-2021, which adopts the international standard;

- Replace IEC 60601-1-6:2010 AMD1.2013 with YY/T 9706.106-2021, which adopts international standards;

- Replace IEC 60601-1-8:2006 AMD1.2012 with YY 9706.108-2021, which adopts international standards;

- Replace IEC 60601-1-10:2007 A1.2013 with YY/T 9706.110-2021, which adopts international standards;

- Replace IEC 60601-1-11:2015 with YY 9706.111-2021, which adopts the revised international standard;

- Added normative reference document YY/T 1474;

- Deleted the normative reference document IEC 62366-1:2015;

- The normative reference to ISO 22523:2006 has been deleted.

---Deleted the supplementary content of 202.4.2.3.1, Chapter 202 was revised to "YY 9706.102-2021 applies". The reason is that the original English The content of 202.4.2.3.1 in the article already exists in YY 9706.102-2021.

--- Deleted 206.4.2 and 206.5 and the corresponding content of the appendix. Modifications to IEC 60601-1-6 in the original text of IEC are limited to changes The version number of the referenced standard and the addition of informative notes to the new version of the referenced standard, after deletion, are preserved with YY/T 9706.106-2021 Be consistent. The following editorial changes have been made to this document.

---Replace the informative referenced ISO 22523 with the Chinese standard GB/T 30659;

--- Added reference IEC 62366-1:2015.

Introduction

Safety standards for medical electrical equipment, also known as the 9706 series of standards, are proposed to be composed of general standards, collateral standards, specific standards, guidelines and interpretations constitute.

---General standard. The safety standard that medical electrical equipment should be generally applicable, that is, the equipment that meets the definition of medical electrical equipment should meet this Basic standard requirements.

--- Parallel standards. safety standards that should be generally applicable to medical electrical equipment, but in most cases are limited to certain specific functions or special It is only the equipment that needs to meet the requirements of such standards.

---Special standards. Safety standards applicable to a certain type of medical electrical equipment, and not all medical electrical equipment have specific standards standard.

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

This document modifies and supplements GB 9706.1-2020 "Medical Electrical Equipment Part 1. General Requirements for Basic Safety and Essential Performance Request", hereinafter referred to as the general standard.

Appendix AA contains a rationale for some of the requirements, which includes the background and reasons for certain requirements, and the identification of related issues that need to be addressed. danger. An asterisk (*) used in this document as the first character of a heading or at the beginning of a paragraph or table heading indicates that there is a Specific guides and rationale for this project.

Medical Electrical Equipment Part 2-78. Rehabilitation, Evaluation, Compensating or mitigating the basic safety and Basic performance-specific requirements