YY 9706.246-2023Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables (English PDF)

Foreword

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 2-46.

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.

This document replaces YY 0570-2013 "Medical Electrical Equipment Part 2: Special Requirements for Operating Table Safety". This document is consistent with YY 0570- Compared with.2013, the main technical changes are as follows.

---Renumber the clauses of this document according to the clause numbers of GB 9706.1-2020;

--- Added basic performance requirements (see.201.4.3);

---Modified some test methods (see.201.9, 202, Chapter 4, Article 36 of the 2013 edition).

This document is modified to adopt IEC 60601-2-46:2016 "Medical Electrical Equipment Part 2-46.Basic Safety and Essential Performance of Operating Tables Special Requirements". The technical differences between this document and IEC 60601-2-46:2016 and their 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 Centrally reflected in 201.2 "Normative Reference Documents", the specific adjustments are as follows.

- Replace IEC 60601-1:2012 with GB 9706.1-2020, which adopts international standards;

- Replace IEC 60601-1-3:2008 AMD1.2013 with GB 9706.103-2020, which adopts the revised international standard;

- Replace IEC 60601-1-2:2007 with YY 9706.102-2021, which is equivalent to the international standard;

- Replace IEC 60601-2-2 with GB 9706.202, which adopts international standards;

- Replace IEC 60601-2-43 with GB 9706.243 which adopts international standard.

---When a series of standards and different versions of the same standard are involved in the document, the series of standards with corresponding relations have not been transformed in China or the relevant version of the standard was not converted. Therefore, in order to maintain the meaning consistent with the original text, the International Standard number is retained.

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. explanations for the application guidelines and clauses of the relevant requirements in the standards involved.

This document deals with the basic safety and essential performance of operating tables. This document modifies and supplements GB 9706.1-2020 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance", hereinafter referred to as general standards.

The requirements of this document take precedence over those of the general standard.

An asterisk (*) used as the first character of a title or the beginning of a paragraph or table title in this document indicates that there is a relevant item in Appendix AA.

Project-specific guidelines and rationale. The relevant content of Appendix AA is not only helpful to the correct use of this document, but also when used in clinical practice.

After changes or technological developments, the process of revising standards can be accelerated in a timely manner. However, Appendix AA is not part of the requirements of this document.

Medical electrical equipment - Part 2-46.Operating tables Particular requirements for basic safety and essential performance