YY 0783-2010Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipments (English PDF)

Foreword

All the technical content of this specific standard is mandatory.

Medical electrical equipment standard series of standards, the series standard consists of two parts.

--- Part 1. General requirements for safety of medical electrical equipment;

--- Part 2. Medical electrical equipment requirements for the safety.

This special standard - Part 2-34 Medical electrical equipment. This standard is based on GB 9706.1-2007 "Medical electrical equipment - Part 1 Part I. General Requirements for Safety "(General Standard) of the specific standards, and supporting the use of GB 9706.1. This is a specific standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" of changes and additions.

The use of specific standard translation method identical with IEC 60601-2-34:2000 "Medical electrical equipment - Part 2. invasive blood pressure monitoring Equipment safety and essential performance. " The specific standard IEC 60601-2-34:2000 made the following editorial changes.

--- Use the decimal symbol instead of the international standard in decimal notation ",". ",";

--- Other international standards quoted in the standard, if it has the appropriate standards into our country, places of reference standards prevail;

--- Remove IEC 60601-2-34:2000 cover and foreword, according to GB/T 1.1-2009 asked to re-write;

--- By IEC 60601-2-34:2000 Electromagnetic compatibility in part of IEC 60601-1-2:1993 Edition, press YY 0505-2005 (identical with IEC 60601-1-2:2001) of Clause No. editorial changes.

The specific standard Chapter 36 Electromagnetic Compatibility YY 0505-2005 "Medical electrical equipment - Part 1-2. General requirements for safety and Standard column. EMC requirements and tests "implemented simultaneously.

The specific standard of medical equipment by the National Standardization Technical Committee of Standardization Technical Committee of Medical Appliances (SAC/TC10 / SC5) centralized.

Introduction

General Standard does not include "direct blood pressure monitoring equipment," the safety and essential performance requirements. Therefore, we need to make changes to cover Cover these special requirements. The specific standard considers the collateral standard YY 0505-2005 electromagnetic compatibility, and standard parallel

YY/T 0708-2009 Medical electrical equipment with programmable electrical system. It also includes a chapter on the alarm strip, since the alarm One of the functions of monitoring equipment is required. Medical electrical equipment - Part 2-34.

There is safety and essential performance of invasive blood pressure monitoring equipment requirements for The first chapter outlines Except as follows General Standard clauses apply to this Title.

1 Scope and purpose

Except as follows, common standards in this chapter apply.

2 Terms and definitions

Except as follows, common standards in this chapter apply.